Clinical experiences and methodologic challenges in conducting clinical trials on the behavioral disturbances of dementia.

Abstract

With a world population increasing in size and age, the number of elderly people with behavioral disturbances in dementia (BDD) is becoming an increasing problem. The burden of caring for someone with BDD may be so great that it leads to premature institutionalization of the patient. Few clinical trials have focused on noncognitive behavioral symptoms in this group of elderly patients, and little is known about the efficacy of drugs against these symptoms. The pharmaceutical companies have recently begun to assess different medications, but clinical trials in the elderly present a variety of problems not encountered in other patient populations. This article describes how the administration, initiation, logistics, finances, and methodology of such trials must be carefully assessed. Consideration of these factors together with improved definitions of behavioral symptoms and the advances in medication in this area should lead to an improvement in the treatment and management of behavioral disorders in the elderly.