French recommendations for clinical drug trials in cognitive disorders of the elderly

✍ Scribed by Dr. Bernard Michel; Roland Sambuc; Jean-Claude Scotto

• Publisher: John Wiley and Sons
• Year: 1994
• Tongue: English
• Weight: 449 KB
• Volume: 9
• Category: Article
• ISSN: 0885-6230
• DOI: 10.1002/gps.930091009

✦ Synopsis

Abstract

A consensus conference on the topic of clinical drug trials in cognitive disorders of the elderly was held in Marseille on January 28–29, 1993. At the end of this conference, several recommendations were made. Drugs used in trials must be chosen according to solid neurobiological evidence. Clinical trials profoundly alter the relations between the doctor, the patient and his family and this aspect must be taken into account. Clinical trials should be designed to obtain meaningful and useful data in the domains of pharmacology and epidemiology. Patient selection criteria must be defined with strict attention to the nosology of syndromes causing cognitive disorders in the elderly. Objective evaluation tests able to detect subtle drug effects must be carefully chosen according to the requirements of each trial. Whenever possible, laboratory tests should be used in addition to clinical data. The ethical implications of clinical trials in demented patients require special adaptation to satisfy legal requirements.