STATISTICAL ISSUES IN PREVENTION AND THERAPEUTIC TRIALS OF ALZHEIMER-DISEASE

Relatively little attention has been given to the proper design and st atistical analysis of prevention and therapeutic trials of Alzheimer d isease (AD). A number of important methodological issues arise in stud ies of AD that do not typically arise in studies of other chronic dise ases. These issues include: the definition of the primary study endpoi nt that is simple to measure and easy to interpret; proper design of t rials that take into account that the patient population is very old; and the proper statistical analysis that addresses the high drop out r ate and the multiple ways of measuring disease severity. Addressing th ese issues will speed the progress of the evaluation of promising comp ounds to prevent and treat AD.