Application of predictive models in boosting power of Alzheimer's disease clinical trials: A post hoc analysis of phase 3 solanezumab trials.

ABSTRACT:

Background

The ideal participants for Alzheimer's disease (AD) clinical trials would show cognitive decline in the absence of treatment (i.e., placebo arm) and would also respond to the therapeutic intervention.

Objective

To investigate if predictive models can be an effective tool for identifying and excluding people unlikely to show cognitive decline as an enrichment strategy in AD trials.

Method

We used data from the placebo arms of two phase 3, double-blind trials, EXPEDITION and EXPEDITION2. Patients had 18 months of follow-up. Based on the longitudinal data from the placebo arm, we classified participants into two groups: one showed cognitive decline (any negative slope) and the other showed no cognitive decline (slope is zero or positive) on the Alzheimer's Dis

SUBMITTER: Ezzati A 

PROVIDER: S-EPMC8919041 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature