Early clinical trials in Alzheimer's disease: selection and evaluation of drug candidates.
Clinical research in Alzheimer's disease (AD) is complicated by inadequate understanding of the etiology and pathogenesis of the disorder, lack of good animal models to predict potentially useful compounds, and methodological issues such as the need for new diagnostic tools and validated assessment criteria. These and other issues which are specific to clinical research in AD occur in the larger context of drug development as it is conducted by major pharmaceutical companies throughout the world. This paper begins with a discussion of the scientific and regulatory requirements for establishing the safety and efficacy of new drugs, with emphasis on drug development in the United States and Europe. Compounds used to ameliorate symptoms of AD are emphasized, as most work to date has focused on such drugs. Examples of animal models currently used to choose compounds for clinical testing are presented, as well as other methods and rationales which have been employed in selecting the compounds currently undergoing clinical trials. Finally, issues in clinical assessment specific to the study of patients with AD are addressed.
Reines
S A
SA
Squibb Institute for Medical Research, E.R. Squibb and Sons, Princeton, New Jersey 08540.
D000544:Alzheimer Disease / Q000188:drug therapy*; D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D006801:Humans; D012106:Research