Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00285077
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : December 23, 2008
Information provided by:

January 31, 2006
February 1, 2006
December 23, 2008
March 2004
November 2006   (Final data collection date for primary outcome measure)
Adverse events recorded quarterly.
Same as current
Complete list of historical versions of study NCT00285077 on Archive Site
ADAS-cog, CDR, MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2,6,9 and 12 months.
Same as current
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Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease
Long-Term Safety Extension of Phase II Study EFC5286 of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease

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.

Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
Drug: SR57667B
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2006
November 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   Finland,   France,   Germany,   South Africa,   Sweden
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ICD Study Director, sanofi-aventis
Not Provided
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
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP