Alzheimer's disease progression by geographical region in a clinical trial setting.

ABSTRACT:

Introduction

To facilitate enrollment and meet local registration requirements, sponsors have increasingly implemented multi-national Alzheimer's disease (AD) studies. Geographic regions vary on many dimensions that may affect disease progression or its measurement. To aid researchers designing and implementing Phase 3 AD trials, we assessed disease progression across geographic regions using placebo data from four large, multi-national clinical trials of investigational compounds developed to target AD pathophysiology.

Methods

Four similarly-designed 76 to 80 week, randomized, double-blind placebo-controlled trials with nearly identical entry criteria enrolled patients aged ≥55 years with mild or moderate NINCDS/ADRDA probable AD. Descriptive analyses were performed for obs

SUBMITTER: Henley DB 

PROVIDER: S-EPMC4481070 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature