Biostatistics and Alzheimer’s Disease Clinical Trial Design

Alzheimer’s disease (AD) is a complex and challenging disease with a number of important considerations. This module emphasizes the importance of having disease-area knowledge when analyzing and interpreting all outcomes from clinical trials for AD.

The module begins with an overview of the clinical trial design and clinical outcome measures used for AD before covering research of approved treatments, unsuccessful treatments and treatments currently in development. Furthermore, it briefly looks at the importance of the different types of biomarkers as outcome measures in AD trials. Various study considerations and study analysis considerations are also explored. The module then goes on to focus specifically on designing clinical trials in AD for disease modifying therapies, and concludes with a look at a number of important factors to consider when analyzing the literature surrounding risk factors for AD.