Almost half of adults in Scotland with a neurological condition have experienced delays to access a routine appointment, according to a new study.

Research by the Neurological Alliance of Scotland also found that more than a third of adults (37%) waited more than a year for a diagnosis.

Meanwhile, nearly all children and young people (95%) and a majority of adults (80%) said that their neurological condition negatively impacts on their mental health.

The study also indicated that four in ten adults (40%) said that their mental health needs were not being met at all, whilst 55% of adults said they havent been asked about their mental wellbeing in the last three years.

And only 36% of adults and 26% of children and young people told the study that they completely understood the explanation of their condition given at diagnosis.

In its findings, the report highlights the profound impact of the coronavirus pandemic, whilst warning of a disproportionate impact of the cost-of-living crisis on those with neurological conditions.

The document also outlines that there is currently only one ME specialist nurse available in the whole of Scotland.

Alice Struthers, Neurological Alliance of Scotland programme director, said that it is alarming that most people with a neurological condition are unable to access the mental wellbeing support they need.

And she insisted that action must be taken to deliver care seamlessly between different parts of the health system in Scotland.

One in six people live with a neurological condition, but we do not have the workforce or services in place to provide the support they need, she said.

Delays to treatment and care can change your life forever, and it is of huge concern that people living with a neurological condition in Scotland have experienced such lengthy delays for routine appointments.

And it is alarming that most people with a neurological condition are unable to access the mental wellbeing support they need.

Finding out that you have a neurological condition is scary and confusing, and receiving the right information and support can make a real difference.

Action must be taken in Scotland to deliver care seamlessly between different parts of the health system, address the mental health crisis, and better understand the prevalence of neurological conditions so that we can create real and positive change for hundreds of thousands of people in Scotland.

A Scottish Government spokesperson said that long waiting lists are not acceptable and offered their sympathies to those patients waiting for treatment.

We are determined to improve the provision of neurological care, which is why we funded this important Patient Experience Survey from the Neurological Alliance Scotland. It is vital that people with neurological conditions feel enabled and involved in their care, they said.

Understanding the perspectives of those who access health care in Scotland will enable us to work together to identify good practice and drive up standards.

Long waiting lists are not acceptable, and we offer our sympathies to all patients waiting for treatment. We are working closely with NHS Boards to get those waiting for treatment the care they need as quickly as possible. Throughout the pandemic, NHS Boards have ensured that urgent services have continued as usual.

We are encouraged to see decreases in long waits for psychological therapies in Scotland, despite an increase in demand.

We provided an additional 9m to NHS boards to address waiting lists for PT and NHS staff have worked hard to address the backlogs.

Since 2007 psychology services staffing has doubled and we continue to support the creation of new posts.

We will continue to support all boards to clear mental health backlogs and meet the waiting times standard by March 2023.

We are currently refreshing our mental health strategy and are engaging with a range of organisations to help inform our approach. This will include engaging with Neurological Alliance of Scotland and Neuropsychological leads.

Scottish Conservative mental wellbeing spokesperson Sue Webber insisted that those with neurological conditions should not have to suffer in silence and must be seen quickly.

This survey paints an alarming picture for those with neurological conditions in Scotland and their ability to access mental health treatment system under the SNP, she said.

The vast majority of people living with neurological conditions say that their illness is impacting their mental health, yet these one million Scots are being badly let down.

People with neurological conditions, such as cerebral palsy, stroke, dementia and epilepsy, should not have to suffer in silence, and must be seen quickly.

The SNP must stop ignoring the needs of this significant group of the population and urgently act to ensure everyone in Scotland can easily and quickly access support for both their mental and physical health.

Growing up in Aberdeen, Mia was fit, happy and healthy.

She was on the Scottish Rhythmic Gymnastics Squad and competed around the UK, winning several medals.

At the age of 12, however, her life was turned upside down after being diagnosed with ME (myalgic encephalomyelitis), commonly known as chronic fatigue syndrome.

Mia would watch as her friends went on to college or jobs, whilst being unable to do so herself.

Now 18, Mia explains she has been left feeling totally lost and devastated following several visits to doctors and hospitals.

Over the last six years I have missed out on schooling, had to give up my gymnastics, and have missed out on most things that teenage girls do, she said.

Ive learned to try and manage according to what my body allows me to do.

Throughout the years, we have found that there is no help or understanding for people suffering with ME.

I have had several visits to doctors and hospitals and we have been left feeling totally lost and devastated. There has never been any empathy or help.

We have had to try find alternative treatments and pay for them ourselves with just a little bit of hope each time that at that point it would ease my symptoms and pain even if just for a little while.

Having previously worked in retail, Shannon was diagnosed with relapsing-remitting MS in January this year.

She was hospitalised for three weeks and had little to no function of her left leg, as well as weakness in her ankle and knee cap.

After being discharged from hospital at the start of February, she was told that she would receive physiotherapy at home once a week.

However, that didnt happen, with Shannon having to chase up the physiotherapy.

I still havent received any physio since being discharged on February 3, said Shannon.

I have done a lot at home myself to get me to a stage of being able to take small steps very wobbly without aids.

Im very determined to gain as much leg function back as I can and, if I have to do it myself due to the NHS letting me down, then thats what Ill do as I dont have much choice.

She added: My foot is still pretty weak and I walk with my foot at an angle rather than flat on the ground and Im unable to straighten my leg when walking.

I was without treatment for about eight weeks due to the pharmacist not delivering it, and I again had to chase this up.

Donald, who works for Glasgow City Council as a Gaelic development officer, has had cervical dystonia for nearly 40 years, affecting his neck and shoulders.

He attends regular appointments for botulinum toxin injections which helps to relax his muscles and straighten the twist in his form.

Every three months, he also attends the National Hospital of Neurology and Neurosurgery in London for electromyographic guided injections.

However, he was unable to access GP and other services during the coronavirus pandemic and could not travel to London.

I didnt have access to the botulinum toxin injections that I used to have every three months because of restrictions on travel and hospital and GP services at that time, he said.

It meant that rather than getting my injections every 12 weeks I was waiting at least 26 weeks or more.

My head is twisted over to the side and my shoulder comes up, and the injection is supposed to alleviate that to an extent although it doesnt take it all away.

Donald explains that not having access to treatments made the difficulty of living with the Covid-19 pandemic even more difficult.

He said: Not being able to have these appointments meant I was in more pain and discomfort than I would normally have.

Before the pandemic I also saw a physio regularly, but I couldnt go there for treatment for the best part of a year.

The delays were quite considerable but thankfully things are beginning to open up more again.

Covid generally was a very isolating experience for most people. Mentally it was tough and not having access to treatments definitely made a hard situation even more difficult.

Previously working as a nanny, Tanya had hoped to start a new job at a nursery when she was diagnosed with Cauda Equina Syndrome in March 2020 after suffering from severe pain.

She had an operation on her back as one of her discs had moved and was crushing her spinal nerve.

Tanya still has issues around going to the bathroom and has to use crutches to get around as she can only walk short distances.

She said that her husband had to give up one of his jobs to help care for her, with their lives having been flipped upside down.

I have not seen my surgeon since my operation because of Covid-19. I struggled to get them to refer me to a Neuropsychologist as I was home and struggling badly with the way I now was, Tanya explained.

I did eventually get one but was by phone only because of Covid, along with physio. I got one closer to home who was my lifesaver as she then told me about all the help that was out there for me and reached out to so many of her colleagues to help me. This was about six months after my condition.

My husband had to give up one of his jobs to help care for me as our whole lives had been flipped upside down and I needed help with everything personally and around the house.

I use crutches around my house and Im in a wheelchair outside as I can only walk a short distance and had to have a lot of adaptions around the house.

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Scots with neurological conditions struggling to access appointments, study finds - STV News

Dubai: A 36-year-old Indian expatriate, who nearly lost his eyesight to a rare condition that affects one in a million each year, had his vision restored thanks to the quick thinking by a Dubai neurologist. Timely diagnosis of Tolosa Hunt Syndrome (THS) helped the neurologist at Medeor Hospital initiate action that cured the patient of the ailment in three days.

In early April 2022, Faiz Muhammad Yusuf, an expatriate working in a company in Dubai, was excited and gearing up for his long-awaited vacation. However, just a few days before his flight, Yusuf, hailing from Chennai, India, experienced a severe headache and fever. This was followed by loss of vision in his left eye.

In addition, Yusuf also developed double vision, drooping of the left eyelid and multiple cranial nerve palsy. Due to extreme pain, he was unable to eat or drink. Yusufs friends rushed him to the Emergency Section of Medeor Hospital, Dubai, on April 2. A consultant ophthalmologist, who examined him, realised the problem had a neurological root and referred him to Dr Anas Abdul Majeed, consultant neurologist at the hospital. Upon detailed examination of the patient, Dr Majeed stumbled upon a rare diagnosis.

Comprehensive screening confirms diagnosis

Dr Majeed told Gulf News: After clinical examination of the patient, I prescribed a brain MRI. This imaging showed a well-defined lesion behind his left eye, which opened up possibilities for different diagnosis. Dr Majeed ordered a lumbar puncture, through which the cerebrospinal fluid of the patient was drawn and examined to rule out grave conditions, including meningitis. Only after following these diagnostic tests, was I able to diagnose that Yusuf suffered from the rare THS based on the diagnostic criteria and detailed investigations.

What is Tolosa Hunt Syndrome?

According to the United States-based National Organisation for Rare Disorders, THS is a rare neurological disorder occurring in one in a million persons a year, impacting the ocular neural nerve, characterised by sharp, stabbing pain in usually one eye, severe headache, accompanied by double vision or loss of vision. If diagnosed in time, it is possible to reverse the condition.

Dr Majeed added: This condition is idiopathic and there are no reasons as to why it occurs. It is not a congenital or genetic disorder and once diagnosed can be treated with steroids for complete recovery. It is important that the patient undergoes a proper treatment protocol to prevent any chances of a relapse.

Quick medical intervention is the key

Dr Majeed swiftly started the medications, including steroids. Yusuf responded well to medications and started showing signs of recovery just two days after being admitted to ICU [Intensive Care Unit]. We administered him IV steroids for three days and he showed significant improvement, Dr Majeed said.

Vision restored

After spending around four days in hospital, Yusuf was discharged and within two days after that, he flew back to India to spend his vacation with his family.

Yusuf, who was grateful to Dr Majeed, thanked him for the timely intervention and for saving his eyesight. I am grateful to God. I am also thankful to Dr Majeed and his team. My pain was unbearable. I could not eat or drink anything. I was unable to see anything. By the time, I reached the hospital, the pain had increased and my health had deteriorated considerably. I could have lost my eyesight had the doctor not done a correct diagnosis and treated me. My family and I will remember him in our prayers for our lifetime.

Challenging case

Dr Majeed added: Yusuf was lucky that his condition was correctly diagnosed as THS is a rare and complicated disease. Timely treatment through vast therapeutic armamentarium and teamwork was crucial to the patients timely recovery. He is advised regular follow-up after recovery.

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Dubai neurologist saves eyesight of patient with timely diagnosis and treatment - Gulf News

Dr. James Galvin, chief of the Division of Cognitive Neurology at the University of Miami Miller School of Medicine, explains the brain disorder afflicting Bruce Willis that has caused him to step away from his acting career.

The entertainment world was shocked Wednesday when Bruce Willis and his ex-wife Demi Moore announced that the Hollywood icon of the Die Hard movie franchise is suffering from aphasia.

Around the world, many people Googled the word to learn what it meant and what the diagnosis would entail for the popular actor moving forward. In a statement on her Instagram account, Moore addressed Willis amazing fans to share that his cognitive abilities have been impacted.

As a result of this and with much consideration, Bruce is stepping away from the career that has meant so much to him, Moore said. This is a really challenging time for our family, and we are so appreciative of your continued love, compassion, and support. The post is signed by Willis current wife Emma, Moore, and his children Rumer, Scout, Tallulah, Mabel, and Evelyn.

Willis, 67, is a Hollywood superstar who has starred in dozens of critically acclaimed films including, Pulp Fiction, The Sixth Sense, and the Die Hard series. According to The New York Times, Willis has received three Golden Globe nominations, capturing one. He also won an Emmy for outstanding lead actor in a drama series for the TV show Moonlighting.

Dr. James Galvin, a professor of neurology at the University of Miami Miller School of Medicine and chief of the Division of Cognitive Neurology, explains aphasia and its treatment.

What is aphasia?

Aphasia is a medical term to describe conditions of disturbance of language (speaking, writing, reading, and comprehension) and is due to damage to the language centers in the brain. Aphasia can be fluent with good production of words, but a loss of the comprehension and understanding of the meaning of the words produced, or non-fluent with relatively preserved comprehension but a great difficulty in language expression such as speaking or writing. The illness can be caused by a focal injury such as a stroke, traumatic injury, or brain infection (encephalitis). In this case, the presentation of aphasia is typically mire acute or sudden. Aphasia can also be caused by more slowly progressing processes such as a brain tumor or a neurodegenerative disease such as Alzheimers disease or frontotemporal degeneration. In particular, a type of frontotemporal degeneration is known as primary progressive aphasia where language problems are the first, and in many cases the only symptoms.

Who is most at risk of contracting this disease?

This depends somewhat on the underlying cause. In the case of a neurodegenerative disease, older age is a strong risk factor. Frontotemporal degeneration, for example, typically begins sometime between the late 40s to mid-60s, while Alzheimers disease more commonly begins at a later age.Tumors and strokes can occur at any age but are more common with increasing age.

Is there a treatment for aphasia? Or, if someone is diagnosed with it, how can they manage the ailment?

This again depends somewhat on the underlying cause. If an underlying cause can be identified, such as a tumor or infection, treatment of the cause may improve symptoms. If due to a stroke or traumatic injury where the lesion is static or non-progressive, speech and language therapy can provide improvements or, at the very least, coping strategies. In the case of neurodegenerative disease, there are few clearly effective options, although some individuals may benefit for a short time from speech therapy. As swallowing difficulties can sometimes accompany language difficulties, it is important to rule this out so to avoid aspiration pneumonia.

What is the difference between simple forgetfulness and symptoms that indicate there is something more serious happeninglike aphasia, dementia, or Alzheimers?

Memory loss is not a part of the normal aging process, although many older adults subjectively report their memory is not as good as it once was. Instead of being truly forgetful, processing speed declines so that it takes longer than usual to recall information. But with time, the information is recalled, and people can benefit from clues or prompts. Progressive changes in memory, language, or other cognitive functions are often a sign of a neurodegenerative disease such as Alzheimers disease or a related dementia such as primary progressive aphasia, frontotemporal degeneration, or Lewy body dementia. Difficulty finding the right words can be an early sign of all of these conditions.

What is the difference between aphasia and dysphasia?

Aphasia is the loss of language, while dysphasia means impaired language. Neurologists often dont use the term dysphasia because it can be confused with dysphagia which means difficulty swallowing.

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Neurology specialist addresses aphasia, the illness affecting Bruce Willis - University of Miami: News@theU

Three experimental blood tests used to identify people in early stages of Alzheimers disease perform differently in Black individuals compared to white individuals, according to a new study from Washington University School of Medicine in St. Louis.

The study showed that a fourth blood test the PrecivityAD test, which is commercially available in the U.S. and Europe through C2N Diagnostics was equally effective at detecting early Alzheimers disease regardless of the race of the person being tested. Since cutoffs between normal and abnormal test scores usually are set based on predominantly white volunteers, tests that perform differently in Black compared to white populations put Black patients at disproportionate risk of misdiagnosis and receiving inappropriate medical care.

The study is published April 21 in the journal Neurology.

Most people are diagnosed with Alzheimers only after they become forgetful and confused. Such cognitive symptoms arise relatively late in the course of the disease, a decade or more after the brain first begins to change. Scientists are working to identify people earlier using blood tests that detect Alzheimers-associated proteins in the blood, also known as biomarkers. But the field of Alzheimers biomarker research is based on data collected from groups of mostly white participants, raising concerns about whether tests based on such biomarkers are equally valid in diverse populations.

When you use a limited study population as, unfortunately, scientists have traditionally done in Alzheimers research and then try to apply the results to everyone, including people of diverse backgrounds, you could exacerbate health inequities, said lead authorSuzanne Schindler, MD, PhD, an associate professor of neurology. My hope is that this paper will help illustrate the need to increase the diversity of participants in Alzheimers studies. My colleagues and I are working to develop a much larger, multicenter study to better evaluate racial differences in Alzheimers-related blood biomarkers. This is a major priority for us.

The study was not designed to find the reason some Alzheimers biomarkers lead to different results in Black individuals compared to white individuals, but the presence of other health conditions could play a role. In this study, Black participants were more likely than white participants to have high blood pressure (67% versus 45%) and diabetes (28% versus 5%). Both conditions are linked to Alzheimers disease and may influence performance of biomarker tests, the researchers said.

The PrecivityAD test uses high-resolution mass spectrometry to measure the ratio of the Alzheimers proteins amyloid beta 42 and amyloid beta 40, as well as apolipoprotein E (APOE), a protein that affects risk for Alzheimers disease. The underlying technology behind the PrecivityAD test was developed at Washington University in the laboratory ofRandall J. Bateman, MD, the Charles F. and Joanne Knight Distinguished Professor of Neurology and a co-author on this paper. C2N, the maker of the PrecivityAD test, is a Washington University startup and is based in St. Louis.

The researchers analyzed the accuracy of the PrecivityAD test and blood tests for two other proteins neurofilament light protein and two forms of the protein tau in 76 pairs of Black and non-Hispanic white participants. The pairs were created by pulling from a pool of volunteers who take part in research studies through Washington Universitys Charles F. and JoanneKnight Alzheimer Disease Research Center(Knight ADRC), and were matched on age, gender, cognitive status and presence of the high-risk genetic variant ofAPOE.More than 90% of individuals had no cognitive impairment.

The researchers determined whether each individual had the brain changes of Alzheimers disease using brain scans, analyzing the cerebrospinal fluid that surrounds the brain and spinal cord, or both. High levels of amyloid plaques found on brain scans or specific changes in the cerebrospinal fluid are both considered gold-standard evidence of Alzheimers.

Only the PrecivityAD test accurately classified people by Alzheimers status regardless of self-identified race. The other three blood tests were not as accurate at classifying people by Alzheimers status. Worse, they also performed differently in Black individuals compared to white individuals.

The fact these risk models have not been tested in a lot of populations makes me wary, because Alzheimers is a global disease, said co-author Thomas K. Karikari, PhD, an assistant professor in the Department of Psychiatry and Neurochemistry at the University of Gothenburg in Gothenburg, Sweden. Karikari is originally from Ghana. For example,APOEis a very good predictor of Alzheimers disease in people of European ancestry, but for people of non-European ancestry, it may not be a good predictor. We have to study these risk models in a wide variety of people to understand where does it work, where does it not work, and what are the factors that affect the performance of these models.

Race norming, or calibrating tests separately for each race, is not a satisfactory solution to the problem of differences in biomarkers across racial groups, Schindler and Karikari said. Such a practice can create or worsen racial disparities. For example, until 2021 the NFL routinely used race-normed cognitive tests to evaluate former players for cognitive impairments linked to injuries sustained on the field. Such tests consistently underestimated the degree of impairment suffered by Black players, making it difficult for them to obtain appropriate compensation. Washington University physicians do not use race-norming when assessing cognitive function, saidJohn C. Morris, MD, the Harvey A. and Dorismae Hacker Friedman Distinguished Professor of Neurology. Morris is the director of the Knight ADRC and a co-author on the paper.

Rather than trying to adjust for race in some way, it would be better to use tests that perform equally well in all individuals, Schindler said. Alternatively, we can try to understand the underlying factors that create these apparent racial differences and adjust for those underlying factors rather than race. What we dont want to do is to use these tests without evaluating their performance in diverse groups, because then we would fail in our duty to provide the best possible care to all.

Experimental study

People

Effect of race on prediction of brain amyloidosis by plasma A42/A40, phosphorylated tau, and neurofilament light.

21-Apr-2022

S.E. Schindler has received data on behalf of Washington University from C2N Diagnostics at no cost; T.K. Karikari reports no disclosures relevant to the manuscript; N.J. Ashton reports no disclosures relevant to the manuscript; R.L. Henson reports no disclosures relevant to the manuscript; K.E. Yarasheski is an employee of C2N Diagnostics, which offers the PrecivityADTM test described in this paper; T. West is an employee of C2N Diagnostics, which offers the PrecivityADTM test described in this paper; M.R. Meyer is an employee of C2N Diagnostics, which offers the PrecivityADTM test described in this paper; K.M. Kirmess is an employee of C2N Diagnostics, which offers the PrecivityADTM test described in this paper; Y. Li reports no disclosures relevant to the manuscript; B. Saef reports no disclosures relevant to the manuscript; K.L. Moulder reports no disclosures relevant to the manuscript; D. Bradford reports no disclosures relevant to the manuscript; A.M. Fagan has received research funding from Biogen, Centene, Fujirebio and Roche Diagnostics. She is a member of the scientific advisory boards for Roche Diagnostics, Genentech and Diadem. She consults for DiamiR and Seimens Healthcare Diagnostics Inc.; B.A. Gordon reports no disclosures relevant to the manuscript; T.L.S. Benzinger has investigator-initiated research funding from the NIH, the Alzheimers Association, the Barnes-Jewish Hospital Foundation and Avid Radiopharmaceuticals (a wholly owned subsidiary of Eli Lilly). She participates as a site investigator in clinical trials sponsored by Avid Radiopharmaceuticals, Eli Lilly, Biogen, Eisai, Jaansen, and Roche. She serves as an unpaid consultant to Eisai and Siemens. She is on the Speakers Bureau for Biogen; J. Balls-Berry is a member of the patient advisory board and receives financial support for Dartmouth University project Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings (UPFRONT; NCT03985449); R.J. Bateman co-founded C2N Diagnostics. Washington University and Dr. Bateman have equity ownership interest in C2N Diagnostics and receive royalty income based on technology (stable isotope labeling kinetics and blood plasma assay) licensed by Washington University to C2N Diagnostics. He receives income from C2N Diagnostics for serving on the scientific advisory board. Washington University, with Dr. Bateman as coinventor, have submitted the US provisional patent application Plasma Based Methods for Detecting CNS Amyloid Deposition. He consults for Roche, Genentech, AbbVie, Pfizer, Boehringer-Ingelheim, and Merck; C. Xiong consults for Diadem; H. Zetterberg has served at scientific advisory boards and/or as a consultant for Alector, Eisai, Denali, Roche Diagnostics, Wave, Samumed, Siemens Healthineers, Pinteon Therapeutics, Nervgen, AZTherapies, CogRx and Red Abbey Labs, has given lectures in symposia sponsored by Cellectricon, Fujirebio, Alzecure and Biogen, and is a co-founder of Brain Biomarker Solutions in Gothenburg AB (BBS), which is a part of the GU Ventures Incubator Program; K. Blennow has served as a consultant, at advisory boards, or at data monitoring committees for Abcam, Axon, Biogen, JOMDD/Shimadzu. Julius Clinical, Lilly, MagQu, Novartis, Prothena, Roche Diagnostics, and Siemens Healthineers, and is a co-founder of Brain Biomarker Solutions in Gothenburg AB (BBS), which is a part of the GU Ventures Incubator Program; J.C. Morris, MD is the Chair of the Research Strategy Council of the Cure Alzheimers Fund.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Race of people given Alzheimer's blood tests may affect interpretation of results - EurekAlert

EMBARGOED FOR RELEASE UNTIL 4 P.M. ET, THURSDAY, MARCH 31, 2022

Newswise MINNEAPOLIS A small, preliminary study of an investigational new drug being studied for mild cognitive impairment and mild dementia associated with Alzheimers disease suggests it is safe and may be associated with improvements in executive function, thinking and memory skills. The study is released today, March 31, 2022, and will be presented at the American Academy of Neurologys 74th Annual Meeting being held in person in Seattle, April 2 to 7, 2022 and virtually, April 24 to 26, 2022. The drug, called SAGE-718, is also in clinical trials for the treatment of cognitive impairment associated with Parkinsons disease and Huntingtons disease.

Cognitive impairment is often one of the earliest signs of Alzheimers disease, can be very difficult for patients and their families, and represents an area of great unmet medical need, said study author Aaron Koenig, MD, of Sage Therapeutics in Cambridge, Mass., the maker of the investigational drug. These results support further research with larger numbers of people to determine whether this therapy is safe and effective in treating cognitive impairment in Alzheimers disease and related disorders and in improving how well people can function independently in their everyday lives.

The study involved 26 people with an average age of 67. They had an average score of 20.7 points on a common cognitive test, indicating cognitive performance consistent with mild cognitive impairment or mild dementia. The participants took SAGE-718 daily for two weeks and were then followed for another two weeks. They completed tests of thinking and memory at the beginning of the study, at the end of treatment, and after one month. Both the participants and researchers knew that SAGE-718 was being administered.

The study was designed mainly to gather data on the drugs safety. There were no serious side effects of the drug. Five people had mild or moderate side effects believed to be related to the drug, such as headache or constipation.

After one month, the participants scores on the cognitive test had improved by an average of 2.3 points, to 22.8 points.

Koenig said some participants also had improvement in assessments of how well they were able to complete their daily activities, especially in complex activities such as using a computer, carrying out household chores, and managing their medications. This coincided with consistent improvement on multiple tests of executive functioning that were administered during the trial.

Koenig said, If replicated in future studies, such improvements suggest that this drug may eventually provide meaningful benefits to people in their everyday lives.

SAGE-718 is a type of drug called a positive allosteric modulator of N-methyl-D-aspartate (NMDA) receptors.

The studys limitations include its small size and that participants and researchers knew that the drug was being administered, which could lead to bias.

The study was supported by Sage Therapeutics, Inc.

Learn more about brain health at BrainandLife.org, home of the American Academy of Neurologys free patient and caregiver magazine focused on the intersection of neurologic disease and brain health. Follow Brain & Life on Facebook, Twitter and Instagram.

When posting to social media channels about this research, we encourage you to use the American Academy of Neurologys Annual Meeting hashtag #AANAM.

The American Academy of Neurology is the worlds largest association of neurologists and neuroscience professionals, with over 38,000 members. The AAN is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimers disease, stroke, migraine, multiple sclerosis, concussion, Parkinsons disease and epilepsy.

For more information about the American Academy of Neurology, visit AAN.com or find us on Facebook, Twitter, Instagram, LinkedIn and YouTube.

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Preliminary Study: Drug May Be Safe in Those with Mild Cognitive Impairment, Mild Dementia - Newswise

The medical professionals say these teens are developing tics after watching videos of those with Tourette's Syndrome.

HARRISBURG, Pa. With its popularity growing since its launch in the U.S. in 2018, Tik-Tok has become a sensation for its users promoting creativity and entertainment.

Doctors across the globe say they are seeing complications in movement from teenage girls as a greater number are seeking treatment for tics. They say the young teens are developing the tics after watching Tik-Tok videos of creators who have Tourette's syndrome.

One might ask, what is the difference?

"A tic is a complicated movement that's stored in the center part of the brain that you feel this pressure that pushes movement out and you can try to hold it back but it gets stronger and stronger often when you do until it forces it's way out," said Dr. Jeremy Timothy, a pediatric neurologist for WellSpan Health.

Timothy says Tourette's syndrome, on the other hand, is a type of tic disorder, where people have multiple tics persistently over a course of time. This type of disorder usually arises in children, but Timothy says he's seen cases in teens now.

Research has pointed out teen girls who developed these tics during the pandemic had pre-existing mental health issues making them prone to other disorders.

Dr. Melissa Brown, a psychologist for UPMC, says stress and anxiety toppled by the pandemic are a "perfect storm" to create issues like these.

"The pandemic hit, placing a lot of social constraints on our teens, and girls tend to be very social and integrated into their social circles," she said.

Timothy says it's important for parents to speak to their children's doctors and if they happened to have tics, seek out treatments. Some of these include medications or CBIT -- Comprehensive Behavioral Intervention for Tics.

This is a therapy where one learns tricks to substitute different movements for tics that is less noticeable or shift gears in your mind from something that may trigger tics.

Another way for parents to help is to be more engaged and present in their child's life.

"Engaging in conversations, getting more physical activity, making sure they're sleeping well-our teens do need a lot of sleep," said Brown. "Of course, watch their diets and checking out what they're consuming."

Tik-Tok has responded to the issue publically, stating people with Tourette's Syndrome use the app "to express themselves authentically, find community and fight stigma."

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Doctors say heavy Tik-Tok usage is causing neurological health complications - WPMT FOX 43

A female in her 70s experienced weakness in her legs, trouble swallowing, and several falls. When she fell and couldnt get up, she called an ambulance and was transported to a local hospital.

Physicians at the hospital consulted Duke Healths neurology experts, who suggested a diagnosis of Guillain-Barre syndrome. The local hospital initiated a standard treatment for Guillain Barreintravenous immunoglobulin (IVIG)but the patient did not respond after two treatments. Because of a rapid deterioration of muscular function, she was transferred to Duke Hospital overnight. The deterioration ascended from her feet and began to compromise her pharyngeal and respiratory muscles.

When I arrived at the hospital, she was decompensating quickly. She was taken to the neurological ICU where she was intubated and placed on a ventilator, says Jordan L. Mayberry, MD, a neuromuscular specialist on duty that day. Mayberry was concerned by her lack of response to IVIG. To head off any further deterioration, he made the fast decision to change to a treatment the local hospital did not offer.

What therapy offered at Duke but few other North Carolina hospitals did Mayberry institute for a better chance at speeding the patients recovery?

Read more here:
Innovative therapy reverses neuropathology in elderly woman | Duke Department of Neurology - Duke Department of Neurology

NASHVILLE, Tenn.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced they will give one oral presentation and present one poster at the 2022 American Academy of Neurology Annual Meeting, taking place on April 2-7, 2022 in Seattle, Washington.

We look forward to participating at AAN this year, where we will give our first, in-person oral presentation of the ASPEN-1 Phase 3 clinical trial results, and also present new data from the ASPEN-OLS Phase 3 open-label, long-term safety study of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia, said Mark J. Foley, Chief Executive Officer of Revance. As we seek to help patients with this debilitating condition achieve long-lasting symptom relief, the important data from our ASPEN-1 Phase 3 program continues to show DaxibotulinumtoxinA for Injections long duration of effect and encouraging safety profile. The pivotal ASPEN-1 trial demonstrated two efficacious and well-tolerated dose levels of DaxibotulinumtoxinA for Injection compared to placebo, with consistent patient and clinician reports of improvement and treatment satisfaction. Results from the ASPEN-OLS study reinforce the long-term safety and efficacy of our pivotal study with up to four repeat doses.

Oral Presentation:

Poster:

The above abstracts are available online via the AAN website at http://www.aan.com.

About Revance

Revance is a commercial stage biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation, long-acting neuromodulator product, DaxibotulinumtoxinA for Injection. Revance has successfully completed Phase 3 clinical programs for DaxibotulinumtoxinA for Injection in glabellar (frown) lines, for which the company is currently pursuing U.S. regulatory approval, and in cervical dystonia. Revance is also evaluating DaxibotulinumtoxinA for Injection in adult upper limb spasticity. Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the OPUL Relational Commerce Platform. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX, which if approved, would be the first and only generic biosimilar to Botox and Botox Cosmetic. For more information or to join our team visit us at http://www.revance.com.

Revance Therapeutics and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

Resilient Hyaluronic Acid and RHA are trademarks of TEOXANE SA.

BOTOX is a registered trademark of Allergan, Inc.

Forward-Looking Statements

Any statements in this press release that are not statements of historical fact, including statements related to the potential benefits, efficacy and duration of DaxibotulinumtoxinA for Injection and our development of a biosimilar to BOTOX with our partner, Viatris, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals; our ability to remediate deficiencies identified by the FDA and obtain FDA approval of the BLA for DaxibotulinumtoxinA for Injection for glabellar lines, including as a result of observations made by the FDA during the site inspection or other reasons; our ability to obtain funding for our operations; the timing of capital expenditures; the accuracy of our estimates regarding expenses, future revenues, capital requirements, our financial performance and the economics of DaxibotulinumtoxinA for Injection, the RHA Collection of dermal fillers and OPUL; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products and services, the aesthetics market, commercialization efforts, business operations, regulatory meetings, inspections and approvals, clinical trials and other aspects of our business and on the market; our ability and the ability of our partners to manufacture supplies for our product candidates and to acquire supplies of the RHA Collection of dermal fillers; the uncertain clinical development process, the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, commercial acceptance, market, competition and/or size and growth potential of the RHA Collection of dermal fillers, OPUL and our drug product candidates, if approved; our ability to continue to successfully commercialize the RHA Collection of dermal fillers and OPUL and our ability to successfully commercialize DaxibotulinumtoxinA for Injection, if approved, and the timing and cost of commercialization activities; the proper training and administration of our products by physicians and medical staff; our ability to expand sales and marketing capabilities; the status of commercial collaborations; changes in and failures to comply with privacy and data protection laws; our ability to effectively manage our expanded operations in connection with the acquisition of Hint, Inc; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; the cost and our ability to defend ourselves in product liability, intellectual property, class action or other lawsuits; the volatility of our stock price; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" in our Form 10-K, filed with the SEC on February 28, 2022. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

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Revance to Present New Clinical Data on DaxibotulinumtoxinA for Injection from the ASPEN Phase 3 Program at the 2022 American Academy of Neurology...

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Horizon Therapeutics Highlights Presentation During Poster Presentation At American Academy Of Neurology On Co.'s UPLIZNA - Benzinga

SAN DIEGO, CA, March 31, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Sigyn Therapeutics, Inc. (OTC Markets:SIGY), a medical technology company focused on the treatment of pathogen-associated conditions that induce sepsis and other life-threatening disorders, today announced the appointment of Ajay Verma, M.D., Ph.D.to its Scientific Advisory Board.

Dr. Verma is a recognized thought leader in the field of neurology. His extensive clinical experience and resulting insights are anticipated to contribute to the continued advancement of Sigyn Therapy. Sigyn Therapy is an extracorporeal blood purification technology being advanced to treat life-threatening inflammatory disorders.

Dr. Verma is a neurologist, neuroscientist, drug developer, inventor, and biotech science advisor. Dr. Verma most recently headed R&D efforts at Yumanity Therapeutics, developing drugs against novel targets for treating neurodegenerative diseases. Prior to that he was the EVP of Research and Experimental Medicine at Codiak Biosciences. He has also served as CMO at United Neuroscience (now called Vaxxinity), VP of Neurology at Biogen and Novartis, and Director of Neuroscience Experimental Medicine at Merck. His drug development experience spans small molecule, peptide/protein, antibody, oligonucleotide, vaccine, and exosome drug platforms. He has largely focused on translational and early clinical development in neurology indications using precision drug development approaches that leverage biomarkers and experimental medicine paradigms. Prior to his Biopharma career, Dr. Verma was Professor of Neurology at the Uniformed Services University of the Health Sciences. He also worked as a staff neurologist at the Walter Reed Army Medical Center for 11 years after completing his neurology residency there. He received his M.D. and Ph.D. from Johns Hopkins University, where he trained in the laboratory of Dr. Solomon Snyder. He received his B.S. in Zoology from the University of Maryland.

About Sigyn Therapeutics

Sigyn Therapeutics is a medical technology company focused on the treatment of pathogen-associated conditions that precipitate sepsis, the leading cause of hospital deaths worldwide. Sigyn Therapy is a multi-function blood purification technology that extracts pathogen sources of life-threatening inflammation in concert with the broad-spectrum elimination of inflammatory mediators from the bloodstream.

Beyond establishing a novel strategy to combat sepsis, candidate treatment indications for Sigyn Therapy include, but are not limited to; emerging pandemic threats, hepatic encephalopathy, bridge to liver transplant, and community-acquired pneumonia (CAP), which is a leading cause of death among infectious diseases, the leading cause of death in children under five years of age, and a catalyst for approximately 50% of sepsis and septic shock cases.

To learn more, visit http://www.SigynTherapeutics.com

Cautionary Note Regarding Forward-Looking Statements

This information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. (Sigyn) that involve substantial risks and uncertainties. All statements contained in this summary are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Sigyn's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences may include, without limitation, the Company's ability to clinically advance Sigyn Therapy in human studies required for market clearance, the Company's ability to manufacture Sigyn Therapy, the Company's ability to raise capital resources, and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this report speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

Contacts:

Stephen Kilmer

Sigyn Therapeutics, Inc.

Investor Relations

(646) 274-3580

stephen@sigyntherapeutics.com

Media Contacts:

Russo Partners, LLC

David Schull

(212) 845-4271

David.Schull@russopartnersllc.com

Nic Johnson

(212) 845-4242

Nic.Johnson@russopartnersllc.com

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Sigyn Therapeutics Appoints Ajay Verma, MD, Ph.D. to its Scientific Advisory Board - GlobeNewswire

Research Nester published a report titled In-Vitro Diagnostics for Cardiology and Neurology Market: Global Demand Analysis & Opportunity Outlook 2031 which delivers detailed overview of the global in-vitro diagnostics for cardiology and neurology market in terms of market segmentation by product type, technology, end user, and by region.

Further, for the in-depth analysis, the report encompasses the industry growth indicators, restraints, supply and demand risk, along with detailed discussion on current and future market trends that are associated with the growth of the market.

Theglobal in-vitro diagnostics for cardiology and neurology marketis estimated to occupy a sizeable revenue by growing at a CAGR of ~6% during the forecast period, i.e., 2022 2031, ascribing to the rising adoption of point-of-care testing devices to boost the demand for in-vitro diagnostics tests. Along with this, growing prevalence of chronic disorders across the globe, and escalating awareness levels associated with disease diagnosis, and rapidly increasing geriatric population are also expected to accelerate the growth of the market in the upcoming years.

The market is segmented by product type, technology and end user. Based on type, the reagents & consumables segment is anticipated to acquire the largest share during the forecast period on the back of the high precision and accurate diagnosis provided by recently developed reagents & consumables. Additionally, by end user, the hospitals segment is projected to grab the largest share over the forecast period attributing to the tremendous amount of diagnostic testing required to support a clinical decision for enhancing patient discovery, which is only possible in a hospital facility.

For More Information About This Report Visit:https://www.researchnester.com/sample-request-3849

Geographically, the global in-vitro diagnostics for cardiology and neurology market is segmented into five major regions, namely North America, Europe, Latin America, Asia Pacific, and the Middle East & Africa. Asia Pacific is evaluated to witness noteworthy growth in the market during the forecast period. This can be attributed to the rising investments by healthcare providers for improving the diagnostics infrastructure in the region. Moreover, the market in North America is assessed to acquire the largest share over the forecast period ascribing to the high healthcare spending, and strong presence of market players in the region.

The research is global in nature and covers detailed analysis on the market in North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC [Finland, Sweden, Norway, Denmark], Poland, Turkey, Russia, Rest of Europe), Latin America (Brazil, Mexico, Argentina, Rest of Latin America), Asia-Pacific (China, India, Japan, South Korea, Indonesia, Singapore, Malaysia, Australia, New Zealand, Rest of Asia-Pacific), Middle East and Africa (Israel, GCC [Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman], North Africa, South Africa, Rest of Middle East and Africa). In addition, analysis comprising market size, Y-O-Y growth & opportunity analysis, market players competitive study, investment opportunities, demand for future outlook etc. has also been covered and displayed in the research report.

Growing Occurrence of Chronic Disorders Around the World to Bolster Market Growth

Since the last few years, the prevalence of several cardiovascular and neurological diseases is increasing significantly. This is resulting in the rise in awareness regarding early diagnosis among the population and an increase in routine diagnosis, which in turn is anticipated to boost the demand for advanced in-vitro diagnostics products in the near future.

However, the expensiveness of in-vitro diagnostics instruments is expected to operate as key restraint to the growth of the global in-vitro diagnostics for cardiology and neurology market over the forecast period.

This report also provides the existing competitive scenario of some of the key players of the global in-vitro diagnostics for cardiology and neurology market which includes company profiling of Thermo Fisher Scientific Inc., F. Hoffman-La Roche Ltd, Sysmex Corporation, Siemens AG, Becton, Dickinson, and Company, DiaSorin S.p.A., Quest Diagnostics, Inc., Bio-Rad Laboratories, Inc., Abbott Laboratories, Danaher Corporation, and others. The profiling enfolds key information of the companies which encompasses business overview, products and services, key financials and recent news and developments. On the whole, the report depicts detailed overview of the global in-vitro diagnostics for cardiology and neurology market that will help industry consultants, equipment manufacturers, existing players searching for expansion opportunities, new players searching possibilities and other stakeholders to align their market centric strategies according to the ongoing and expected trends in the future.

Get a Sample Copy Of This Report With Graphs and Charts:https://www.researchnester.com/sample-request-3849

Research Nester is a one-stop service provider, leading in strategic market research and consulting with an unbiased and unparalleled approach towards helping global industrial players, conglomerates and executives to make wise decisions for their future investment and expansion by providing them qualitative market insights and strategies while avoiding future uncertainties. We believe in honesty and sheer hard work that we trust is reflected in our work ethics. Our vision is not just limited to gain the trust of our clients but also to be equally respected by our employees and being appreciated by the competitors.

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Global In-Vitro Diagnostics For Cardiology And Neurology Market Driving Factors, Industry Growth, And Forecast To 2031 ChattTenn Sports - ChattTenn...

SYRACUSE, N.Y. (WSYR-TV) Central New York has the highest population of patients with Multiple Sclerosis (MS) in the nation. Doctors have been speculating why for years, and it may be getting worse.

A neurologist at St. Josephs Health is concerned about the trend hes seen throughout the pandemic.

Dr. Fahed Saada recently treated a 24-year-old man. His brain and spine were riddled with lesions. Hes in the early stages of MS and joins a growing list of Saadas patients, adding to a trend no neurologist wants to see.

Ive never seen so many acute Multiple Sclerosis cases over the years compared to this past year and I dont know why.

Saada says other viruses can increase our risk, but it will be years before we learn COVID-19s contributions, if any. In the meantime, more people are getting sick.

Early treatment can give patients some improvement, but over time, MS progresses.

The disease disrupts the brains ability to send messages to the rest of the body. Theres no cure, and eventually, it causes permanent damage to the nerves.

These lesions, if theyre not treated appropriately and quickly, they become what we call black holes in the brain.

Its hard to stop an uptick in cases when doctors dont know whats causing it.

However, neurologists do know that places north of the equator are at a higher risk because patients with MS have low vitamin D levels.

Doctors also know we here in Central New York dont get a lot of sunlight in the winter.

For now, though, Saada says its a medical mystery doctors desperately want to solve.

Saada says a vitamin D supplement may help boost your prevention, but you should always talk to your doctor before making any changes to your medication and supplements.

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Wellness Wednesday: neurologist concerned about Multiple Sclerosis trend hes seen throughout the pandemic - WSYR

Whether stress-induced or genetic, headaches are a common condition that can affect anyone. This includes neurologists AKA the specialists who treat headache disorders.

Headache is any pain affecting the head, upper face or upper neck. Headaches are called primary when they arise from biological changes within the brain itself, Robert Kaniecki, the director of the UPMC Headache Center in Pittsburgh, told HuffPost. These include migraine headaches, tension-type headaches, and cluster headaches.

Migraine-induced headaches cause additional symptoms such as nausea, sensitivity to light and noise, fatigue, visual disturbances and more. People may also experience secondary headaches if there is another underlying illness or cause for the headache, Kaniecki said.

Worldwide, headache disorders are considered one of the most common yet under-treated disorders of the nervous system. Additionally, a 2018 study found that one in six people in the U.S. reported having a migraine or severe headache over a three-month period.

HuffPost spoke to neurologists about the things they personally do when experiencing a headache, and why these go-to strategies work.

Find a calming space.

Creating a quiet and relaxing environment is often the first step some neurologists take to alleviate headache pain.

If I have a headache, I rest or lie down for as long as I can, and it doesnt depend on the time of day, said Faye Begeti, a neurology doctor and neuroscientist in the U.K. With migraines in particular, people usually find that they have to lie down in a quiet, dark room.

Distract your mind.

With busy schedules and responsibilities, taking a quick siesta isnt always feasible. Rami Burstein, a professor of anesthesia and neuroscience at Harvard Medical School, explained that he tends to utilize relaxing distractions when he cant power nap in the workplace.

As contrary as it may sound, walking can be helpful and reading, Burstein said.

Figure out your triggers.

Understanding your headache triggers can serve as both a preventative and in-the-moment approach to address pain.

Most of my migraine attacks are visually triggered or are triggered when I am ambivalent or worried about a decision or situation. The latter is a bit harder to control, but its fascinating to recognize, said Jan Lewis Brandes, the director and founder of the Nashville Neuroscience Group. Red wine can be a trigger for me, so I am careful about not having more than a few ounces.

Additionally, a common headache trigger is sleep disturbances. Theres a misconception that headaches are primarily caused by sleep deprivation, but Begeti explained that sticking to a consistent sleep schedule may be more important than the amount of sleep you get every night.

This is something that I didnt know when I was at university, so I would reliably have a headache every single Saturday after staying up late the day before, and sleeping in on the weekend, Begeti said.

Westend61 via Getty Images

Get hydrated ASAP.

Many neurologists pay closer attention to what they drink when experiencing headache pain. As simple as it sounds, water is your best friend when you have a headache or migraine.

Kristina Lopez, an assistant professor at the West Virginia University Rockefeller Neuroscience Institute and headache specialist, said that her headaches are typically a signifier that she needs to up her hydration. While Lopez explained that researchers arent quite sure why drinking water eases headache pain (there are a number of theories), its a cheap and safe preventative and as-needed treatment strategy.

I finally took my own advice and started getting a consistent eight hours of sleep and drinking more water, Lopez said. Its wild how much better I feel.

Try drinking a little coffee, too.

Though it may seem counterintuitive, caffeine can actually be a remedy for headaches. Brandes said that drinking a cup of coffee is the first step she takes when combatting a migraine attack, followed by drinking a glass of water and taking medication.

Caffeine causes blood vessels to narrow and restricts blood flow around the brain, which can relieve pain. However, moderation is key: Consuming caffeine on the regular may have the opposite effect, leading to withdrawal headaches if you suddenly stop drinking your morning espresso or green tea.

Eat smaller meals throughout the day.

Interestingly, another personal tip from Kanieki is to break snacks and meals into five to six portions throughout the day.

This is because low blood sugar may exacerbate headache pain, along with migraine symptoms. Try swapping up your meal times or breaking down bigger meals into smaller parts that you eat intermittently and see if it helps.

Take pain relievers when necessary.

Depending on the severity of her headache, Begeti will take over-the-counter pain medication such as non-steroidal anti-inflammatory drugs (aka NSAIDs) or acetaminophen. However, be sure to keep track of the amount of pain relievers you take: Begeti noted that she limits her monthly intake of over-the-counter pain medication to under 10 days a month to avoid medication-overuse headaches.

