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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.
 
ClinicalTrials.gov Identifier: NCT00285077
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : December 23, 2008
Sponsor:
Information provided by:
Sanofi

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: SR57667B Phase 2

Detailed Description:
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Adverse events recorded quarterly.

Secondary Outcome Measures :
  1. ADAS-cog, CDR, MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2,6,9 and 12 months.

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285077


Locations
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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
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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
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Additional Information:

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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00285077    
Other Study ID Numbers: LTS5283
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: December 23, 2008
Last Verified: December 2008
Keywords provided by Sanofi:
Alzheimer disease
nerve growth factors
Clinical Trial
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders