Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, Daniel Claaseen, MD, MS, a professor of neurology and chief of the Behavioral and Cognitive Neurology Division at Vanderbilt University Medical Center, offered his insight on phase 1/2 data that was recently presented at the International Parkinson and Movement Disorder Society (MDS) Congress on ATH434, an investigational drug in development from Alterity Therapeutics for multiple system atrophy (MSA). He dove into the therapy's mechanism of action and the currently known safety profile and considerations for its use, as well as the next steps in advancing care for patients with MSA as a whole. Looking for more movement disorders discussion? Check out the NeurologyLive® movement disorder clinical focus page. Episode Breakdown: 1:10 – Overviewing the conduct of the phase 1/2 studies 3:00 – Notable findings from data presented at MDS 4:30 – Mechanism of action behind ATH434 8:20 – Neurology News Minute 10:20 – Next steps in ATH434's development 11:15 – Current unmet needs for patients with MSA 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: FDA Removes Partial Hold for Myotonic Dystrophy Agent AOC 1001 FDA Approves Avadel's Sodium Oxybate for Cataplexy or Excessive Daytime Sleepiness in Pedatric Narcolepsy FDA Approves AbbVie’s 24-Hour Foscarbidopa/Foslevodopa Pump for Advanced Parkinson Disease Treatment Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, Daniel Ontaneda, MD, PhD, a staff member of the Cleveland Clinic Mellen Center for Multiple Sclerosis, provided an in-depth overview on the newly announced McDonald criteria to diagnose multiple sclerosis (MS). 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.  Looking for more Multiple sclerosis discussion? Check out the NeurologyLive® multiple sclerosis clinical focus page. Episode Breakdown: 1:10 – Focus and direction of new diagnostic criteria 3:00 – Overviewing specific changes to McDonald criteria 10:50 – Approach to diagnosing pre-MS; treating radiologically isolated syndrome earlier 12:55 – Neurology News Minute 15:10 – Incorporation of new biomarkers, central vein sign, paramagnetic rim lesions, OCT 21:45 – Unanswered questions/challenges left out of the diagnostic criteria 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 Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, Joanne Donovan, MD, PhD, chief medical officer at Edgewise Therapeutics, sat down to discuss the clinical program of EDG-5506, an investigational drug in development for Becker muscular dystrophy, and the recent progress in treating and understanding Becker muscular dystrophy. She spoke on the mechanism of action of the drug, also known as sevasemten, and why the company believes it can be therapeutically beneficial for this patient population. Furthermore, Donovan spoke on the previous failures in drug development for Becker, advances in biomarker detection, and how other trials paved the way for the company's phase 2 study and open label extension, dubbed CANYON (NCT05291091) and GRAND CANYON. Furthermore, she spoke on the ways the clinical community has tried to improve the quality of life for patients with Becker, focusing on approaches and tactics that curve cardiac issues commonly seen in this group.  Looking for more Neuromuscular discussion? Check out the NeurologyLive® neuromuscular clinical focus page. Episode Breakdown: 1:15 – Overview of CANYON study and extension phase  3:50 – Mechanism of action of EDG-5506 6:30 – How previous trial experiences shaped CANYON  10:10 – Neurology News Minute 11:50 – Ongoing challenges with treating and testing drugs for Becker 15:25 – Safety profile of EDG-5506 16:45 – Ways to tackle cardiac issues in Becker 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: Digital Therapeutic CT-132 Meets Primary End Point in Phase 3 Study of Preventive Migraine FDA Supports Alpha-Synuclein Seed Amplification Assay Biomarker for Clinical Trials in Parkinson Disease FDA Approves Subcutaneous Formulation of Ocrelizumab for Relapsing and Progressive Multiple Sclerosis Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, epilepsy expert Imad Najm, MD, PhD, sat down to discuss the upcoming Cleveland Clinic Epilepsy Summit, an educational symposium that takes place September 11-15, in Cleveland, Ohio. Najm, who serves as the director of Cleveland Clinic's Epilepsy Center at the Cleveland Clinic Neurological Institute, spoke about the objectives and goals of the meeting, including updates on sEEG, epilepsy surgery, treatments for drug-resistant epilepsy, and gene therapy. In addition, he provided an overview of the latest advances in epilepsy surgery, genetics, and seizure controlling approaches. Furthermore, he spoke on some of the educational challenges with adjusting to changes in neurosurgery, the potential benefits and limitations of gene therapy, and the future of epilepsy treatment.  Looking for more Epilepsy discussion? Check out the NeurologyLive® Epilepsy clinical focus page. Episode Breakdown: 1:10 – Mission and goals of Epilepsy Summit  3:05 – Overviewing sessions and educational attainment 4:55 – Changes to epilepsy surgery, advances over the years 9:15 – Neurology News Minute 11:50 – Learning curve for understanding new epilepsy surgery tactics 13:50 – Closing thoughts on the upcoming meeting 15:50 – Potential benefits and challenges to gene therapy for epilepsy 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: EMA Accepts Marketing Authorization Application for Huntington Disease Agent Pridopidine BTK Inhibitor Tolebrutinib Slows Disability Progression in Phase 3 HERCULES Study of Non-Relapsing Secondary Progressive MS FDA Accepts Resubmitted New Drug Application for Migraine Treatment AXS-07 Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, Sharon Cohen, MD, a behavioral neurologist, sat down to discuss positive data from an ongoing phase 1 study of mivelsiran (Alnylam Pharmaceuticals), the first investigational RNA interference therapeutic targeting amyloid precursor protein for Alzheimer disease (AD). Cohen, who also serves as the medical director of the Toronto Memory Program at the University of Toronto, discussed the potential of RNA therapeutics for treating AD, the unique mechanism of action of mivelsiran, and some of the early promising safety, efficacy, and pharmacokinetic data observed in the phase 1 trial. In addition, Cohen touched upon the idea of how RNA therapeutics could be used in combination with previously approved novel treatments and the benefits mivelsiran brings with no observed amyloid-related imaging abnormalities. Furthermore, the discussion covered some of the potential of this investigational agent, what to expect in the multi-dose part B of the study, and an additional phase 2 study in cerebral amyloid angiopathy.  Looking for more Alzheimer disease/dementia discussion? Check out the NeurologyLive® Alzheimer disease/dementia clinical focus page. Episode Breakdown: 1:15 – Mechanism of action of mivelsiran and how it can be potentially beneficial in AD 4:15 – Growing knowledge of RNA therapeutics and their impact on neurologic conditions 7:00 – Neurology News Minute 10:10 – Phase 1 study data, including efficacy, safety, biomarker, and pharmacokinetic results 19:20 – How mivelsiran fits with other approved therapies for AD; future goals and directions of the drug 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: FDA Clears Indapta Therapeutics’ IND for Cell Therapy IDP-023 in Progressive Multiple Sclerosis Muscle-Targeting Therapy Apitegromab Effective in Spinal Muscular Atrophy Over 4 Year Period FDA Approves Medtronic’s Deep Brain Stimulation Technology for Asleep Capabilities Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, Phil Jochelson, therapeutic head for Clinical Development Neuroscience at Jazz Pharmaceuticals, sat down to discuss the phase 4 XYLO study, a randomized controlled study evaluating the effects of switching from high-sodium to low-sodium oxybate on blood pressure in patients with narcolepsy. Jochelson gave some insight regarding the conduct of the trial, including end points, objectives, and patient demographics, as well as some of the benefits to studying blood pressure and cardiovascular risks. In addition, he discussed enhancements to narcolepsy care through low-sodium oxybate, the importance of unique studies like XYLO, and the need to educate clinicians on sodium load and its risks.  Looking for more sleep disorders discussion? Check out the NeurologyLive® sleep disorders clinical focus page. Episode Breakdown: 1:15 – Reasons behind the XYLO study and links between high sodium intake and cardiovascular risk 4:45 – Patient demographics; inclusion and exclusion criterias 6:40 – Neurology News Minute 9:25 – Overview of XYLO and determining what a successful study looks like 15:30 – Improved understanding of the benefits of low-sodium oxybate 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: EU Regulatory Review Adopts Negative Opinion of Lecanemab as Treatment for Alzheimer Disease GLP-1 Agonist Liraglutide Shows Protective Effects on Alzheimer Disease in Phase 2 Trial FDA Approves Carbidopa/Levodopa ER Capsules Formulation IPX203 for Parkinson Disease Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, Michael Weiss, chief executive officer of TG Therapeutics, discussed ublituximab (Briumvi), a recently approved anti-CD20 therapy for relapsing multiple sclerosis, and the advantages it brings to patients. Specifically, he talked about the Department of Veteran Affairs' decision to award national contract to ublituximab as the preferred anti-CD20 for this patient population, and how this facilitates greater access to the treatment. In addition, he discussed how the knowledge profile of the agent has grown over time, as well as the additional efforts to gain a better understanding of its efficacy and safety. Furthermore, he spoke on the differences between ublituximab and other approved agents, and why it may be more applicable to certain patients.  Looking for more multiple sclerosis discussion? Check out the NeurologyLive® Multiple sclerosis clinical focus page. Episode Breakdown: 1:05 – Significance of ublituximab awarded national contract as preferred anti-CD20 for relapsing MS 3:30 – Advantages and differences of ublituximab vs approved therapies for MS 11:40 – Neurology News Minute 14:30 – Growing knowledge profile of ublituximab over the years 19:05 – Future plans of ubtlituximab; long-term goals of the therapy 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: Eli Lilly Announces Date for Donanemab FDA AdComm Hearing Patient Death Reported in Phase 2 DAYLIGHT Study of Pfizer’s Gene Therapy for Duchenne ALS Candidate PrimeC Shows Greater Treatment Effect in High-Risk ALS Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, Douglas Wajda, PhD, an assistant professor of neurology at Cleveland State University, discussed a pilot study presented at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting using a functional electrical stimulation approach, Neural Sleeve, to treat gait in MS. Wajda, who has been studying gait in MS for several years, gave clinical insight on the functionality and feasibility of this approach, and the personalized treatment patients can gain from it. He also discussed the pilot study in detail, including the major end points and takeaways from the small group of patients observed.  Looking for more multiple sclerosis discussion? Check out the NeurologyLive® multiple sclerosis clinical focus page. Episode Breakdown: 1:00 – Functionality of Neural Sleeve 2:45 – Feasibility and self-administration of Neural Sleeve 3:50 – Neurology News Minute 5:50 – Greatest clinical takeaways from pilot study 8:15 – Steps in advancing this therapeutic approach 9:45 – Challenges with gait in MS and personalizing treatment methods 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: Gene Therapy LX2006 Positively Impacts Cardiac Biomarkers of Friedreich Ataxia, Clinical Data Show Buntanetap Transitioning to Crystal Form Following FDA Go-Ahead Endo Voluntarily Recalls One Lot of Clonazepam Tablets Following Mislabeling Error Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, Sameea Husain-Wilson, DO, a movement disorder specialist at the Marcus Neuroscience Institute of Baptist Health, provided clinical perspective on the use of the Syn-One diagnostic test for patients with Parkinson disease (PD). She gave an overview of how the test is utilized in clinic, ways to interpret results, and the right personnel needed to ensure an accurate diagnosis. In addition, she provided clarity on the role of alpha-synuclein in PD, the advances in research in this area, and how the test incorporates this prominent biomarker. Furthermore, Husain-Wilson detailed some of the next steps in further optimizing the test in clinical settings, highlighting the importance of other non-movement disorder specialists who will play a major role in the diagnostic evaluation of future patients with PD. Looking for more movement disorder discussion? Check out the NeurologyLive® movement disorder clinical focus page. Episode Breakdown: 1:10 – Step by step process on how Syn-One test is used; considerations after process is done 3:15 – How the test differentiates PD from other neurodegenerative disorders 9:50 – Neurology News Minute 12:20 – Value and role in assessing alpha-synuclein in PD 14:50 – Ways to further optimize Syn-One going forward 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: FDA Approves Eli Lilly's Donanemab for Early Symptomatic Alzheimer Disease Buntanetap Improves Motor, Nonmotor and Cognitive Symptoms of Parkinson Disease in Phase 3 Study Gene Therapy AMT-130 Slows Huntington Disease Progression in Interim Phase 1/2 Trials Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

Welcome to this special episode of the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. For major FDA decisions in the field of neurology, we release short special episodes to offer a snapshot of the news, including the main takeaways for the clinical community, as well as highlights of the efficacy and safety profile of the agent in question. In this episode, we're covering the recent approval of donanemab as a new treatment for adults with early symptomatic Alzheimer disease (AD). Marketed as Kisunla, donanemab's approval marks the third antiamyloid therapy to get FDA greenlight for early-stage AD, following the controversial approval of aducanumab (Aduhelm; Biogen) in 2021 and lecanemab (Leqembi; Eisai) in 2023. Donanemab, administered as a 350 mg/20 mL once-monthly injection for intravenous infusion, had its approval supported by the phase 3 TRAILBLAZER-ALZ-2 trial (NCT04437511), a large-scale, double-blind, placebo-controlled trial that featured 1736 patients with early-stage AD. Following the approval, NeurologyLive sat down with Joel Salinas, MD, MBA, a behavioral neurologist at NYU Langone and clinical assistant professor in the department of neurology at the NYU Grossman School of Medicine. Salinas, who also serves as the chief medical officer at Isaac Health, discussed the positive impacts of the approval, the importance of patient selection for the medication, and how clinicians should discuss its benefits and harms to patients. In addition, he commented on how approvals like donanemab continue to carry momentum in the AD field going forward.  For more of NeurologyLive's coverage of donanemab's approval, head here: FDA Approves Eli Lilly's Donanemab for Early Symptomatic Alzheimer Disease Episode Breakdown: 2:10 – Positive downstream impacts of donanemab's approval 4:20 – Considerations and caution with prescribing donanemab 6:05 – Salinas on patient-clinician conversations about AD treatments 8:00 – Closing remarks and continued progress in AD field Thanks for listening to the NeurologyLive Mind Moments podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.