Impact of Study Partner Replacement in Mild Cognitive Impairment Clinical Trials

In Alzheimer’s disease (AD) clinical trials, including trials enrolling patients with Mild Cognitive Impairment (MCI), participants must enroll with a study partner (SP). SPs ensure compliance and provide study data, including assessments of the participant’s cognition and function. Thus, consistency in SP reporting is essential to trial integrity. We quantified the impact of SP replacement on bias and variance of SP‐reported AD Cooperative Study Activities of Daily Living (ADCS‐ADL‐MCI) scores in a large Phase 3 MCI trial.