Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease
Phase 2
Completed
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00285077
- Lead Sponsor
- Sanofi
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 390
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Adverse events recorded quarterly.
- Secondary Outcome Measures
Name Time Method ADAS-cog, CDR, MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2,6,9 and 12 months.
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇸🇪Bromma, Sweden