Clinical Trial Design in Alzheimer's Disease

Our understanding of Alzheimer's disease (AD) has drastically improved during the past decade as multiple large-scale studies have been implemented. These studies try to provide a large data set of markers and characteristics of patients with AD. The complexity of these factors and the disease itself have hindered the introduction of novel therapeutic strategies for patients with AD and the success rate of clinical trials in AD is significantly low. We propose the idea of implementing future clinical trials in AD in a more specified population of AD patients based on the mechanism of action of the drug candidate, stage of the disease, and markers involved in the pathogenesis and severity of the disease. The derived results of such trials will not have the problems of doing a post hoc analysis, and although it may harm the generalizability of the results, we may find novel and effective treatment approaches for AD patients with similar characteristics.