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

Last updated: August 20, 2008
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Dementia

Treatment

N/A

Clinical Study ID

NCT00104013
EFC2724
SR57746A
  • Ages > 50
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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-MentalStatus Examination score of 16 to 26 (inclusive)

  • Potential participant may be treated with conventional Alzheimer's diseasetherapy and must be on a stable dose for at least 6 months prior to therandomization and during the entire study period

  • Potential participant must have a reliable caregiver and must be living in acommunity 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 andidentified caregiver

Exclusion

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 thisstudy

Study Design

Total Participants: 1455
Study Start date:
November 01, 2003
Estimated Completion Date:
November 30, 2007

Connect with a study center

  • sanofi-aventis Australia & New Zealand administrative office

    Macquarie Park, New South Wales,
    Australia

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Paris,
    France

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Causeway Bay,
    Hong Kong

    Site Not Available

  • Sanfoi-Aventis Administrative Office

    Milano,
    Italy

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Gouda,
    Netherlands

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Singapore,
    Singapore

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Midrand,
    South Africa

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Barcelona,
    Spain

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Taipei,
    Taiwan

    Site Not Available

  • Neurological Physicians of Arizona, Inc.

    Mesa, Arizona 85201
    United States

    Site Not Available

  • Pivotal Research Centers

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Pivotal Research Centers

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Northwest NeuroSpecialists

    Tucson, Arizona 85741-3537
    United States

    Site Not Available

  • Optimum Health Services

    Oceanside, California 92056
    United States

    Site Not Available

  • Anderson Clinical Research

    Redlands, California 92374
    United States

    Site Not Available

  • Univ. of CT Health Center

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • CNS Healthcare

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34471
    United States

    Site Not Available

  • Memory Disorder Center

    Pompano Beach, Florida 33064
    United States

    Site Not Available

  • Neurological Center

    Fort Wayne, Indiana 46805
    United States

    Site Not Available

  • Vince and Associates Clinical Research

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Hartford Research Group

    Florence, Kentucky 41042
    United States

    Site Not Available

  • Lexington Clinic

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • LSUHSC Geriatric Psychiatry

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Synergy Medical

    Saginaw, Michigan 48602
    United States

    Site Not Available

  • University Medical Center, Dept. of Psychiatry Clinical Trials

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Radiant Research, Inc.

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Center For Emotional Fitness

    Moorestown, New Jersey 08057
    United States

    Site Not Available

  • Ubhc/Umdnj667

    Piscataway, New Jersey 08855
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The Clinical Trial Center

    Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • Radiant Research

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Alzheimer's Research & Clinical Programs

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • Harmony Research, Inc

    Johnson City, Tennessee 37601
    United States

    Site Not Available

  • R/D Clinical Research, Inc.

    Lake Jackson, Texas 77566
    United States

    Site Not Available

  • Grayline Clinical Drug Trial

    Wichita Falls, Texas 76309
    United States

    Site Not Available

  • The Innovative Clinical Research Center

    Alexandria, Virginia 22304
    United States

    Site Not Available

  • Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology"

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • National Clinical Research, Inc

    Richmond, Virginia 23294
    United States

    Site Not Available

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