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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00285077
First received: January 31, 2006
Last updated: December 22, 2008
Last verified: December 2008

January 31, 2006
December 22, 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 ClinicalTrials.gov Archive Site
ADAS-cog, CDR, MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2,6,9 and 12 months.
Same as current
Not Provided
Not Provided
 
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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
Drug: SR57667B
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
390
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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   Finland,   France,   Germany,   South Africa,   Sweden
 
NCT00285077
LTS5283
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
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
Sanofi
December 2008

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