The relationship between study partner type and rate of AE reporting in mild‐to‐moderate AD clinical trials

In randomized clinical trials (RCTs), monitoring adverse events (AE) and serious AE (SAE) is critical to maximize patient safety and trial integrity. There are, however, instances where the propensity to report AEs may differ by participant characteristics, thereby altering the observed safety profile of interventions and the generalizability of safety results. All Alzheimer’s disease (AD) clinical trials require participants to enroll with a study partner (SP), who ensures trial compliance and serves as a source of study data, including data on AEs. We examined AE reporting patterns among AD trial participants by SP type with the hypothesis that the rates of reported AEs and SAEs differ by SP type.