A retrospective analysis of serious adverse events and deaths in U.S.-based lifestyle clinical trials for cognitive health.

ABSTRACT:

Objective

This retrospective analysis examined serious adverse events (SAEs) and deaths in U.S. lifestyle clinical trials aimed at enhancing cognitive health in older adults.

Methods

Data was gathered from trials completed between January 1, 2000, and July 19, 2023, via ClinicalTrials.gov's API.

Results

Among these trials, 76% did not report results. The remaining studies fell into four intervention categories: Cognitive/Behavioral, Exercise/Movement, Diet/Supplement, and Multi-modal. When considering all trial types collectively, the findings suggest that lifestyle clinical trials are generally safe. There was no significant increase in the relative risk of experiencing an SAE in the intervention group compared to the control group. However, in terms of relative risk

SUBMITTER: Key MN 

PROVIDER: S-EPMC10884817 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature