Current Alzheimer's disease clinical trials: methods and placebo outcomes.

ABSTRACT:

Background

Eighteen-month-long randomized, placebo-controlled clinical trials are common for phase II and phase III drug development for Alzheimer's disease (AD). Yet, no 18-month trial has shown statistically significant outcomes favoring the test drug. We examined characteristics and underlying assumptions of these trials by assessing the placebo groups.

Methods

We searched the clinicaltrials.gov registry for randomized, placebo-controlled clinical trials for AD of at least 18-month duration and extracted demographic, clinical, and trials characteristics, and change in main outcomes from the placebo groups. We obtained additional information from presentations, abstracts, publications, and sponsors.

Results

Of 23 trials identified, 11 were completed and had baseline

SUBMITTER: Schneider LS 

PROVIDER: S-EPMC3321732 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature