Listening session with the US Food and Drug Administration, Lewy Body Dementia Association, and an expert panel

Listening session with the US Food and Drug Administration, Lewy Body Dementia Association, and an expert panel

Abstract The regulatory path for drug approval is increasingly well defined. Drugs for the treatment of Alzheimer disease (AD) need to show statistically significant benefit over placebo with respect to cognitive and functional measures, with the Clinical Dementia Rating scale and Alzheimer's D...

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Bibliographic Details
Main Authors: Marwan N. Sabbagh, Angela Taylor, Douglas Galasko, James E. Galvin, Jennifer G. Goldman, James B. Leverenz, Kathleen L. Poston, Bradley F. Boeve, David J. Irwin, Joseph F. Quinn
Format: Article
Language:English
Published: Wiley 2023-01-01
Series:Alzheimer’s & Dementia: Translational Research & Clinical Interventions
Subjects:
clinical trials
dementia with Lewy bodies
drug development
outcome measures
regulatory pathways
Online Access:https://doi.org/10.1002/trc2.12375

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