Faculty, Staff and Student Publications

Publication Date

1-1-2025

Journal

The Journal of Prevention of Alzheimer's Disease

DOI

10.1016/j.tjpad.2024.100001

PMID

39800453

PMCID

PMC12183988

PubMedCentral® Posted Date

1-1-2025

PubMedCentral® Full Text Version

Post-print

Abstract

There is growing consensus in the Alzheimer's community that combination therapy will be needed to maximize therapeutic benefits through the course of the disease. However, combination therapy raises complex questions and decisions for study sponsors, from preclinical research through clinical trial design to regulatory, statistical, and operational considerations. In January 2024, the Alzheimer's Drug Discovery Foundation convened an expert advisory board to discuss the key considerations in each of these areas. Experts agreed on the need to prioritize a combination therapy approach that encompasses a wide range of targets associated with aging and the underlying biology of Alzheimer's disease. Progress in combination therapy could be accelerated by leveraging preclinical research and Phase 1 and 2A trials to identify the most promising combinations for further development, exploring repurposed agents with available preclinical and clinical data, building collaborations across sectors to support operational challenges, and planning for the likely impact of anti-amyloid beta-protein monoclonal antibody therapies on future clinical trial designs.

Keywords

Alzheimer Disease, Humans, Clinical Trials as Topic, Drug Discovery, Drug Therapy, Combination, Advisory Committees

Published Open-Access

yes

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