Impacts of informant replacement in two industry-sponsored Alzheimer's disease clinical trials.

ABSTRACT:

Introduction

In Alzheimer's disease (AD) clinical trials, participants must enroll with a study partner informant who completes validated study instruments. We hypothesized that mid-trial informant replacement impacts study data in industry-sponsored trials.

Methods

We conducted a retrospective analysis of two industry-sponsored AD clinical trials testing semagacestat in mild-to-moderate AD dementia. We assessed the relationships between informant replacement and Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scores. Using generalized estimating equations, we assessed bias and variability using mean (bias) and mean absolute (variance) change in ADCS-ADL between successive visits as outcomes. Both models adjusted for a priori-specified potential c

SUBMITTER: Nishida MK 

PROVIDER: S-EPMC11694524 | biostudies-literature | 2024 Oct-Dec

REPOSITORIES: biostudies-literature