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

August 20, 2008 updated by: Sanofi

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1306

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 11, 2005

First Submitted That Met QC Criteria

February 11, 2005

First Posted (Estimate)

February 14, 2005

Study Record Updates

Last Update Posted (Estimate)

August 21, 2008

Last Update Submitted That Met QC Criteria

August 20, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC2946
  • SR57746

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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