Back to resultsLong-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SR57667B
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer disease, nerve growth factors, Clinical Trial
Eligibility 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00285077
Brief Title
Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease
Official Title
Long-Term Safety Extension of Phase II Study EFC5286 of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer disease, nerve growth factors, Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
390 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SR57667B
Primary Outcome Measure Information:
Title
Adverse events recorded quarterly.
Secondary Outcome Measure Information:
Title
ADAS-cog, CDR, MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2,6,9 and 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge GAUTHIER, MD
Organizational Affiliation
Scientific Advisory Committee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jean-Marc ORGOGOZO, MD
Organizational Affiliation
Scientific Advisory Committee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Philip SCHELTENS, MD
Organizational Affiliation
Scientific Advisory Committee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bengt WINBLAD, MD
Organizational Affiliation
Scientific Advisory Committee
Official's Role
Study Chair
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Horslholm
Country
Denmark
Facility Name
Sanofi-Aventis Administrative Office
City
Helsinki
Country
Finland
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis Administrative Office
City
Bromma
Country
Sweden
12. IPD Sharing Statement
Links:
URL
http://www.sanofi-aventis.com
Description
Related Info
Learn more about this trial
Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease
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