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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
  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:


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)
Detailed Description:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 20, 2014