Safety Profile of a Cognitively Unimpaired Older Population with Elevated Cerebral Amyloid in a 4.5-Year Clinical Trial.

ABSTRACT:

Background

Preclinical Alzheimer's disease is increasingly studied in clinical trials. Although safety signals are routinely monitored in clinical trial populations with Alzheimer's disease, it can be challenging to identify new safety signals against background rates of age-related medical comorbidities.

Objectives

To report detailed safety data from a cognitively unimpaired older population with evidence of elevated cerebral amyloid levels on amyloid positron emission tomography in the placebo arm of a Phase 3 clinical trial.

Design

Phase 3, 4.5-year, multicenter, placebo-controlled trial.

Setting

Placebo data from the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) study.

Participants

Enrolled participants were aged 65-85 years with a

SUBMITTER: Yaari R 

PROVIDER: S-EPMC11266256 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature