Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00285077
First received: January 31, 2006
Last updated: December 22, 2008
Last verified: December 2008
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Purpose
The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD).
A secondary objective is to describe the long term progression of Alzheimer's symptoms in patients treated by 4 mg/day of SR57667B.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: SR57667B |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Long-Term Safety Extension of Phase II Study EFC5286 of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Adverse events recorded quarterly.
Secondary Outcome Measures:
- ADAS-cog, CDR, MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2,6,9 and 12 months.
| Enrollment: | 390 |
| Study Start Date: | March 2004 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who have participated in Study EFC5286 and completed the study.
- Patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures specifically for this LTS5283 extension.
Exclusion Criteria:
- Females who are pregnant or breast-feeding.
- Females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-HCG pregnancy test at the screening visit,and must use an acceptable method of birth control.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285077
Locations
| Canada | |
| Sanofi-Aventis Administrative Office | |
| Laval, Canada | |
| Denmark | |
| Sanofi-Aventis Administrative Office | |
| Horslholm, Denmark | |
| Finland | |
| Sanofi-Aventis Administrative Office | |
| Helsinki, Finland | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| Germany | |
| Sanofi-Aventis Administrative Office | |
| Berlin, Germany | |
| South Africa | |
| Sanofi-Aventis Administrative Office | |
| Midrand, South Africa | |
| Sweden | |
| Sanofi-Aventis Administrative Office | |
| Bromma, Sweden | |
Sponsors and Collaborators
Sanofi
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00285077 History of Changes |
| Other Study ID Numbers: | LTS5283 |
| Study First Received: | January 31, 2006 |
| Last Updated: | December 22, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Canada: Health Canada Germany: Ethics Commission |
Keywords provided by Sanofi:
|
Alzheimer disease nerve growth factors Clinical Trial |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013