If you are experiencing more severe pain or symptoms, it may be worth a trip to the neurologist to see if you could benefit from prescription medication.

I get migraine attacks and will take a triptan an as-needed migraine pain medication and a nausea medication when I feel an episode coming on, Lopez said.

Remember that some factors are outside of your control.

While some things can help you prevent headache pain, its important to note that not every headache can be linked to lifestyle or environmental factors.

Sometimes there are no notable triggers to headaches, Begeti said. A big part of why people get headaches is due to genetics, and I see headaches that run in families.

Headache pain can range from mild to debilitating. Trying neurologist-approved strategies until you find what specifically works for you may help to alleviate your pain in the long run. Establishing a unique, at-home routine is vital to treating these conditions effectively.

Its important to listen to your body. I find that a headache may resolve if I do that and it certainly prevents it from getting worse, Begeti said.

Read this article:
8 Things Neurologists Do When They Have A Headache - HuffPost

This article was originally published here

Disabil Rehabil. 2022 Jan 27:1-32. doi: 10.1080/09638288.2022.2028911. Online ahead of print.

ABSTRACT

PURPOSE: Peer-based interventions are increasingly popular and cost-effective therapeutic opportunities to support others experiencing similar life circumstances. However, little is known about the similarities and differences among peer-based interventions and their outcomes for people with neurological conditions. This scoping review aims to describe and compare the characteristics of existing peer-based interventions for adults with common neurological conditions.

MATERIALS AND METHODS: We searched MEDLINE, CINAHL, PsychInfo, and Embase for research on peer-based interventions for individuals with brain injury, Parkinsons, multiple sclerosis, spinal cord injury, and stroke up to June 2019. The search was updated in March 2021. Fifty-three of 2472 articles found were included.

RESULTS: Characteristics of peer-based intervention for this population vary significantly. They include individual and group-based formats delivered in-person, by telephone, or online. Content varied from structured education to tailored approaches. Participant outcomes included improved health, confidence, and self-management skills; however, these varied based on the intervention model.

CONCLUSION: Various peer-based interventions exist, each with its own definition of what it means to be a peer. Research using rigorous methodology is needed to determine the most effective interventions. Clear definitions of each program component are needed to better understand the outcomes and mechanism of action within each intervention.IMPLICATIONS FOR REHABILITATIONRehabilitation services can draw on various peer support interventions to add experiential knowledge and support based on shared experience to enhance outcomes.Fulfilling the role of peer mentor may be beneficial and could be encouraged as part of the rehabilitation process for people with SCI, TBI, Stroke, PD, or MS.In planning peer-based interventions for TBI, Stroke, SCI, PD, and MS populations, it is important to clearly define intervention components and evaluate outcomes to measure the impact of the intervention.

PMID:35085058 | DOI:10.1080/09638288.2022.2028911

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Characteristics of peer-based interventions for individuals with neurological conditions: a scoping review - DocWire News

Our search found 37 bedside clinical tests or groups of tests for motor FND (functional weakness and functional movement disorder) that had some formal validation (table 2). Sample size varied between 8 and 107 patients with FND. Most investigations of positive signs were conducted in a single study or a small number of studies (maximum five for the Hoover sign), allowing for the calculation of pooled specificity and sensitivity by merging data from different studies. Five studies reported on the inter-rater reliability of positive signs.

Overall, the specificities of validated signs are high, ranging from 64% to 100%; however, the sensitivities are lower, ranging from 9% to 100%. Inter-rater reliability of these signs is overall good to excellent (defined as values: <0.2 poor/0.21-0.4 fair/0.41-0.6 moderate/0.61-0.8 good/>0.8 excellent).

General signs common to all FND presentations are: variability of the symptom, which can be observed during history taking and examination, and effortful or grimacing expression while following the examiners instructions during examination. If suspecting a functional movement disorder, test oculomotor function to show abnormal eye movements and in particular convergence spasm,100 even if the patient did not endorse this as a concern during history taking.

When assessing gait, look for typical positive signs such as monoplegic leg dragging, excessive visible effort (huffing and puffing sign),50 falling toward support (chair nearby, table, wall), excessive slowness, hesitation or caution, non-economic posture (for example knee flexed), and knee buckling (sudden loss of tone at each step).101 Asking a patient with severe gait disorder to propel a chair while sitting on it will show improvement in FND.51

When assessing hemifacial spasm, look for typical signs such as long contraction of more than three seconds, lip pulling (tonic deviation of the lip, often the lower one) sometimes with platysma contraction, and lack of other Babinski sign for hemifacial spasm (other Babinski sign=eyebrow elevation on the side of the spasm).102 Positive signs for functional orofacial movements in comparison with tardive dyskinesia are: lack of chewing movements, lack of self-biting, lingual movements without mouth movements, and abnormal speech.45 A large case series (61 patients) that focused on facial functional movement103 reported involvement of the lip as the most frequent (60.7%, with the lip pulling feature).

When assessing movements of the trunk, look for the typical positive sign of asymmetry in strength of the sterno-cleido-mastoid muscle.53 A functional Romberg sign is described as large movements of imbalance with sudden steps and no falls and improvement with cognitive distraction or numbers drawn on the back.48

When assessing episodes of cataplexy (brief, symmetrical loss of muscle tone with retained consciousness precipitated by strong emotions) look for positive signs54 such as lack of sudden facial expression change, facial jerks or grimaces, postural dyscontrol (head drop, trunk fall), in addition to preserved tendon reflexes (which typically disappear during cataplexy associated with narcolepsy).

When assessing upper arm weakness, look for discordance or inconsistency in strength (at different instances during the examination), as well as a give-way/collapsing pattern, drift without pronation, and/or co-contractions of agonist and antagonist muscles preventing movement of the tested joint. As a cautionary note, give-way/collapsing pattern of weakness is common in patients with pain limited weakness (and pain limited weakness should not be mistaken for functional limb weakness).104 In cases of complete hand plegia, involuntary abduction of the fifth finger can be seen when the patient is asked to do a forced abduction against the examiners resistance on the healthy hand.58 The flex-ext sign, which is the equivalent of the Hoover sign,105 can be elicited as follows: the involuntary flexion of the arm at the elbow that occurs when the patient focuses on extending the healthy elbow against the examiners resistance is better than the voluntary flexion.59

When assessing lower limb weakness, also look for discordance/inconsistence, give-way/collapsing weakness, co-contractions, and the Hoover sign.61 The classical way to describe a positive Hoover sign is when the involuntary hip extension (when the patient focuses on flexing the healthy leg against the examiners resistance) is stronger than the voluntary hip extension. A similar pattern can be found during leg abduction60: when the patient is asked to do a forced abduction with both legs against the examiners resistance, the weak leg will have a stronger involuntary abduction than when the voluntary abduction is tested. In patients with severe unilateral leg weakness, positioning passively the leg in flexion with the soles on the bed (spinal injury test)62 shows a discordance in strength as the weak leg will not fall on the side, as expected in complete weakness.

When assessing tremor, typical signs are distractibility, entrainment, and increase in amplitude with weight load on the wrists. In addition, look for variability in amplitude, frequency, and direction of tremor.63 A whack a mole sign can be seen106: when the limb affected by tremor is immobilized by the examiner, the tremor appears in another body segment (head, trunk, other arm, or legs).

No validated clinical signs are available for assessing dystonia, but a pattern of adult sudden onset fixed dystonia (typically clenched fist sparing thumb and index finger107) or equinovarus foot is suggestive of functional dystonia.108 Associated prominent pain and other FND signs can help support the diagnosis.109

When assessing tics, no validated signs are available but clinical clues can help identify functional tics110111: lack of premonitory urge and inability to suppress the movement, female preponderance, additional FND symptoms, lack of response to anti-tic medication, and absence of family history. In functional tics, the cranial region is less affected, the type of tic is often blocking (ie, interferes with voluntary action) and pali, echo, and copro phenomenon are less common.

Overall, the evidence for rule-in motor signs shows very high specificity, which advocates for their routine use in clinical practice. A range of educational pictorial and video libraries illustrate many of these signs.2101102112113 Too much emphasis on a single sign, however, can lead to false positives. In a cohort of 190 patients diagnosed with a neurological disorder, 37 (20%) had at least one positive functional neurological sign.91 Interestingly, regression analysis showed that this 20% of the cohort had typical risk factors known in patients with FND, suggesting that the presence of positive signs in this subgroup could either be false positives or indicate the presence of an FND comorbidity. Keep in mind the possibility that the patient has both FND and another neurological disorder: recent reports describe functional neurological signs in a subset of patients with Parkinsons disease114115 or multiple sclerosis.116 Overall, data from a systematic review and a prospective study underscore that rates of misdiagnosis in FND since 1970 (once confirmed) are low, and between 1% and 4%.117118

Recently, efforts have been made to integrate additional clinical features in the process of diagnosis, such as, for example, abrupt onset, fluctuations of the motor symptom, comorbid pain, and fatigue.119 The presence of these features should raise the index of suspicion and prompt a more systematic search of signs positive for FND.

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Diagnosis and management of functional neurological disorder - The BMJ

STOCKHOLM, April 27, 2022 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that an article about long-term health outcomes of the investigational anti-amyloid-beta (A) protofibril antibody lecanemab (BAN2401) in people living with early Alzheimer's disease (AD), using disease modeling, was published in the peer-reviewed journal Neurology and Therapy. In this simulation, lecanemab treatment is estimated to slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of the disease.

The article focuses on the long-term clinical outcomes for people living with early AD (mild cognitive impairment (MCI) and mild AD) who have amyloid pathology, comparing lecanemab together with standard of care (SoC) versus SoC alone (acetylcholinesterase inhibitor or memantine). The simulation is based on patients being treated until they reach the moderate AD stage. The disease simulation model (AD ACE model1) is based on the results of the Phase 2b clinical trial evaluating the efficacy and safety of lecanemab, and from ADNI (Alzheimer's Disease Neuroimaging Initiative) study results.

Lecanemab treatment was estimated to slow the rate of disease progression, resulting in an extended duration of MCI due to AD and mild AD dementia and shortened the duration in moderate and severe AD dementia. In the model the mean time advancing to mild, moderate, and severe AD dementia was longer for patients in the lecanemab-treated group than for patients in the SoC group by 2.51 years, 3.13 and 2.34, respectively. The model also predicted a lower life-time probability of admission to institutional care with lecanemab treatment.

"The results from the simulation done by Eisai demonstrate the potential clinical value of lecanemab for patients with early AD and how it could slow the rate of disease progression, delay progression to AD dementia with several years and reduce the need for institutionalized care. Analyses such as these are important to understand the potential long-term effects for patient, families and society offered by lecanemab treatment beyond what can be seen in clinical trials. The outcome of the Clarity AD Phase 3 study will be essential to further refining this model, and we are looking forward to the topline results later this year," said Gunilla Osswald, BioArctic's CEO.

Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway in the second quarter 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial is expected by end of September 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

For further information, please contact:Gunilla Osswald, CEO E-mail: [emailprotected] Phone: +46 8 695 69 30

Oskar Bosson, VP Communications and IRE-mail: [emailprotected]Phone: +46 70 410 71 80

The information was released for public disclosure, through the agency of the contact persons above, on April 27, 2022, at 08:00 a.m. CET.

About lecanemab (BAN2401)Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to, neutralize and eliminate soluble toxic A aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Eisai obtained the global rights to study, develop, manufacture, and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Currently, lecanemab is being studied in a pivotal Phase 3 clinical study in symptomatic early AD (Clarity AD), following the outcome of the Phase 2b clinical study (Study 201). In addition, the Phase 3 clinical study, AHEAD 3-45, for individuals with preclinical (asymptomatic) AD, meaning they are clinically normal and have intermediate or elevated levels of brain amyloid, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium, funded by the National Institute on Aging, part of the National Institutes of Health, and Eisai. In 2021, DIAN-TU selected lecanemab for a clinical trial for dominantly inherited Alzheimer's disease as a background anti-amyloid treatment when exploring combination therapies with anti tau treatments in dominantly inherited Alzheimer's disease subjects. In June 2021, FDA granted lecanemab Breakthrough Therapy designation and in September 2021, Eisai initiated a rolling submission for the US FDA Biologics license application of lecanemab for early Alzheimer's disease under the accelerated approval pathway. In December 2021, FDA granted lecanemab Fast track designation and the second part of the rolling application was submitted. Eisai expects the rolling submission to be completed during the second quarter 2022.

About the collaboration between BioArctic and EisaiSince 2005, BioArctic has long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed in December 2007, and the Development and Commercialization agreement for the antibody BAN2401 back-up for Alzheimer's disease, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory filings, approvals, and sales milestones as well as royalties on global sales.

About BioArctic ABBioArctic AB (publ) is a Swedish research-based biopharma company focusing on disease-modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease. BioArctic focuses on innovative treatments in areas with high unmet medical needs. The company was founded in 2003 based on innovative research from Uppsala University, Sweden. Collaborations with universities are of great importance to the company together with its strategically important global partner Eisai in Alzheimer disease. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market and out-licensing potential. BioArctic's Class B share is listed on Nasdaq Stockholm Mid Cap (ticker: BIOA B). For more information about BioArctic, please visit http://www.bioarctic.com.

1Kansal AR, Tafazzoli A, Ishak KJ, Krotneva S. Alzheimer's disease Archimedes condition-event simulator: Development and validation. Alzheimers Dement (NY). 2018;4:76-88. Published 2018 Feb 16. doi:10.1016/j.trci.2018.01.001Tafazzoli and Kansal. Disease simulation in drug development, External validation confirms benefit in decision making. The Evidence Forum. 2018.https://www.evidera.com/wp-content/uploads/2018/10/07-Disease-Simulation-in-Drug-Development_Fall2018.pdf

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Modeling published in Neurology and Therapy suggests that lecanemab could delay progression to Alzheimer's dementia by several years - PR Newswire

EXTON, Pa., Jan. 27, 2022 /PRNewswire/ -- On January 11th, the Centers for Medicare and Medicaid Services (CMS)' proposed Medicare reimbursement of FDA-approved anti-amyloid monoclonal antibodies (mAbs) be limited to clinical trials under Coverage with Evidence Development (CED). Days later, Spherix surveyed 75 U.S. neurologists and Alzheimer's disease specialists (including five follow-up interviews) to evaluate their awareness of and opinions on this unprecedented event.

The resulting insights are part of a two-wave Special Topix: Impact of CMS Reimbursement Decision on Alzheimer's Disease Therapies service. The second wave will be fielded immediately following the publication of the final determination.

Key takeaways from the first wave of research include:

Indeed, according to an interviewed neurologist, "To pre-judge before the data is submitted on the other three products is unfair. I don't think that that's reasonable because one of them may show a significant clinical improvement."

One neurologist noted, "If Lilly had very strong data on clinical benefit [with donanemab], not just clearing of amyloid, and on the side effect profile, I hope that CMS would change its decision for that particular drug."

Positive cognitive and functional data with acceptable safety from at least one of the ongoing Phase III programs with anti-amyloid mAbs would positively impact neurologists' currently low willingness to participate in such trials.

As mentioned by one interviewed neurologist, "The FDA is very concerning. As you probably are aware, the advisory committee, which were all neurologists and memory disorder neurologists, almost unanimously recommended against it [Aduhelm's approval] and then the FDA went around and said yes, so you lose a lot of confidence right now. My confidence in CMS is much better, much improved. I think they did the right thing. I think this is necessary. Too expensive and too potentially harmful to just willy-nilly start using these medications. We need to know definitively that these are really beneficial."

While CMS' draft NCD decision is specific to anti-amyloid mAbs, the Special Topix report also captures insights on the potential impact that the proposal could have on emerging therapies for Alzheimer's disease with alternative mechanisms of action (i.e., non-amyloid-targeted).

About Special Topix

Special Topix: Impact of CMS Reimbursement Decision on Alzheimer's Disease Therapies (US)includes two waves of research, collecting feedback from U.S. neurologists and Alzheimer's disease specialists about their awareness of and opinions on CMS' draft and final National Coverage Determination (NCD) decision on FDA-approved mAbs targeting amyloid for the treatment of Alzheimer's disease. The waves of research will field immediately following the releases of the draft and final NCD decisions.

Therapies covered include:

Learn more about our services here.

About Spherix Global Insights

Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information, contact:

Virginia Schobel, Neurology Franchise Head

info@spherixglobalinsights.com

http://www.spherixglobalinsights.com

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TOKYO, April 26, 2022 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") today announced an article about long-term health outcomes of its investigational anti-amyloid-beta (A) protofibril antibody lecanemab in people living with early Alzheimer's disease (AD) using simulation modeling was published in a peer-reviewed journal Neurology and Therapy. In this simulation, lecanemab treatment is estimated to potentially slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of mild cognitive impairment (MCI) due to AD and mild AD (collectively, early AD).

Eisai logo. (PRNewsFoto/Eisai Inc.)

The article describes the comparison of the long-term clinical outcomes for the people living with early AD who have amyloid pathology with standard of care (SoC) alone (including stable use of acetylcholinesterase inhibitor or memantine), and with lecanemab with SoC (lecanemab+SoC), using the disease simulation model (AD ACE model1,2) based on the results of a Phase IIb clinical trial (Study 201) evaluating the efficacy and safety of lecanemab. SoC data were estimated from ADNI (Alzheimer's Disease Neuroimaging Initiative) study results. It was shown that the estimated lifetime risk of disease progression to mild, moderate, and severe AD dementia from baseline could potentially be reduced by 7%, 13% and 10% in lecanemab+SoC, respectively, compared to SoC. In the model the mean time advancing to mild, moderate, and severe AD dementia was longer for patients in the lecanemab-treated group than for patients in the SoC group by 2.51 years (SoC vs. lecanemab+Soc: 3.10 vs.5.61 years), 3.13 (6.14 vs. 9.27 years) and 2.34 (9.07 vs.11.41 years) respectively. Subgroup analysis by age and disease severity at baseline also revealed a potentially greater impact on disease progression with earlier initiation of treatment with lecanemab. The incremental mean times for transition to mild and moderate AD dementia were 2.53 and 3.34 years, respectively, when treating MCI due to AD in a subgroup analysis compared to SoC.

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"With an increasing and aging global population, the number of people diagnosed with Alzheimer's disease will only continue to increase, making it an even more important and urgent public health priority. Alzheimer's disease is growing issue in regard to medical and nursing care costs, but also costs of informal care by family, leading to increased anxiety. The findings from the simulation model suggest early treatment with lecanemab may delay progression to the more severe stages of AD, potentially giving people living with early AD and their loved ones more time together and possibly reducing healthcare costs," said Ivan Cheung, Chairman, Eisai Inc., Senior Vice President, President Neurology Business Group and Global Alzheimer's Disease Officer, Eisai Co., Ltd. "These predicted and simulated long-term health outcomes provide insights for healthcare decision-makers regarding the potential clinical and socioeconomic value of lecanemab. Ongoing Phase 3 studies will soon be able to inform the model inputs and refine the findings. As part of Eisai's commitment to our human healthcare mission and transparency, we will continue to publish data and information about lecanemab."

Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway in the first quarter of Eisai's fiscal year 2022, which began April 1, 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.

1 Kansal AR, Tafazzoli A, Ishak KJ, Krotneva S. Alzheimer's disease Archimedes condition-event simulator: Development and validation. Alzheimers Dement (NY). 2018;4:76-88. Published 2018 Feb 16. doi:10.1016/j.trci.2018.01.0012 Tafazzoli and Kansal. Disease simulation in drug development, External validation confirms benefit in decision making. The Evidence Forum. 2018.https://www.evidera.com/wp-content/uploads/2018/10/07-Disease-Simulation-in-Drug-Development_Fall2018.pdf

Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120

[Notes to editors]

1. About Lecanemab (BAN2401)Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (A) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Currently, lecanemab is being developed as the only anti- A antibody that can be used for the treatment of early AD without the need for titration. With regard to the results from pre-specified analysis at 18 months of treatment, Study 201 demonstrated reduction of brain A accumulation (P<0.0001) and slowing of disease progression measured by ADCOMS* (P<0.05) in early AD patients. The study did not achieve super superiority its primary outcome measure** at 12 months of treatment. The Study 201 open-label extension was initiated after completion of the Core period and a Gap period off treatment of 9-59 months (average of 24 months, n=180 from core study enrolled) to evaluate safety and efficacy, and is underway.

Currently, lecanemab is being studied in a confirmatory Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase 2 clinical study (Study 201). Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007.

* ADCOMS (AD Composite Score), developed by Eisai, combines items from the ADAS-Cog (AD Assessment Scale-cognitive subscale), Clinical Dementia Rating (CDR) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment.** An 80% or higher estimated probability of demonstrating 25% or greater slowing super superiority in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placebo.

2. About the Collaboration between Eisai and Biogen for Alzheimer's DiseaseEisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product.

3. About the Collaboration between Eisai and BioArctic for Alzheimer's DiseaseSince 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the lecanemab antibody was signed in December 2007, and the development and commercialization agreement on the antibody lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for lecanemab in AD.

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LONG-TERM HEALTH OUTCOMES USING SIMULATION MODEL OF INVESTIGATIONAL LECANEMAB IN PATIENTS WITH EARLY ALZHEIMER'S DISEASE PUBLISHED IN A PEER-REVIEWED...

DUBLIN, Ireland, April 25, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the presentation of interim data from the ongoing RESTORE open-label extension/switch study of FT218 at the 2022 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 24-26, 2022. FT218 is the Companys lead drug candidate, an investigational formulation of sodium oxybate designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. The presentation highlights results from a questionnaire assessing patient preference for the once-nightly versus twice-nightly dosing regimen and another questionnaire assessing experiences with the second nightly dose in patients who switched from twice-nightly oxybates to FT218.

Twice-nightly oxybates for narcolepsy require a challenging dosing regimen that disrupts nighttime sleep. The results from the nocturnal adverse event questionnaire illustrate the burden that the second dose places on some patients, who already struggle with getting a full night of refreshing sleep, said Asim Roy, M.D., presenting author and Medical Director of the Ohio Sleep Medicine Institute. In my experience with patients in my practice, a once-at-bedtime option like FT218 would ease this burden and has the potential to be a major advance for the entire narcolepsy community.

At an interim data cutoff date of September 7, 2021, 35 participants who switched from twice-nightly oxybates to once-at-bedtime FT218 completed patient preference questionnaires three months after switching, with responses indicating that 94.3% (33/35 participants) preferred the once-nightly versus twice-nightly dosing regimen. As of the data cutoff, 60 participants who switched from twice-nightly oxybates to FT218 also completed a nocturnal adverse event questionnaire prior to switching to assess their experiences with the second nightly sodium oxybate dose. Results from the questionnaire follow:

These interim results from the ongoing RESTORE study highlight the preference for the once-at-bedtime versus twice-nightly dosing regimen among people who have switched from the twice-nightly formulation, said Douglas Williamson, M.D., Chief Medical Officer of Avadel. Further, they provide an insight into the challenges that patients face with a second, middle-of-the-night dose; challenges which may have been underappreciated due to the lack of other oxybate options. By eliminating the need for a second dose, FT218 has the potential to ease the burden facing sodium oxybate-eligible narcolepsy patients, if approved.

The abstract is available on the AAN website, and the virtual poster hall will be available to registrants until May 14, 2022.

About NarcolepsyNarcolepsy is a chronic neurological condition that impairs the brain's ability to regulate the sleep-wake cycle. The condition affects approximately one in 2,000 people in the United States with the cardinal symptom of EDS. Additional symptoms can vary by person and may include DNS, a sudden loss of muscle tone usually triggered by strong emotion (cataplexy), sleep paralysis and hypnagogic and hypnopompic hallucinations.

About FT218FT218 is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of EDS or cataplexy in adults with narcolepsy.

In March 2020, Avadel completed the REST-ON trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of FT218 in adults with narcolepsy. Among the three co-primary endpoints, FT218 demonstrated statistically significant and clinically meaningful results in EDS, the clinicians overall assessment of the patients functioning, and reduction in cataplexy attacks for all three evaluated doses compared to placebo.

In January 2018, the FDA granted FT218 Orphan Drug Designation for the treatment of narcolepsy based on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for those with narcolepsy due to the consequences of middle-of-the-night dosing of the approved product. A marketing application for FT218 is currently under review by the FDA.

Avadel is currently evaluating the long-term safety and tolerability of FT218 in the open-label RESTORE clinical study. For more information, visit: http://www.restore-narcolepsy-study.com.

AboutAvadel Pharmaceuticals plcAvadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Our current lead drug candidate, FT218, is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of EDS and cataplexy in adults with narcolepsy. For more information, please visit http://www.avadel.com.

Cautionary Disclosure Regarding Forward-Looking StatementsThis press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, our expectations of the therapeutic benefits and tolerability of FT218, if approved; and patient preference and market acceptance of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as will, may, could, believe, expect, look forward, on track, guidance, anticipate, estimate, project, next steps and similar expressions, and the negatives thereof (if applicable).

Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the Risk Factors section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2021, which we filed with the Securities and Exchange Commission on March 16, 2022, and subsequent SEC filings.

Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

Investor Contact:Courtney TurianoStern Investor Relations, Inc. Courtney.Turiano@sternir.com (212) 698-8687

Media Contact:Nicole Raisch GoelzReal Chemistryngoelz@realchemistry.com(408) 568-4292

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Avadel Pharmaceuticals Announces Interim Data from the Open-Label RESTORE Study at the 2022 American Academy of Neurology Annual Meeting -...

Quirnsalud has a headache programme in all its centers in the province of Alicante in which this condition is addressed comprehensively.

Three out of ten consultations in primary care and neurology are prompted by headaches and migraines, according to the Spanish Society of Neurology. The high incidence, says Dr. Erika Torres, neurologist and specialist in headaches at Quirnsalud Torrevieja and Alicante, delays access to a specialized consultation and increases the risk of chronic pain and disability by not obtaining a diagnosis, treatment and adequate follow-up of the patient.

Poorly controlled headaches can become a major cause of functional limitation and disability, causing repercussions that reduce the quality of life in all areas of life for the patient: work, family, leisure, etc. For this reason, indicates the neurologist from Quirnsalud Torrevieja and Alicante, it is essential to carry out an adequate and early diagnosis of the type of headache suffered in order to carry out the correct treatment, personalizing it, taking into account the specific characteristics of each patient.

Differences between migraines and headaches

Headaches are divided into two groups: a first group that includes primary headaches, including sporadic or chronic migraines and tension headaches in which the pain is not related to any disease, and a second group that includes secondary headaches in which there is an underlying cause for the headache and is a symptom of another disease such as eye disorders or fever. Tension-type headache would be the most prevalent type of primary headache, affecting 66% of the population.

Migraines are expressed with different symptoms than tension headache. As Dr. Torres explains, While migraine presents as a pain on one side of the head with pulsating characteristics or very intense pressure that can be accompanied by nausea, vomiting and discomfort from sounds, light or smells, tension-type headache is located in the whole head, with less intense pain than migraine, but uncomfortable because it is more constant and is usually associated with a feeling of dizziness and dullness.

To avoid chronic headaches, Dr. Torres recommends healthy lifestyle habits, not abusing painkillers and going to a specialist to receive adequate treatment.

Quirnsalud Alicante and Torrevieja, benchmarks in the treatment of headaches

Quirnsalud has a headache programme in all centeres in the province of Alicante in which headaches are addressed comprehensively. Patients have quick access to a consultant who, from the beginning, guides the patient about their type of headache, carrying out the necessary studies in each case. The program also includes the neurological nursing consultation service in which the patient is educated on pathology, their life habits are analyzed in detail and recommendations are made on what hygienic-dietary measures can help improve their quality of life.

This program also provides the patient with the most advanced treatments such as the administration of Botox for migraine and chronic tension-type headache, the new monoclonals with subcutaneous application for sporadic migraine and the rest of the therapeutic arsenal for less frequent headaches but just as important to alleviate suffering of the patient caused by conditions such as trigeminal neuralgia, occipital neuralgia, cluster headache, etc.

The patient has close contact with the professionals throughout and the health professionals will resolve all doubts quickly and continuously, both in person, by telephone and via email.

More information about headaches can be found in the video

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Three out of ten consultations in primary care and neurology are referred for headaches - Euro Weekly News