BEHAVIORAL OUTCOMES IN CLINICAL-TRIALS FOR ALZHEIMER-DISEASE

The use of behavioral scales is an important component in determining efficacy of new drugs in clinical trials for Alzheimer disease (AD). B ehavioral assessment in clinical trials must be sensitive to disease h eterogeneity, disease progression, and drug modification of behavior. Three such scales, the Behavior pathology in Alzheimer's Disease Ratin g Scale (BEHAVE-AD), the Consortium to Establish a Registry for Alzhei mer's Disease (CERAD) Behavior Rating Scale for Dementia (C-BRSD), and the Cohen-Mansfield Agitation Inventory (CMAI), are useful in clinica l trials. The BEHAVE-AD reliably assesses the severity of a range of A D symptoms (7 areas with 25 items) and rates behavioral impact on care givers. The C-BRSD enables reliable assessment of the frequency of beh aviors (8 areas with 48 items) in AD and monitors relevant behaviors t hroughout the course of the disease. However, it does nest assess the impact of behaviors on caregivers. The CMAI focuses on assessment of a gitation and aggression and is compatible with C-BRSD but does not ass ess the impact of agitation on caregivers. A recent trial evaluated th e C-BRSD and the CMAI in more than 300 AD and normal elderly individua ls. Both of these scales discriminated between AD and non-AD patients, were sensitive across disease severity, and could track behavioral ch anges over 12 months of AD progression. The BEHAVE-AD, C-BRSD, and CMA I scales are valid, reliable, rapid to administer, cover relevant beha viors occurring during the course of the disease, and are appropriate for use in AD clinical trials.