Study 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. Identifier: NCT00104013
Recruitment Status : Completed
First Posted : February 21, 2005
Last Update Posted : August 21, 2008
Information provided by:

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1455 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 : November 2007
Actual Study Completion Date : November 2007

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Status Examination score of 16 to 26 (inclusive)
    • Potential participant may be treated with conventional Alzheimer's disease therapy and must be on a 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

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 identifier (NCT number): NCT00104013

  Hide Study Locations
United States, Arizona
Neurological Physicians of Arizona, Inc.
Mesa, Arizona, United States, 85201
Pivotal Research Centers
Mesa, Arizona, United States, 85210
Pivotal Research Centers
Peoria, Arizona, United States, 85381
Northwest NeuroSpecialists
Tucson, Arizona, United States, 85741-3537
United States, California
Optimum Health Services
Oceanside, California, United States, 92056
Anderson Clinical Research
Redlands, California, United States, 92374
United States, Connecticut
Univ. of CT Health Center
Farmington, Connecticut, United States, 06030
United States, Florida
CNS Healthcare
Jacksonville, Florida, United States, 32216
Mayo Clinic
Jacksonville, Florida, United States, 32224
Renstar Medical Research
Ocala, Florida, United States, 34471
Memory Disorder Center
Pompano Beach, Florida, United States, 33064
United States, Indiana
Neurological Center
Fort Wayne, Indiana, United States, 46805
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66211
United States, Kentucky
Hartford Research Group
Florence, Kentucky, United States, 41042
Lexington Clinic
Lexington, Kentucky, United States, 40504
United States, Louisiana
LSUHSC Geriatric Psychiatry
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Synergy Medical
Saginaw, Michigan, United States, 48602
United States, Mississippi
University Medical Center, Dept. of Psychiatry Clinical Trials
Jackson, Mississippi, United States, 39216
United States, Missouri
Radiant Research, Inc.
St. Louis, Missouri, United States, 63141
United States, New Jersey
Center For Emotional Fitness
Moorestown, New Jersey, United States, 08057
Piscataway, New Jersey, United States, 08855
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
The Clinical Trial Center
Jenkintown, Pennsylvania, United States, 19046
United States, South Carolina
Radiant Research
Greer, South Carolina, United States, 29651
Alzheimer's Research & Clinical Programs
North Charleston, South Carolina, United States, 29406
United States, Tennessee
Harmony Research, Inc
Johnson City, Tennessee, United States, 37601
United States, Texas
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
Grayline Clinical Drug Trial
Wichita Falls, Texas, United States, 76309
United States, Virginia
The Innovative Clinical Research Center
Alexandria, Virginia, United States, 22304
Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology"
Norfolk, Virginia, United States, 23507
National Clinical Research, Inc
Richmond, Virginia, United States, 23294
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
Sanofi-Aventis Administrative Office
Paris, France
Hong Kong
Sanofi-Aventis Administrative Office
Causeway Bay, Hong Kong
Sanfoi-Aventis Administrative Office
Milano, Italy
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Sponsors and Collaborators
Study Director: ICD CSD Sanofi

Additional Information:
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00104013     History of Changes
Other Study ID Numbers: EFC2724
First Posted: February 21, 2005    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders