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Articles

After results indicated significant slowing of ALS disease progression, Coya noted it plans to file an IND with the FDA in the second half of 2023 for a potential clinical study thereafter.

Treg Suppressing Agent COYA 302 Shows Slowing of ALS Disease Progression

If approved, ABBV-951 will become the first subcutaneous delivery of carbidopa/levodopa, often considered the standard of care for symptom management for patients with Parkinson disease.

FDA Issues Complete Response Letter for AbbVie’s 24-Hour Continuous Carbidopa/Levodopa Pump

The professor of neurology and pediatrics at University of Rochester Medical Center shared her thoughts on the 2023 MDA Clinical and Scientific Conference, and the progress made in the treatment of neuromuscular disorders. 

NeuroVoices: Emma Ciafaloni, MD, on Mounting Progress in the Neuromuscular Field, Duchenne Muscular Dystrophy

Videos

The palliative care physician and assistant professor of medicine at Johns Hopkins Bayview Medical Center provided perspective on current state of end-of-life care for neuromuscular disorders and areas to improve upon. [WATCH TIME: 4 minutes]

Raised Awareness and Need For Improvements to End of Life Care in Neuromuscular Disorders: Ambereen Mehta, MD, MPH

The neurologist and migraine expert from NYU Langone Health.

The neurologist and migraine expert from NYU Langone Health shared her reactions to the recently approved zavegepant nasal spray (Zavzpret; Pfizer) for the treatment of migraine. [WATCH TIME: 5 minutes]  

Newly Approved Migraine Nasal Spray Offers Alternative Treatment to Injections, Oral Medications: Shae Datta, MD

Slideshows

Here's the latest multidisciplinary MS research published online first in the International Journal of MS Care.

IJMSC Online First: March 2023

Director, Comprehensive Epilepsy Center, NYU Langone Health

The director of the Comprehensive Epilepsy Center at NYU Langone discussed the importance of healthy eating habits and whether all individuals with epilepsy should consider dieting early in their life. [WATCH TIME: 4 minutes]

Importance of Establishing Healthy Eating Habits in Epilepsy: Orrin Devinsky, MD

The vascular neurologist at Cleveland Clinic provided an overview of a study that assessed the extent HbA1c impacts the relationship between mechanical thrombectomy and poor outcomes. [WATCH TIME: 3 minutes]

Effect of HbA1c Elevation, Glycemic Control Following Mechanical Thrombectomy: David Baker, DO

Dementia & Alzheimer's disease condition center is a resource for news on the diagnosis, treatment, & management of dementia & Alzheimer's. | NeurologyLive.


Dementia & Alzheimer Disease | Clinical Neurology News | NeurologyLive

NeurologyLive is your direct connection to the latest neurology news and interviews with expert neurologists in multimedia formats.

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Clinical

 dementia and Alzheimer disease clinical focus page provides information, podcasts, videos, and news about the latest FDA actions, clinical guideline updates, study and clinical trial findings, and interviews with physicians related to the care of patients with dementia and similar diseases, including Lewy body dementia, frontotemporal dementia, Alzheimer disease, and more.

's featured content in the carousel below.

 to subscribe on your favorite streaming service.

 podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis (MS), Parkinson disease, dementia, sleep disorders, and more.

This episode, "Lecanemab Approved for Alzheimer Disease," features an exclusive interview with Sharon Cohen, MD, FRCPC, a behavioral neurologist and medical director of the Toronto Memory Program at the University of Toronto, and a trial investigator for Clarity AD, the phase 3 trial of lecanemab. Similar to its predecessor, lecanemab was approved via the accelerated approval pathway, with the application supported by data from the phase 2b proof-of-concept clinical trial, known as Study 201 (NCT01767311). The pivotal phase 3 Clarity AD trial (NCT03887455), which is anticipated to serve as supplementary data and is pending review by the FDA.

 – Lecanemab (Leqembi; Eisai) approved for Alzheimer disease

 – Sharon Cohen, MD, FRCPC, on the approval

 – Supporting context on the accelerated approval pathway for lecanemab

 – Questions about access amid current CMS guidance

 – Data from the supporting phase 2 study, Study 201

 – Safety and the 3 patient deaths reported in the clinical trial program

 podcast. Be sure to leave a rating and review for the show. Thanks for listening!

REFERENCES
1. FDA grants accelerated approval for Alzheimer's disease treatment. FDA. News release. January 6, 2023. Accessed January 9, 2023. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment

Looking for more Alzheimer disease discussion? 
Check out this 

Marwan Sabbagh, MD; 
Alireza Atri, MD, PhD; Sharon Cohen, MD, FRCPC; and Eric McDade, DO.

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Sharon Cohen, MD, FRCPC. [LISTEN TIME: 14 minutes]

Special Episode: Lecanemab Approved for Alzheimer Disease

 podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis, Parkinson disease, dementia, sleep disorders, and more.

Episode 79, "A New Monoclonal for Alzheimer Disease," features an exclusive interview with Marwan Sabbagh, MD, FAAN, behavioral neurologist at the Barrow Neurological Institute. He joined the show to discuss the clinical trial results for lecanemab that were presented at the Clinical Trials on Alzheimer’s Disease meeting in San Francisco, the drug’s overall efficacy profile, as well safety information and the rates of ARIA, and more.

Lecanemab (Biogen/Eisai), is a humanized monoclonal antibody that eliminates toxic amyloid-ß protofibrils that is set to follow aducanumab as the next approved treatment for patients with early Alzheimer disease. The FDA is set to decide on the treatment's approval by January 6, 2023.

 (NCT01767311), one of the supporting trials for its new drug application, lecanemab showed a statistically significant 27% reduction in the primary end point of Clinical Dementia Rating-Sum of Boxes when compared with placebo over an 18-month treatment period (

 = .00005). Investigators reported an ARIA-edema rate of 12.5% for those on lecanemab compared with 1.7% for those on placebo. Symptomatic ARIA-E occurred at a rate of 2.8% in the lecanemab group and 0.0% in the placebo group.

This episode is brought to you by the Giants of Multiple Sclerosis®. This premier neuroscience award program celebrates pioneers, innovators, and future generations of leaders for their remarkable achievements in Multiple Sclerosis. Nominations close January 31, 2023!

The stories featured in this week's Neurology News Minute, which will give you quick updates on the following developments in neurology, are further detailed here:

Roche Gets FDA Clearance for CSF Beta-Amyloid and Phospho-Tau Alzheimer Disease Assays

BrainStorm Submits Type A Meeting Request Regarding NurOwn ALS Treatment

Seizure-Free Days and Duration Intervals Increased with Fenfluramine in Dravet Syndrome

Episode Breakdown

Hoping to listen on your favorite podcast app? See below:

REFERENCE
1. Irizarry M, van Dyck C, Sabbagh M, Bateman R, Cohen S. Clarity AD: A phase 3 placebo-controlled, double-blind, parallel-group, 18-month study evaluating lecanemab in early Alzheimer disease. Presented at: CTAD Conference, November 29-Dec 2.

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Marwan Sabbagh, MD, FAAN. [LISTEN TIME: 21 minutes]

Episode 79: A New Monoclonal for Alzheimer Disease

Episode 75, "Focusing on the Future of Neurology," features a trio of exclusive interviews with the chairs of the recently hosted International Congress on the Future of Neurology (IFN), including Stephen Krieger, MD, professor of neurology and neurologist at the Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai; Richard Isaacson, MD, director of the Center for Brain Health at the Florida Atlantic University Schmidt College of Medicine; and Jessica Ailani, MD, associate professor of neurology and director of the MedStar Georgetown Headache Center. They joined the show to recap their experience at the 2022 IFN meeting, discuss the value of cross-specialty interactions, share their perspective on the future of their fields, and more.

. Check out new episodes of a variety of shows, airing every single day, only on

The 4th Annual International Congress on the Future of Neurology

 showcased the most recent advancements in neurologic disorders, featuring practice-changing discussions and presentations of strategies for incorporating new therapies into practice, as well as a comprehensive overview of pharmacological and nonpharmacological modalities.

Occurring over 2 days, the educational program delivered information through a mix of clinical data presentations, case-based discussions, and robust Q&A sessions. Each year, this symposium brings together world-renowned experts in their respective fields to discuss the impact of new evidence and novel agents in the treatment of neurologic disorders in a highly practical and engaging format.

To learn more about the IFN Congress and other Physician's Education Resource CME activities, visit

Mind Moments®, a podcast from NeurologyLive®, brings you exclusive interviews with Stephen Krieger, MD; Richard Isaacson, MD; and Jessica Ailani, MD. [LISTEN TIME: 24 minutes]

Episode 75: Focusing on the Future of Neurology

Episode 73, "Updates in Epilepsy Treatment," features an exclusive interview with Ambereen Mehta, MD, MPH, palliative care physician and assistant professor of medicine, Johns Hopkins Bayview Medical Center. She joined the show to discuss palliative care and its evolving role in the care paradigm for patients with chronic neurologic disease, as well as its history in the United States, how it differs from hospice care, and more.

To learn more about neuropalliative care, head to our 

International Neuropalliative Care Society (INPCS) partner page

FDA Accepts Application for Trofinetide in Rett Syndrome

LIFT-AD Study Amended to Assess Alzheimer Disease Agent Fosgonimeton as Monotherapy

Tolerizing MS Vaccine Displays Efficacy in Model of Relapsing-Remitting Multiple Sclerosis

REFERENCES
1. Shemme AJ, Phillips JN, Bloise R, Koehler TJ, Gorelick PB, Francis BA. The Impact of a Neurocritical Care and Neuropalliative Collaboration on Intensive Care Unit Outcomes. 

. 2022;39(6):687-694. doi:10.1177/10499091211060055
2. Mehta AK, Wright SM, Wu DS, Harris CM. Palliative Care Involvement in Patients Hospitalized in the United States with Aneurysmal Subarachnoid Hemorrhage. 

. 2021;24(10):1555-1560. doi:10.1089/jpm.2021.0116
3. Williamson TL, Adil SM, Shalita C, et al. Palliative Care Consultations in Patients with Severe Traumatic Brain Injury: Who Receives Palliative Care Consultations and What Does that Mean for Utilization? 

. 2022;36(3):781-790. doi:10.1007/s12028-021-01366-2
4. Bužgová R, Kozáková R, Bar M. The effect of neuropalliative care on quality of life and satisfaction with quality of care in patients with progressive neurological disease and their family caregivers: an interventional control study. 

. 2020;19(1):143. doi:10.1186/s12904-020-00651-9
5. Mehta AK, Jackson NJ, Wiedau-Pazos M. Palliative Care Consults in an Inpatient Setting for Patients With Amyotrophic Lateral Sclerosis. 

. 2021;38(9):1091-1098. doi:10.1177/1049909120969959
6. Lou W, Granstein JH, Wabl R, Singh A, Wahlster S, Creutzfeldt CJ. Taking a Chance to Recover: Families Look Back on the Decision to Pursue Tracheostomy After Severe Acute Brain Injury. 

. 2022;36(2):504-510. doi:10.1007/s12028-021-01335-9.
7. Miyasaki JM, Kluger BM (ed). 

. Neuropalliative Care - Part I. 2022;190:2-243
8. Lou W, Granstein JH, Wabl R, Singh A, Wahlster S, Creutzfeldt CJ. Taking a Chance to Recover: Families Look Back on the Decision to Pursue Tracheostomy After Severe Acute Brain Injury. 

. 2022;36(2):504-510. doi:10.1007/s12028-021-01335-9
9. Phillips JN, Besbris J, Foster LA, Kramer NM, Maiser S, Mehta AK. Models of outpatient neuropalliative care for patients with amyotrophic lateral sclerosis. 

. 2020;95(17):782-788. doi:10.1212/WNL.0000000000010831

International Neuropalliative Care Society (INPCS)

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Ambereen Mehta, MD, MPH. [LISTEN TIME: 40 minutes]

Episode 73: The Role of Palliative Care in Neurology

The pathway through the clinical development pipeline for any therapy is often clear. Drugs are tested preclinically and pharmacokinetically; then into the phases of human testing; and then, once approved, postmarketing data is collected. In Alzheimer disease, few therapies have made it to that point. Many are halted without showing a therapeutic effect. The difficulty in modifying this disease has resulted in the journey of many drugs being complex, sometimes taking two steps forward only to take three steps back. The challenge Alzheimer has posed for the research and development and clinical communities has been a near Sisyphean task, with the growth in knowledge about the disease not yet matched by therapeutic success.

One year ago, on June 7, 2021, the FDA granted special approval to the disease’s first treatment in almost two decades. The therapy acted on a known target for the disease, and it had been assessed in a large, global population of individuals. But the joy of that milestone did not last. In Icarian fashion, aducanumab’s path through the pipeline catapulted it forward with accelerated approval, only to see it fall backward, hampered by controversy and debate.

. Check out new episodes every Tuesday and Thursday only on

in which the cover story features an in-depth review of the aducanumab saga from David S. Knopman, MD, some of which is featured in this episode.

After being discovered at the University of Zurich, the monoclonal antibody was developed by Biogen, with a 2016 phase 1 study showing that the drug dramatically reduced amyloid-β peptide levels in the brain, and appeared to possibly slow cognitive decline in a dose-dependent manner. With those promising phase 1 clinical trial results, Biogen then launched 2 large and identically designed, pivotal phase 3 studies—EMERGE and ENGAGE—in 2015.

concerns were raised about Aß-related imaging abnormalities

, known as ARIA, especially in those individuals who were 

 ɛ4 allele carriers. This led to a restriction on the highest dose in the ɛ4 genotype group, followed by a dose escalation was introduced midway through the trials in March 2017. A preplanned interim analysis for futility of data up to December 2018 was carried out, but this failed to take into account the dose escalation. Biogen 

 in March 2019 as a result of the analysis, which showed no benefit in ENGAGE and a trend toward minimal clinical benefit in EMERGE.

 was then conducted after 3 additional months of data became available, showing a statistically significant benefit on the primary outcome measure—the Clinical Dementia Rating Scale sum of boxes—in EMERGE’s high-dose group. But the high-dose group in ENGAGE still lacked evidence of benefit.

With these data and the FDA’s permission to 

, Biogen presented the revised analysis, along with several additional post hoc analyses, to those gathered at the 2019 Clinical Trials in Alzheimer Disease conference. The results were met with rigorous debate. And this debate continued for several months, culminating in an 

 in early November 2020. At this meeting Biogen, with support from the FDA, proposed that the EMERGE trial results were evidence of efficacy, questioning the failure of the ENGAGE to mimic this. The FDA advisory committee then voted, with 10 against 0—with 1 abstention—voting that aducanumab did not show substantial evidence of effectiveness.

The clinical community was left to absorb the results of the committee meeting while awaiting the FDA’s final decision in the following June. Those 7 months were met with continued discussion and debate about the therapy’s potential efficacy, safety concerns, and a pair of conflicting clinical trials. Then, one year ago, the 

, now given the brand name Aduhelm, in an accelerated fashion, requiring a phase 4 postmarketing trial to confirm the efficacy that it showed in Biogen’s data.

The decision, again, was met with controversy. Some in the medical community 

 expressing their desire to not use the medication. Others expressed joy at the proposition of patients finally receiving an option after so many years without. This back and forth around the therapy continued for several months, until early April 2022, when, in a 

, CMS agreed to provide Medicare coverage for aducanumab or any other agent in the class that was approved on the basis of accelerated approval, but with a caveat. It would cover the drugs only in the setting of a randomized, controlled trial. Furthermore, CMS restricted coverage to persons with mild cognitive impairment and mild dementia due to Alzheimer.

Then, just one month later, Biogen announced that it was “substantially eliminating commercial infrastructure related to Aduhelm.” It 

Aducanumab’s saga is not a sign that the research into Alzheimer or the development of treatments for it are set to slow down. But it does shine a light on something that the field has perhaps been heading toward all of these years. Regardless of its efficacy, it appears that amyloid-ß is just one piece of the puzzle. Alzheimer is a complex, multifaceted disease. It appears that successful treatment for it may need to be the same. I will leave you all today with a snippet of the cover story from the June 2022 issue of 

, in which Dr. David S. Knopman offers a far more in-depth chronicle of aducanumab’s story. From Dr. Knopman:

“The decision by Biogen to suspend commercialization of aducanumab would appear to seal the agent’s fate. If none of the other anti-Aß monoclonal antibodies show benefit, that will raise serious questions about the conceptual model on which therapy with anti-Aß monoclonal antibodies is based and seriously threaten the future of this class of treatments. On the other hand, if at least 1 of the other drugs shows a benefit on clinical grounds, the debate will shift to the magnitude of the clinical benefit in relation to risks.

A genuine clinical benefit, however modest, would be a powerful selling point for a successful anti-Aß monoclonal antibody. This writer hopes that these future discussions will be conducted in a thoughtful and collegial manner. A full appraisal of the evidence must be the starting point, but weighing the benefits vs the risks is a matter of judgment that should be dictated by the needs of our patients.

The sudden realization there may be a therapy that could be prescribed to a large number of patients with mild cognitive impairment and AD in the US revealed a striking lack of preparedness and highly unequal access in our health care system. There are not enough dementia care specialists with the expertise to make an accurate diagnosis and manage aducanumab therapy. There are also unmet needs for infrastructure that will limit access in underserved rural areas and in diverse urban communities, including prompt access to 3 T MRI scanners, infusion centers, and neurological intensive care units in the rare instances when ARIA becomes symptomatic in a serious way. Addressing these challenges will be a necessary step forward for the care of this patient population, regardless of what the future holds for the anti-Aß class of medicines.”

Click here to subscribe to the Mind Moments

Mind Moments®, a podcast from NeurologyLive®, brings you a special episode recap of aducanumab's journey from discovery to present, ahead of the June 2022 issue's in-depth cover story on the topic. [LISTEN TIME: 10 minutes]

Special Episode: Aducanumab and Anti-Amyloid-ß, One Year Later

Episode 61, "2022 AAN Annual Meeting Highlights," features interviews with a number of individuals who presented data and spoke at the American Academy of Neurology Annual Meeting, on topics ranging from COVID-19's clinical presentation, overall trends in the care of patients with multiple sclerosis, the potential of regenerative medicine in traumatic brain injury, the real-world and long-term use of new therapy for Lennox-Gastaut syndrome, the optimal timing for the newest therapy in neuromyelitis optica spectrum disorder, the Axon Registry and incorporating EHR information into its data collection, and the impact of the pandemic on clinician burnout and mental health. Those featured include Jennifer Frontera, MD; Stephen Krieger, MD; Peter McAllister, MD; Kelly Knupp, MD, MSCS; Bruce Cree, MD, PhD, MAS; Shrujal Baxi, MD, MPH; and Indu Subramanian, MD.

Note: As part of AAN policy for the Annual Meeting, all individuals were asked to remain masked throughout the week, so there may be some moments of muffled noises as participants adjust or shift their masks.

Click here for more coverage of AAN 2022.

American Academy of Neurology Annual Meeting

Mind Moments®, a podcast from NeurologyLive®, brings you exclusive interviews with Jennifer Frontera, MD; Stephen Krieger, MD; Peter McAllister, MD; Kelly Knupp, MD, MSCS; Bruce Cree, MD, PhD, MAS; Shrujal Baxi, MD, MPH; and Indu Subramanian, MD. [LISTEN TIME: 32 minutes]

Episode 61: 2022 AAN Annual Meeting Highlights

Episode 54, "The Shortage of Neurologists," features an exclusive interview with Jennifer Majersik, MD, MS, chief, division of vascular neurology, and professor of neurology, University of Utah, who along with 9 other colleagues, authored a report from the American Academy of Neurology (AAN) 2019 Transforming Leaders Program on the ongoing shortage of physicians in neurology. She offered her perspective on the challenge and how it can be addressed from an individual and institutional level.

REFERENCES
Majersik JJ, Ahmed A, Chen IA, et al. A shortage of neurologists – we must act now: A report from the AAN 2019 transforming leaders program. 

. Published online April 30, 2021. doi:10.1212/WNL.0000000000012111

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Jennifer Majersik, MD, MS.

Episode 54: The Shortage of Neurologists

The Mind Moments™ podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis (MS), Parkinson disease, dementia, sleep disorders, and more.

Episode 53, "A Landmark Year for Alzheimer Disease," features an exclusive interview with Anton Porsteinsson, MD, director, Alzheimer's Disease Care, Research and Education Program (AD-CARE); William B. and Sheila Konar Professor of Psychiatry, School of Medicine and Dentistry, University of Rochester. He shared his perspective on the progress made in Alzheimer disease in 2021, from the first approval since 2003 to the agents moving through the pipeline and the improved understanding of AD pathology, and offered a look into what the future may hold.

American Academy of Sleep Medicine Publishes Updated Recommendations on Referring OSA Candidates for Surgery

Phase 3 Study of BXCL501 for Agitation in Alzheimer Disease Initiated

FDA Accepts Ublituximab Biologics License Application for Relapsing MS

 to subscribe to the Mind Moments™ podcast. Be sure to leave a rating and review for the show. Thanks for listening!

Mind Moments™, a podcast from NeurologyLive®, brings you an exclusive interview with Anton Porsteinsson, MD.

Episode 53: A Landmark Year for Alzheimer Disease

The Mind Moments podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis, Parkinson disease, dementia, sleep disorders, and more.

Episode 43, "Is Telehealth Here to Stay for Alzheimer Disease Care?" features an exclusive interview with Jessica Zwerling, MD, MS, director, Montefiore Hudson Valley Center of Excellence for Alzheimer’s Disease, and associate professor of neurology, Albert Einstein College of Medicine. She shared her experience with telemedicine in this population over the last year and discussed how it and similar tools can increase access, help overcome social determinants of health, and encourage engagement with the community.

The stories feature in this week's Neurology News Minute, which will give you quick updates on the following developments in neurology, are further detailed here:

's coverage of the 2021 Alzheimer's Association International Conference

 to subscribe to the Mind Moments podcast. Be sure to leave a rating and review for the show. Thanks for listening!

Montefiore Health System

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive interview with Jessica Zwerling, MD, MS.

Episode 43: Is Telehealth Here to Stay for Alzheimer Disease Care?

Episode 39, "A Controversial FDA Decision," features insights from a number of individuals in the Alzheimer disease space, including neurologists, psychiatrists, and advocacy partners who share their varying and nuanced opinions on this decision to better understand not only what this approval means for clinical care, but what the downstream effects of it may be. Those individuals, in order of appearance, are: 

Marwan Sabbagh, MD, director, Cleveland Clinic Lou Ruvo Center for Brain Health, and investigator in the aducanumab trials

Anton P. Porsteinsson, MD, director, Alzheimer's Disease Care, Research and Education Program, University of Rochester School of Medicine and Dentistry, and investigator in the aducanumab trials

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive look into the FDA approval of aducanumab (Aduhelm; Biogen) for the treatment of Alzheimer disease.