Recruitment and retention of participant and study partner dyads in two multinational Alzheimer's disease registration trials.

ABSTRACT:

Background

Early study exit is detrimental to statistical power and increases the risk for bias in Alzheimer's disease clinical trials. Previous analyses in early phase academic trials demonstrated associations between rates of trial incompletion and participants' study partner type, with participants enrolling with non-spouse study partners being at greater risk.

Methods

We conducted secondary analyses of two multinational phase III trials of semagacestat, an oral gamma secretase inhibitor, for mild-to-moderate AD dementia. Cox's proportional hazards regression model was used to estimate the relationship between study partner type and the risk of early exit from the trial after adjustment for a priori identified potential confounding factors. Additionally, we used a random

SUBMITTER: Bernstein OM 

PROVIDER: S-EPMC7791680 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature