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Articles

The rare disease population health strategy lead at UCB provided clinical insight on some of the unique challenges of diagnosing myasthenia gravis, and some of the early signs clinicians and non-specialists should look out for. [WATCH TIME: 3 minutes]

Identifying Small Clinical Characteristics to Facilitate Early Myasthenia Gravis Diagnosis: Judith Thompson, PhD

The multicenter, randomized, double-blind, placebo-controlled, parallel-group, event-driven trial will use time to clinical progression, defined as an increase in Clinical Dementia Rating score, as the primary end point.

Phase 3 TRAILRUNNER-ALZ 3 to Test Effects of IgG1 Monoclonal Antibody Remternetug in Early Alzheimer Disease

Videos

A trio of experts talked about Lexeo Therapeutics’ LX1001 gene therapy trial that demonstrated promising safety and biomarker effects in patients with early-stage Alzheimer disease. [WATCH TIME: 5 minutes]

Promising Innovative Gene Therapy for APOE4 Homozygous Alzheimer Disease: R. Nolan Townsend; Sandi See Tai, MD; Kim G. Johnson, MD

The chief medical officer at Cognito Therapeutics talked about a medical device designed to slow cognitive decline in patients with Alzheimer disease through gamma frequency brain stimulation. [WATCH TIME: 6 minutes]

Advancing Alzheimer Treatment Through Gamma Oscillation Stimulation: Ralph Kern, MD, MHSc

Professor, department of neurology, NYU Langone Health Center, and codirector, Epilepsy Clinical Trials, NYU Langone, Comprehensive Epilepsy Center; founder/director, Epilepsy Study Consortium.

The professor of neurology at NYU Grossman School of Medicine discussed the results of a phase 2b study on XEN1101, an investigational drug in development for focal epilepsy. [WATCH TIME: 4 minutes]

Overviewing Positive Phase 2 Data on Potassium Channel Inhibitor XEN1101: Jacqueline French, MD

Assistant professor of neurology at University of Colorado School of Medicine.

As part of our monthly clinician spotlight, NeurologyLive® highlighted movement disorder expert Sana Aslam, DO, an assistant professor of neurology at University of Colorado School of Medicine. 

NeurologyLive® Clinician of the Month Spotlight: Sana Aslam, DO

Vice President of Public Policy and Advocacy, Muscular Dystrophy Association (MDA)

Prior to the 2025 MDA Conference, the vice president of Public Policy & Advocacy at the Muscular Dystrophy Association talked about the increasing interest in gene therapy in the field of neuromuscular diseases.

The Significance of Gene Therapy in Neuromuscular Medicine at the 2025 MDA Conference: Paul Melmeyer, MPP

The professor of neurology at NYU Grossman School of Medicine provided clinical insight on the uniqueness of investigational XEN1101 and the idea behind potassium channel inhibitors to treat epilepsy. [WATCH TIME: 3 minutes]

Mechanism and Promise Behind XEN1101 in Focal Epilepsy: Jacqueline French, MD

The multiple sclerosis condition center is a resource for clinical news on the diagnosis, treatment, and management of multiple sclerosis. | NeurologyLive.


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Clinical

 MS Disease Spotlight page offers specific updates and coverage on the latest expert conversations and data readouts related to the treatment and management of patients with multiple sclerosis and demyelinating disorders.

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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.

In this episode, "Understanding Major Changes to New McDonald Criteria for Multiple Sclerosis," Daniel Ontaneda, MD, PhD, a staff member of the Cleveland Clinic Mellen Center for Multiple Sclerosis, provided an in-depth overview on the new McDonald criteria to diagnose multiple sclerosis (MS), which was presented at the 

40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

. Ontaneda, who also serves as an assistant professor of neurology, discussed the most notable changes to the criteria and how it may help towards improving rates of misdiagnosis and missed diagnosis. He spoke on the incorporation of new biomarkers, such as central vein sign and paramagnetic rim lesions, and the ability to diagnose MS in stages before clinical presentation shows. Furthermore, Ontaneda gave some perspective on the areas of the new criteria that will take some time to adjust to, as well as how these criteria may change the philosophical perspective of the disease as a whole.


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:

Potential Regulatory Submission for Inebilizumab in Myasthenia Gravis Following Positive Phase 3 MINT Data

Parkinson Agent Tavapadon Meets Primary and Secondary End Points as Monotherapy in Phase 3 TEMPO-1 Trial

Sage Therapeutics and Biogen Officially Announce Ending of SAGE-324 Program in Essential Tremor

 – Focus and direction of new diagnostic criteria

 – Overviewing specific changes to McDonald criteria

 – Approach to diagnosing pre-MS; treating radiologically isolated syndrome earlier

 – Incorporation of new biomarkers, central vein sign, paramagnetic rim lesions, OCT

 – Unanswered questions/challenges left out of the diagnostic criteria

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

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

European Committee for Treatment and Research in Multiple Sclerosis Congress (ECTRIMS)

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Daniel Ontaneda, MD, PhD. [LISTEN TIME: 27 minutes]

Episode 125: Understanding Major Changes to New McDonald Criteria for Multiple Sclerosis

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 47, "Incorporating Physical Therapy Into MS Care," features an exclusive interview with Patricia Bobryk, MHS, PT, MSCS, ATP, physical therapist, UC Health, and cochair, 

International Organization of MS Rehabilitation Therapists (IOMSRT)

. Bobryk shared her insight into the clinical care of MS from the perspective of a rehabilitative specialist, and the importance of including physical therapy approaches as part of the multidisciplinary approach to care as early as possible to ensure more beneficial long-term outcomes for patients, also speaking to the latest advances and developments in rehabilitative medicine.

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:

Noncontact Boxing Exercise Assessed for Parkinson Disease Benefit

Opicapone Demonstrates Small Benefit for Sleep in Parkinson Disease

Amylyx Announces Plans to Submit NDA for AMX0035 for ALS

Episode Breakdown

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive interview with Patricia Bobryk, MHS, PT, MSCS, ATP.

Episode 47: Incorporating Physical Therapy Into MS Care

Episode 38, "Advancing MS Care and Awareness," features an interview with Barry Hendin, MD, clinical professor, University of Arizona; director, Multiple Sclerosis Clinic, Banner University Medical Center; and chief medical officer, Multiple Sclerosis Association of America. He shared his perspective on the recent World MS Day on May 30, the impact awareness efforts have had on care, and how treatment has evolved during his time as a multiple scleorsis (MS) physician.

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive interview with Barry Hendin, MD.

Episode 38: Advancing MS Care and Awareness

A clinician’s guide to using a personalized medicine approach to monitor cognition in MS.

Holistic Personalized Care for Patients with Multiple Sclerosis and the Importance of Cognitive Monitoring

Multiple sclerosis affects nearly 3 million patients worldwide; new research is helping pave the way for developing new therapies and medications that get at the defining mechanisms that trigger immune regulation loss of this unpredictable central nervous system disease.

Study Findings Provide New Hope for Patients With Multiple Sclerosis

An IDMC review of unblinded interim data was positive and advised that the trials continue as planned, with time to first relapse up to 72 weeks as the primary end point.



Phase 3 ENSURE Program of Vidofludimus Calcium Continues Following Positive Futility Analysis

The 2024 revisions to the McDonald diagnostic criteria for multiple sclerosis (MS) mark a significant advancement in the early detection and diagnosis of the disease, with new biomarkers and a broadened scope that may lead to earlier intervention and improved patient outcomes.

Revised McDonald Diagnostic Criteria Signals New Era in Multiple Sclerosis Treatment

Sarah Anderson, PharmD, NBC-HWC, senior director of clinical resources and programming at National MS Society, talked about the significant updates under the Inflation Reduction Act to come in 2025 for patients with multiple sclerosis. 

