Study Partner Type and Adverse Event Reporting in Mild-to-Moderate Alzheimer's Disease Clinical Trials.

ABSTRACT:

Background

In randomized clinical trials (RCTs), monitoring adverse events (AEs) and serious AEs (SAEs) is critical. All Alzheimer's disease (AD) RCTs require participants to enroll with a study partner.

Objective

We examined AE reporting rates in mild-to-moderate AD trials and their associations with study partner type.

Methods

We estimated AE reporting rates using placebo data from seven independent RCTs conducted by the Alzheimer's Disease Cooperative Study. We assessed the heterogeneity of reporting rates as a function of visits using generalized estimating equations. In the primary analysis, we tested the hypotheses that the rates of reporting differed by study partner type and time they spent with the participant weekly using Poisson regression with robust varia

SUBMITTER: Lu TV 

PROVIDER: S-EPMC10977362 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature