A New Monoclonal for Alzheimer Disease
Episode 79, Dec 16, 2022, 11:00 AM
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, we spoke with Marwan Sabbagh, MD, FAAN, a 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. In the phase 3 Clarity AD study (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 (P = .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.
Looking for more Alzheimer disease discussion? Check out the NeurologyLive® dementia/Alzheimer clinical focus page: neurologylive.com/clinical/dementia-alzheimer
Episode Breakdown:
In this episode, we spoke with Marwan Sabbagh, MD, FAAN, a 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. In the phase 3 Clarity AD study (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 (P = .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.
Looking for more Alzheimer disease discussion? Check out the NeurologyLive® dementia/Alzheimer clinical focus page: neurologylive.com/clinical/dementia-alzheimer
Episode Breakdown:
- 1:20 – Lecanemab's safety profile from Clarity AD
- 4:15 – Amyloid-related imaging abnormalities and lecanemab use
- 6:40 – The landscape of Alzheimer disease therapeutics
- 8:10 – Neurology News Minute
- 10:15 – What research has revealed about treatment approaches
- 13:00 – How clinical trials have evolved in dementia research
- 14:40 – The possibility of induction therapy in Alzheimer disease
- 16:30 – Looking ahead to the next steps in treatment development
- 18:00 – Progress toward treating Alzheimer disease earlier
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!
Nominate: neurologylive.com/Giants-of-MS
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
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.
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.