Numéro |
Therapie
Volume 65, Numéro 4, Juillet-Août 2010
|
|
---|---|---|
Page(s) | 285 - 290 | |
Section | Physiopathologie / Physiopathology | |
DOI | https://doi.org/10.2515/therapie/2010040 | |
Publié en ligne | 21 septembre 2010 |
Physiopathology
Biomarkers for the Early Stages of Clinical Development in Alzheimer’s Disease
1
EA 1046, Faculté de Médecine, Université de Lille II, Département
Universitaire de Pharmacologie, Lille, France
2
ISPED, Inserm U897, Université Victor Segalen Bordeaux 2,
Bordeaux, France
3
Fédération des Maladies du Système Nerveux, Hôpital de la
Pitié-Salpétrière, Paris, France
4
Faculté de Médecine Pierre et Marie Curie, Paris, France
5
Innogenetics, Les
Ulis, France
6
Service de Médecine Nucléaire et Imagerie Fonctionnelle,
CHRU Lille,
France
7
Pôle de Neurologie, Hôpital Salengro, CHRU Lille, France
8
GlaxoSmithKline, Marly le
Roi, France
Correspondence and offprints : Claude Bidaut-Mazel,
GlaxoSmithKline, Direction Médicale, 100 route de Versailles, 78163 Marly le Roi Cedex,
France. E-mail: claude.m.bidaut-mazel@gsk.com;
claudebidaut-mazel@orange.fr
Received:
4
March
2010
Accepted:
25
May
2010
As the failure of several recent Phase III drug development programmes bears witness, the clinical development of “disease-modifying” drugs in Alzheimer’s disease has been confronted with challenging methodological difficulties. Taking into account the financial stakes involved taking drug candidates to the Phase III stage of development, and the risk of investing time and resources fruitlessly in the evaluation of poor candidate drugs, the crucial decision remains whether to proceed from Phase II to Phase III (Go/Nogo). The aim of Phase II studies is to select a molecule likely to be effective in Phase III, but also to eliminate candidate-drugs with an inadequate effect. No consensus currently exists on the best possible design of Phase II studies to inform the Go/Nogo decision optimally. The challenges in choosing the best study design relate to the target population, the end-point criteria used, in particular the use of biomarkers, the experimental protocol, and the study duration. The objective of the Round Table (RT) was to gather the opinions of French experts from the academic, industrial, and regulatory world in order to arrive at a consensus recommendation for the best possible design to be used in Phase II studies in Alzheimer’s disease.
Key words: Alzheimer’s disease / clinical development / biomarker / imaging
© 2010 Société Française de Pharmacologie et de Thérapeutique