ALZHEIMERS-DISEASE - WHAT APPLICATION FOR WHAT INDICATION

For many years, all application dossiers sent to the Ministry of Healt h for use in Alzheimer's disease focused on the correction of cognitiv e disorders. Discussions were centered on the choice of cognitive eval uation scales and psychometric tests. The situation has since evolved and in addition to the cognitive disorders, applications must also con sider daily life activities and comportmental disorders. Animal experi ences remain classical, the use of aged animals not bringing much info rmation and being extremely expensive. Phase I does not need to be mod ified at this stage. Phase however, must be done with extreme methodol ogical rigor, and especially with an evaluation of pertinent clinical benefit in the cognitive and non-cognitive fields. The simple statisti cally significant improvement in one scale or another was not found su fficient by the Commission. The pharmaceutical company there fore has to find the benefit risk ratio that has real therapeutic interest. If this ratio seems pertinent to the Ministry, then phase III studies can be done to confirm longterm efficacy on enough patients. The study of drug action is very interesting to advance research or even in the ap plication dossier, but in all cases, the ratio of pertinent clinical b enefit to the risk of side effects remains the cornerstone of the deci sion.