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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00104013
First received: February 18, 2005
Last updated: August 20, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Alzheimer Disease
Drug: xaliproden (SR57746A)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.

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

Enrollment: 1455
Study Start Date: November 2003
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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 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
  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: NCT00104013

  Hide Study Locations
Locations
United States, Arizona
Pivotal Research Centers
Mesa, Arizona, United States, 85210
Neurological Physicians of Arizona, Inc.
Mesa, Arizona, United States, 85201
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
Mayo Clinic
Jacksonville, Florida, United States, 32224
CNS Healthcare
Jacksonville, Florida, United States, 32216
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
Ubhc/Umdnj667
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
Australia
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
France
Sanofi-Aventis Administrative Office
Paris, France
Hong Kong
Sanofi-Aventis Administrative Office
Causeway Bay, Hong Kong
Italy
Sanfoi-Aventis Administrative Office
Milano, Italy
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Singapore
Sanofi-Aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00104013     History of Changes
Other Study ID Numbers: EFC2724, SR57746A
Study First Received: February 18, 2005
Last Updated: August 20, 2008
Health Authority: United States: Food and Drug Administration

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 October 29, 2014