Study Partner Type and Adverse Event Reporting in Mild-to-Moderate Alzheimer’s Disease Clinical Trials
Year: 2024
Type: article
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 variance estimation. In all regression models, log-transformed total patient years was included. Results: The estimated reporting rates were 2.83 (95% CI: 2.66, 3.02), 1.18 (95% CI: 1.09, 1.28), 0.23 (95% CI: 0.19, 0.27), and 0.28 (95% CI: 0.24, 0.33) events per participant year for grade 1-3 AEs and SAEs, respectively. We estimated that greater number of visits per year was associated with increased reporting for grade 1-2 AEs and SAEs. We did not find evidence to suggest that AE reporting differed by study partner type or by time the study partner spent with the participant. Conclusions: Study partner type and time the study partner spent with the participant did not appear to impact AE reporting. Estimated reporting rates may be useful to evaluate safety in future studies, particularly those with no control arm and similar visit frequencies.
Source: Journal of Alzheimer s Disease
DOI: 10.3233/jad-231283
Authors: Thuy V. Lu, Joshua D. Grill, Daniel L. Gillen, for the Alzheimer’s Disease Cooperative Study
Institution: University of California, Irvine
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: hybrid
Awards: G5062157695, Effects of Alzheimer's disease clinical trial study partners, Alzheimer's Disease Cooperative Study, Statistical Methods for Alzheimer's Research, Collaborative Approach for Asian Americans, Native Hawaiians, and Pacific Islanders Research and Education (CARE) 2.0, The Alzheimer's Disease Research Center at the University of California, Irvine
OpenAlex ID: W4392190666