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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00285025 |
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.
Condition | Intervention | Phase |
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Alzheimer Disease |
Drug: SR57667B |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 500 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | September 2005 |
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | EFC5286, SR57667B |
Study First Received: | January 31, 2006 |
Last Updated: | January 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00285025 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices |
Alzheimer disease nerve growth factors Clinical Trial |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |