18-Month Study of the Efficacy 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:
NCT00103649
First received: February 11, 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: 1306
Study Start Date: November 2003
Study Completion Date: October 2007
Primary Completion Date: October 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 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
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: NCT00103649

  Hide Study Locations
Locations
United States, Alabama
UAB Memory Disorders Clinic
Birmingham, Alabama, United States, 35294-0017
United States, Arizona
Barrow Neurology Clinics
Phoenix, Arizona, United States, 85013
PsyPharma Clinical Research, Inc.
Phoenix, Arizona, United States, 85050
Radiant Research
Scottsdale, Arizona, United States, 85251
United States, California
Anaheim Research Center
Anaheim, California, United States, 92801
Margolin Brain Institute
Fresno, California, United States, 93720
Coordinated Clinical Research
La Jolla, California, United States, 92037
Senior Clinical Trials, Inc.
Laguna Hills, California, United States, 92653
Pharmacology Research Institute
Newport Beach, California, United States, 92660
Pharmacology Research Institute
Northridge, California, United States, 91324
Pharmacology Research Institute
Riverside, California, United States, 92506
Pacific Research Network
San Diego,, California, United States, 92103
California Neuroscience Research Medical Group
Sherman Oaks, California, United States, 91403
Pacific Research Network
Vista,, California, United States, 92083
United States, Colorado
Radiant Research
Denver, Colorado, United States, 80212
United States, Connecticut
Associated Neurologist
Danbury,, Connecticut, United States, 06810
Geriatric and Adult Psychiatry, LLC
Hamden, Connecticut, United States, 06518
Yale University School of Medicine AD Research Unit
New Haven, Connecticut, United States, 06510
United States, Delaware
Healthcore
Newark, Delaware, United States, 19713-2094
Neurology Associates, PA
Wilmington, Delaware, United States, 19806
United States, Florida
Atlantic Institute of Clinical Research
Daytona Beach, Florida, United States, 32114
Berma Research Group
Hialeah, Florida, United States, 33016
Baumel-Eisner Neuromedical Institute
Miami, Florida, United States
Baumel-Eisner Neuromedical Institute in Miami Beach
Miami, Florida, United States
Miami Research Associates
Miami, Florida, United States, 33173
Anchor Research Center
Naples, Florida, United States, 34102
Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
Clinical Neuroscience Solutions
Orlando, Florida, United States, 32806
Palm Beach Neurological Center
Palm Beach Gardens,, Florida, United States, 33410
Neurology Clinical Research, Inc.
Plantation, Florida, United States, 33324
CNS Clinical Trials
St Petersburg, Florida, United States, 33702
Baumel-Eisner Neuromedical Institute in Miami Beach
Tamarac, Florida, United States
Suncoast Gerontology Center USF
Tampa, Florida, United States, 33617
Meridien Research
Tampa, Florida, United States, 33609
United States, Georgia
Radiant Research
Marietta, Georgia, United States, 30060
Southeastern Geriatric Healthcare
Snellville, Georgia, United States, 30078
United States, Illinois
Chicago Center for Clinical Research
Chicago, Illinois, United States, 60610
Radiant Research Center
Hoffman Estates, Illinois, United States, 60194
United States, Indiana
Elkhart Clinic, LLC
Elkhart,, Indiana, United States, 46514
United States, Iowa
Ruan Neurology
Des Moines, Iowa, United States, 50314
United States, Kentucky
Four Rivers Clinical Research
Paducah, Kentucky, United States, 42003
United States, Louisiana
Louisiana Research Associates
New Orleans, Louisiana, United States, 70114
J. Gary Booker MD
Shreveport,, Louisiana, United States, 71101
United States, Maryland
Clinical Insights
Glen Burnie, Maryland, United States, 21061
United States, Michigan
Summit Research Network Michigan, Inc.
Okemos, Michigan, United States, 48864
Pivotal Research Centers, Detroit Office
Royal Oak,, Michigan, United States, 48073
United States, Minnesota
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
United States, Nevada
Radiant Research
Las Vegas, Nevada, United States, 89146
United States, New Jersey
ClinSearch, Inc.
Kenilworth,, New Jersey, United States, 07033
The Neuroscience Center of Northern New Jersey
Morristown, New Jersey, United States, 07960
Princeton Medical Institute
Princeton,, New Jersey, United States, 08540
Neurology Group of Bergen County
Ridgewood, New Jersey, United States, 07450
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Neurological Association of Albany P.C.
Albany, New York, United States, 12208
Social Psychiatry Research Institute
Brooklyn,, New York, United States, 11235
Parker Jewish Institute for Healthcare and Rehabilitation
Hyde Park,, New York, United States, 11021
Neurobehavioral Research, Inc.
Lawrence, New York, United States, 11559
Behavioral Medical Research of Staten Island
New York, New York, United States, 10305
Eastside Comprehensive Medical Center
New York, New York, United States, 10021
Global Research and Consulting
Olean, New York, United States, 14760
United States, North Carolina
Duke University Medical Center (DUMC) - Dept. of Psychiatry
Durham, North Carolina, United States, 27710
MedARK Clinical Research
Morganton, North Carolina, United States, 28655
Piedmont Medical Research Assoc, Inc.
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
DayStar Clinical Research, Inc.
Akron, Ohio, United States, 44313
North East Ohio Health Services
Beachwood, Ohio, United States, 44122
Valley Medical Primary Care
Centerville, Ohio, United States, 45459
Remington-Davis Clinical Research
Columbus, Ohio, United States, 43215
Triphase Research, Ltd.
Franklin, Ohio, United States, 45005
TriPhase Research
Franklin,, Ohio, United States, 45005
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, United States, 43623
United States, Oregon
Radiant Research Eugene
Eugene, Oregon, United States, 97455
Clinical Research Institute of Southern Oregon
Medford, Oregon, United States, 97504
Summit Research Network Inc
Portland, Oregon, United States, 97210
United States, Pennsylvania
Coatesville VA Medical Center
Coatesville, Pennsylvania, United States, 19320
Pearl Clinical Research
Norristown, Pennsylvania, United States, 19401
Memory Disorders Clinic
Philadelphia, Pennsylvania, United States, 19104
Radiant Research
Philadelphia, Pennsylvania, United States, 19115
Clinical Trials Research Services
Pittsburgh, Pennsylvania, United States, 15206
JRMC Clinical Trials Center
Pittsburgh, Pennsylvania, United States, 15236
United States, Rhode Island
RI Mood and Memory
East Providence, Rhode Island, United States, 02914
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
CNS Healthcare
Memphis, Tennessee, United States, 38119
Vanderbilt University Medical Center - Geriatric Psychiatry
Nashville, Tennessee, United States, 37212
United States, Texas
University of Texas - Southwestern Medical Center at Dallas
Dallas,, Texas, United States, 75390-9129
AD Research Center
Houston, Texas, United States, 77030
Houston Sleep Center
Houston, Texas, United States, 77024
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
North Texas Neurology Research
Wichita Falls, Texas, United States, 76301
United States, Utah
Radiant Research SLC
Salt Lake City, Utah, United States, 84107
United States, Vermont
The Memory Clinic
Bennington,, Vermont, United States, 05201
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
United States, Washington
Internal Medicine Northwest
Tacoma, Washington, United States, 98405
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Dean Foundation
Middleton, Wisconsin, United States, 53562
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
IPC Research
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Glenrose Rehabilitation Hospital
Edmonton,, Alberta, Canada, T5G 0B7
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 3G8
Medical Arts Health Research Group
Penticton, British Columbia, Canada, V2A 5C8
Can-Med Clinical Research Inc.
Victoria, British Columbia, Canada, V8T 5G1
Canada, Manitoba
Winnipeg Clinic
Winnipeg, Manitoba, Canada, R3C 0N2
Winnipeg Clinic
Winnipeg,, Manitoba, Canada, H1T 2H4
Canada, New Brunswick
Davidson Memory Clinic
Moncton,, New Brunswick, Canada, E1C 4B7
St. Joseph's Hospital
Saint John,, New Brunswick, Canada, E2L 3L6
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton,, Ontario, Canada, L8G 5E4
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Parkwood Hospital - Geriatric Medicine
London, Ontario, Canada, N6C 5J1
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Parkinson's & Neurodegenerative Disorders
Ottawa, Ontario, Canada, K1G 4G3
S.C.O. Health Centre
Ottawa,, Ontario, Canada, K1N 5C8
University Health Network - The Toronto
Toronto, Ontario, Canada, M5T 2S8
Toronto Memory Program
Toronto,, Ontario, Canada, M3B 2W7
Canada, Quebec
NeuroSearch Developments Inc
Greenfield Park, Quebec, Canada, J4V 2J2
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2H4
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Quebec Memory & Motor Skills Disorders
Quebec City, Quebec, Canada, G1R 3X5
Institut Universitaire de Geriatrie de Sherbrooke
Sherbrooke, Quebec, Canada, J1J 3H5
Douglas Hospital Research Centre
Verdun, Quebec, Canada, H4H 1R3
Canada, Saskatchewan
Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 1A5
Canada
Centre de Hospitalier Affilie
Quebec, Canada, G1J 1Z4
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: NCT00103649     History of Changes
Other Study ID Numbers: EFC2946, SR57746
Study First Received: February 11, 2005
Last Updated: August 20, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014