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18-Month Study of the Efficacy of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

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: NCT00103649
Recruitment Status : Completed
First Posted : February 14, 2005
Last Update Posted : August 21, 2008
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:
The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: xaliproden (SR57746A) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
Study Start Date : November 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

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. Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.

Secondary Outcome Measures :
  1. Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.

Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria

    • Mild to moderate degree of severity of dementia as assessed by the Mini-Mental State Examination score of 16 to 26 (inclusive)
    • Potential participant may be treated with conventional Alzheimer's disease therapy and must be on stable dose for at least 6 months prior to the randomization and during the entire study period
    • Potential participant must have a reliable caregiver and must be living in a community or in an assisted living facility
    • Mother tongue is English, Spanish or French (oral and written fluency)
    • Signed informed consent from potential participant or legal representative and identified caregiver

Exclusion Criteria:

  • Potential participant with any other cause of dementia.
  • Potential participant with serious health problems other than Alzheimer's disease
  • Use of an investigational drug within two months prior to randomization or during this study
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): NCT00103649


Locations
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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: ICD CSD Sanofi
More Information
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Additional Information:

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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00103649    
Other Study ID Numbers: EFC2946
SR57746
First Posted: February 14, 2005    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008
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
Xaliproden
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs