Study of the Effect of SR57667B in Patients With Alzheimer's Disease
The primary objective is to demonstrate that SR57667B at the dose of 4 mg/day, in comparison to placebo, decreases the decline in cognitive performance and the global clinical decline over 1 year in patients with mild to moderate AD.
Secondary objectives are to assess the effect of SR57667B on functional decline and its safety/tolerability in patients with mild to moderate AD, and to document plasma concentrations of SR57667 in patients with mild to moderate AD.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase II, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease|
- ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.
- MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||September 2005|
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285025
|Study Chair:||Serge GAUTHIER, MD||Scientific Advisory Committee|
|Study Chair:||Jean-Marc ORGOGOZO, MD||Scientific Advisory Committee|
|Study Chair:||Philip SCHELTENS, MD||Scientific Advisory Committee|
|Study Chair:||Bengt WINBLAD, MD||Scientific Advisory Committee|