Key Takeaways for MS Providers Regarding Major Medicare Changes Expected in 2025

A duo of experts talked about a phase 2 trial of vidofludimus calcium that revealed promising interim results with a reduction in serum neurofilament light levels, potentially slowing brain atrophy in patients with progressive multiple sclerosis

Promising Effects of Vidofludimus Calcium by Age and Disability in Progressive MS: Robert J. Fox, MD; Andreas Muehler, MD, MBA

"We need to get drugs that address both types of disability progression—relapse-associated worsening and progression independent of relapse activity. Vidofludimus calcium aims to meet that unmet medical need, especially for patients in later stages where progression becomes a significant concern."

European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress

, held September 18-20, in Copenhagen, Denmark, Immunic presented an interim analysis from the phase 2 CALLIPER study (NCT05054140) assessing its investigational agent vidofludimus calcium in patients with progressive multiple sclerosis (PMS). Overall, the interim analysis featured 203 patients from the study which evaluated the efficacy and safety of the agent, a nuclear receptor related 1 (Nurr1) activator.

After 24 weeks of treatment, patients in the trial showed a reduction in serum neurofilament light (NfL) by 22.4% (

= .01, post hoc), with effects that were consistent across each progressive MS subtype. In addition, among those with an Expanded Disability Status Scale (EDSS) score of less than 5.5, investigators observed a 10% decrease in NfL in vidofludimus calcium-treated patients vs a 20% increase for those on placebo. For those with EDSS scores above 5.5, there was a 2% decrease in the active treatment group vs a 12% increase for those on placebo.

During the meeting, Andreas Muehler, MD, MBA, chief medical officer at Immunic, sat down to discuss the mechanism of action behind vidofludimus calcium. In the discussion, he talked about the unique nature of the agent, and how it can impact relapse-associated worsening and progression independent of relapse activity. He stressed that the drug aims to cover both areas, which becomes especially crucial as patients progress in the later stages of the disease when relapse activity declines but disability progression continues.

REFERENCES
1. Fox RJ, Wolf C, Ondruš M, et al. Serum Neurofilament Changes in Progressive MS: Exploring the Impact of Vidofludimus Calcium by Age and Disability in the CALLIPER Study Interim Analysis. Presented at: 2024 ECTRIMS; September 18-20; Copenhagen, Denmark. Abstract 686.

The chief medical officer at Immunic provided clinical insight on the dual mechanism of action of vidofludimus calcium, and how its positioned as a treatment option across all MS subtypes. [WATCH TIME: 3 minutes]

How Vidofludimus Calcium Addresses Unmet Treatment Needs in Multiple Sclerosis: Andreas Muehler, MD, MBA

Sarah Anderson, PharmD, NBC-HWC, discussed the significant updates to Medicare Part D in 2025 that will cap annual out-of-pocket costs and introduce a flexible payment plan option for enrollees.

Medicare Part D 2025 Key Changes and Payment Plan for Multiple Sclerosis: Sarah Anderson, PharmD, NBC-HWC

"Beginning January 1, 2025, the Inflation Reduction Act caps annual out-of-pocket costs for Part D beneficiaries at $2,000, providing much-needed relief for many living with chronic conditions like MS."

The Inflation Reduction Act (IRA), signed into law in August 2022, aimed to address various healthcare concerns, specifically high prescription drug prices. At the time, the IRA granted Medicare the authority to negotiate prices for certain prescription drugs and set limits on out-of-pocket costs for Medicare Part D. Furthermore, it allowed Part D beneficiaries to spread their drug costs throughout the calendar year. These new provisions mark the most substantial changes to Medicare Part D since its launch in 2006, as noted by Nicole M. Boschi, PhD in a 

In the blog, Boschi, who serves as the director of regulatory affairs at the 

 (Society), noted that the Society has constantly worked to help increase treatment access patients living with multiple sclerosis (MS) rely on, including advocating for the passage of the IRA. Boschi also wrote in the blog post that the Society is dedicated to instructing healthcare providers on how to aid their patients, who have been impacted by MS, to navigate these changes to more affordable access medications that allow will allow them to experience a better quality of life.

If there are any clinicians that serve patients who are on Medicare Part D or Medicare Advantage plans, they may need to be informed about the big changes coming for their patients in 2025. To deep deeper, 

, senior director of clinical resources and programming at the Society, discussed how these changes will improve affordability for patients with high prescription drug costs. She also talked about the key features and benefits of the new Medicare Prescription Payment Plan. Moreover, Anderson spoke about how healthcare providers should guide their patients in enrolling and managing the new payment options.

https://www.nationalmssociety.org/resources/get-support/ms-navigator

The senior director of clinical resources and programming at National MS Society discussed the significant updates to Medicare Part D in 2025 that will cap annual out-of-pocket costs and introduce a flexible payment plan option for enrollees. [WATCH TIME: 9 minutes]

SAP Partners

Medicare Part D 2025 Key Changes and Payment Plan for Multiple Sclerosis: Sarah Anderson, PharmD, NBC-HWC 

 Xavier Montalban, MD, PhD, talked about the revision of the multiple sclerosis diagnostic criteria that will integrate new evidence, biological markers, and advanced MRI findings to enable earlier and more precise diagnoses.

Advancing Multiple Sclerosis Diagnosis With the 2024 Criteria Revision: Xavier Montalban, MD, PhD

"We are now moving towards a more biological diagnosis of multiple sclerosis, and this is essential. This is happening as well in other neurodegenerative diseases such as Parkinson and Alzheimer [disease]. We don't need symptoms to make the diagnosis of one specific disease, because once we have symptoms, we are a little bit late.”

2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress

, September 18-20, in Copenhagen, Denmark, several clinicians, including Xavier Montalban, MD, PhD, participated in a scientific session on the newly revised McDonald criteria. The session was cochaired by 

, codirector of the Precision Medicine MS Center at Johns Hopkins University, and Mar Tintoré, MD, PhD, senior consultant of the Multiple Sclerosis Centre of Catalonia at Hospital Universitari Vall d’Hebron in Barcelona.

Other speakers apart of the session included 

, a consultant neurologist at Queen's Square MS Center in London, United Kingdom, as well as 

, assistant professor at the University of Naples, and more. During the session, topics talked about by the speakers included practical implementation of the new criteria, moving towards a unified set of diagnostic criteria for MS, the impact of adding optical coherence tomography in the MS criteria, as well as validating proposed 2023 radiologically isolated syndrome criteria.

Following the meeting, Montalban, the chair of neurology at Hospital Universitari Vall d’Hebron, sat down with 

to discuss how the 2024 revisions of the MS diagnostic criteria will improve early diagnosis and patient outcomes. Montalban, who also serves as the chief of the Neuroimmunology Group at the Vall d’Hebron Research Institute, talked about the role of MRI advancements and biomarkers in the new MS diagnostic criteria. Moreover, he spoke about how the inclusion of the optic nerve as a fifth typical topography will potentially impact MS diagnosis in clinical practice.

Click here for more coverage of ECTRIMS 2024.

The chair of neurology at Hospital Universitari Vall d’Hebron talked about the revision of the MS diagnostic criteria that will integrate new evidence, biological markers, and advanced MRI findings to enable earlier and more precise diagnoses. [WATCH TIME: 4 minutes]

Marcello Moccia, MD, PhD, discussed how implementation of new diagnostic criteria for multiple sclerosis will involve practical adjustments in imaging and diagnostic techniques as well as cultural changes in clinical practice.

Cultural Shifts in Adapting to the New Criteria for Multiple Sclerosis Diagnosis: Marcello Moccia, MD, PhD

"Each MS unit should combine the different tools they have ease to access to make the diagnosis of MS. If they are not able to, they can refer the small subset of patients with suspected MS to other centers, but I think we need to be extremely pragmatic.”

Although the therapeutic landscape has constantly evolved, the effect on the use of various disease modifying treatments (DMTs) sequences in multiple sclerosis (MS) has been largely unexplored, specifically in relation to subsequent burden in healthcare systems. A newly presented study revealed that one of the most-frequently prescribed DMTs was ocrelizumab (Ocrevus; Roche), the only FDA-approved medication for both relapsing and progressive forms of MS. Between 2018 and 2022, 28.8% of the prescribed treatments for patients with MS were ocrelizumab, supporting its relevance in clinical routine.

In the study, investigators included 3868 patients with MS from southern Italy who either received their first DMT or switch DMT prescriptions. In the study, ocrelizumab was associated with the highest persistence and adherence, and the costs were lower compared with those of other highly active DMTs. These results were presented at the 

, September 18-20, in Copenhagen, Denmark, by lead author Marcello Moccia, MD, PhD, who also participated as speaker in a scientific session focused on the practical implementation of new diagnosis criteria for MS. These new criteria will provide clinicians with more guidance for diagnosis to potentially help their patients receive treatment interventions, such as with ocrelizumab, earlier.

At the Congress, Moccia, an assistant professor in the department of molecular medicine and medical biotechnology at the University of Naples, sat down with 

to discuss how the integration of new imaging techniques, such as susceptibility weighted imaging sequences and optic nerve imaging, will impact the diagnosis of MS in clinical practice. Moccia, who also serves as a clinical research fellow at University College London, talked about the primary challenges that will potentially be faced by MS units when adapting to the new MS criteria. Furthermore, he spoke about how MS units can overcome limitations in available resources when implementing these new diagnostic protocols.

REFERENCES
1. Moccia M, Affinito G, Marrazzo G, et al. A 5-year population based study on ocrelizumab within different treatment strategies for multiple sclerosis. Presented at: 2024 ECTRIMS; September 18-20; Copenhagen, Denmark. Abstract P860.

The assistant professor at the University of Naples discussed how implementation of new diagnostic criteria for multiple sclerosis will involve practical adjustments in imaging and diagnostic techniques as well as cultural changes in clinical practice. [WATCH TIME: 4 minutes]

Mikael Cohen, MD, discussed whether radiologically isolated syndrome represents a pre-symptomatic phase of multiple sclerosis based on a hot topic session held at the 2024 ECTRIMS Congress

Understanding Radiologically Isolated Syndrome as Either Presymptomatic MS or an Independent Condition: Mikael Cohen, MD

"The reason for the first brain MRI does not influence the risk of conversion to [multiple sclerosis] and does not have a real impact on the follow-up of the patients."

Prior research shows that radiologically isolated syndrome (RIS) is clinically defined by the incidental finding of MRI lesions suggestive of multiple sclerosis (MS) among patients who had an MRI scan for an unrelated reason and who had a normal neurological examination. In some recent studies, findings suggested that subtle abnormalities could be identified in patients with MS who had an Expanded Disability Status Scale of 0 using more challenging tasks than the traditional examination; however, little evidence was available on the RIS patient population.

In a recent study presented at the recently concluded 

, September 18-20, in Copenhagen, Denmark, findings demonstrated the usefulness of digital tools in revealing subtle neurological abnormalities in patients with RIS compared with healthy controls. Presented by lead author 

, and colleagues, these results provided evidence of how fast and efficiently accessible tools can unveil abnormalities in patients with a normal traditional examination, suggesting that digital neurological assessment could also be used in other neurological conditions.

Cohen, a neurologist of the MS Center at the University Hospital Center of Nice in France, also participated as a speaker in a hot topic session titled “Prodromal MS and radiologically isolated syndromes,” which debated the question whether RIS is presymptomatic MS. At the Congress, Cohen sat down with 

 in an interview to dive deeper into a discussion on how the current research differentiates between RIS and early MS in clinical practice. He also talked about the diagnostic challenges that arise in identifying subtle neurological abnormalities in patients with RIS. Furthermore, he spoke about how recent clinical trials influence treatment approaches for RIS and its potential conversion to MS.

REFERENCES
1. Cohen M, et al. Exploring the radiologically isolated syndrome through digital biomarkers: what’s the real definition of a normal neurological examination? normal neurological examination?. Presented at: 2024 ECTRIMS; September 18-20; Copenhagen, Denmark. Abstract P288. 

The neurologist at the University Hospital Center of Nice discussed whether radiologically isolated syndrome represents a pre-symptomatic phase of multiple sclerosis based on a hot topic session held at the 2024 ECTRIMS Congress. [WATCH TIME: 4 minutes]

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