THERAPEUTIC TRIALS IN ALZHEIMERS-DISEASE - SELECTION RECRUITMENT AND STRATIFICATION

Therapeutic trials conducted in Alzheimer's disease have benefited fro m the standardization of diagnostic criteria based on internationally recognized scales (DSM III-R, NINCDS - ADRDA) which ensure more valid inclusions. Well specified exclusion criteria are also of the utmost i mportance, in particular depression, vascular dementia and concomitant psychotropic drugs. Cognitive and/or functional scales allow an appre ciation of the severity of the disease. Due to the heterogeneity of Al zheimer's disease stratification methods on identified prognostic fact ors i.e. aphasia, extrapyramidal symptoms should be performed. Selecti on of responders during an enrichment phase has still to be discussed. Multicentric studies become imperative because of the large number of patients required and the difficulties in selecting the adequate pati ents. These raise the issues of investigators' experience, coordinatio n and between center variability.