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

Authors

Marwan N. Sabbagh, Department of Neurology Alzheimer's and Memory Disorders Division Barrow Neurological Institute St. Joseph's Hospital and Medical Center Phoenix Arizona USA.
Angela Taylor, Lewy Body Dementia Association Lilburn Georgia USA.
Douglas Galasko, University of California San Diego Shiley-Marcos Alzheimer's Disease Research Center and Department of Neurosciences University of California San Diego La Jolla California USA.
James E. Galvin, Comprehensive Center for Brain Health Department of Neurology University of Miami Miller School of Medicine Miami Florida USA.
Jennifer G. Goldman, Parkinson's and Movement Disorders Shirley Ryan Ability Lab and Departments of Physical Medicine and Rehabilitation and Neurology Northwestern University Feinberg School of Medicine Chicago Illinois USA.
James B. Leverenz, Cleveland Alzheimer's Disease Research Center and Cleveland Clinic Center for Brain Health Cleveland Ohio USA.
Kathleen L. Poston, Department of Neurology Stanford University Palo Alto California USA.
Bradley F. Boeve, Mayo Alzheimer's Disease Research Center and Department of Neurology Mayo Clinic Rochester Minnesota USA.
David J. Irwin, Department of Neurology University of Pennsylvania Perelman School of Medicine Philadelphia Pennsylvania USA.
Joseph F. Quinn, Department of Neurology Oregon Health Sciences University Portland Oregon USA.

Document Type

Article

Abstract

UNLABELLED: 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 Disease Assessment Scale-Cognitive Subscale being among the most often used instruments in AD clinical trials. In contrast, there are no validated instruments for use in clinical trials of drugs for the treatment of dementia with Lewy bodies. This poses challenges for drug development because the regulatory pathway to drug approval requires demonstrable efficacy measures. In December 2021, the Lewy Body Dementia Association advisory group met with representatives from the US Food and Drug Administration to discuss the lack of approved drugs and treatments, discernment of efficacy measures, and identification of biomarkers. HIGHLIGHTS: The Lewy Body with Dementia Association convened a listening session with the US Food and Drug Administration on dementia with Lewy bodies (DLB) and clinical trial design.Gaps include DLB-specific measures, alpha synuclein biomarkers, and coexisting pathologies.DLB clinical trial design should focus on clinical value and disease specificity.

Publication Date

1-1-2023

Publication Title

Alzheimer's & dementia (New York, N. Y.)

E-ISSN

2352-8737

Volume

9

Issue

1

First Page

e12375

PubMed ID

36873923

Digital Object Identifier (DOI)

10.1002/trc2.12375

Recommended Citation

Sabbagh, Marwan N.; Taylor, Angela; Galasko, Douglas; Galvin, James E.; Goldman, Jennifer G.; Leverenz, James B.; Poston, Kathleen L.; Boeve, Bradley F.; Irwin, David J.; and Quinn, Joseph F., "Listening session with the US Food and Drug Administration, Lewy Body Dementia Association, and an expert panel" (2023). Neurology. 1478.
https://scholar.barrowneuro.org/neurology/1478