Preclinical Alzheimer Disease Drug Development: Early Considerations Based on Phase 3 Clinical Trials.

ABSTRACT: The number of people in the United States living with Alzheimer disease (AD) is growing, resulting in significant clinical and economic impact. Substantial research investment has led to drug development in stages of AD before symptomatic dementia, such as preclinical AD. Although there are no treatments approved for preclinical AD, there are currently 6 phase 3 clinical trials for preclinical AD treatments. In this article, we review these clinical trials and highlight considerations for future coverage decisions. In line with the definition of preclinical AD, enrollment in these trials focuses on cognitively unimpaired patients that are at high risk of AD because of family history and then genetic testing or brain imaging. Enrollment in most of these trials also allows for younger patien

SUBMITTER: Hung A 

PROVIDER: S-EPMC10391091 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature