Comparing recruitment, retention, and safety reporting among geographic regions in multinational Alzheimer's disease clinical trials.

ABSTRACT:

Introduction

Most Alzheimer's disease (AD) clinical trials enroll participants multinationally. Yet, few data exist to guide investigators and sponsors regarding the types of patients enrolled in these studies and whether participant characteristics vary by region.

Methods

We used data derived from four multinational phase III trials in mild to moderate AD to examine whether regional differences exist with regard to participant demographics, safety reporting, and baseline scores on the Mini Mental State Examination (MMSE), the 11-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog11), the Clinical Dementia Rating scale Sum of Boxes (CDR-SB), the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL), and the Neuropsychiatric

SUBMITTER: Grill JD 

PROVIDER: S-EPMC4481112 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature