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

NCT ID: NCT00103649

Last Updated: 2008-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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xaliproden (SR57746A)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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UAB Memory Disorders Clinic

Birmingham, Alabama, United States

Site Status

Barrow Neurology Clinics

Phoenix, Arizona, United States

Site Status

PsyPharma Clinical Research, Inc.

Phoenix, Arizona, United States

Site Status

Radiant Research

Scottsdale, Arizona, United States

Site Status

Anaheim Research Center

Anaheim, California, United States

Site Status

Margolin Brain Institute

Fresno, California, United States

Site Status

Coordinated Clinical Research

La Jolla, California, United States

Site Status

Senior Clinical Trials, Inc.

Laguna Hills, California, United States

Site Status

Pharmacology Research Institute

Newport Beach, California, United States

Site Status

Pharmacology Research Institute

Northridge, California, United States

Site Status

Pharmacology Research Institute

Riverside, California, United States

Site Status

Pacific Research Network

San Diego, California, United States

Site Status

California Neuroscience Research Medical Group

Sherman Oaks, California, United States

Site Status

Pacific Research Network

Vista, California, United States

Site Status

Radiant Research

Denver, Colorado, United States

Site Status

Associated Neurologist

Danbury, Connecticut, United States

Site Status

Geriatric and Adult Psychiatry, LLC

Hamden, Connecticut, United States

Site Status

Yale University School of Medicine AD Research Unit

New Haven, Connecticut, United States

Site Status

Healthcore

Newark, Delaware, United States

Site Status

Neurology Associates, PA

Wilmington, Delaware, United States

Site Status

Atlantic Institute of Clinical Research

Daytona Beach, Florida, United States

Site Status

Berma Research Group

Hialeah, Florida, United States

Site Status

Miami Research Associates

Miami, Florida, United States

Site Status

Baumel-Eisner Neuromedical Institute in Miami Beach

Miami, Florida, United States

Site Status

Baumel-Eisner Neuromedical Institute

Miami, Florida, United States

Site Status

Anchor Research Center

Naples, Florida, United States

Site Status

Segal Institute for Clinical Research

North Miami, Florida, United States

Site Status

Clinical Neuroscience Solutions

Orlando, Florida, United States

Site Status

Palm Beach Neurological Center

Palm Beach Gardens, Florida, United States

Site Status

Neurology Clinical Research, Inc.

Plantation, Florida, United States

Site Status

CNS Clinical Trials

St. Petersburg, Florida, United States

Site Status

Baumel-Eisner Neuromedical Institute in Miami Beach

Tamarac, Florida, United States

Site Status

Meridien Research

Tampa, Florida, United States

Site Status

Suncoast Gerontology Center USF

Tampa, Florida, United States

Site Status

Radiant Research

Marietta, Georgia, United States

Site Status

Southeastern Geriatric Healthcare

Snellville, Georgia, United States

Site Status

Chicago Center for Clinical Research

Chicago, Illinois, United States

Site Status

Radiant Research Center

Hoffman Estates, Illinois, United States

Site Status

Elkhart Clinic, LLC

Elkhart, Indiana, United States

Site Status

Ruan Neurology

Des Moines, Iowa, United States

Site Status

Four Rivers Clinical Research

Paducah, Kentucky, United States

Site Status

Louisiana Research Associates

New Orleans, Louisiana, United States

Site Status

J. Gary Booker MD

Shreveport, Louisiana, United States

Site Status

Clinical Insights

Glen Burnie, Maryland, United States

Site Status

Summit Research Network Michigan, Inc.

Okemos, Michigan, United States

Site Status

Pivotal Research Centers, Detroit Office

Royal Oak, Michigan, United States

Site Status

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

Site Status

Radiant Research

Las Vegas, Nevada, United States

Site Status

ClinSearch, Inc.

Kenilworth, New Jersey, United States

Site Status

The Neuroscience Center of Northern New Jersey

Morristown, New Jersey, United States

Site Status

Princeton Medical Institute

Princeton, New Jersey, United States

Site Status

Neurology Group of Bergen County

Ridgewood, New Jersey, United States

Site Status

Lovelace Scientific Resources

Albuquerque, New Mexico, United States

Site Status

Neurological Association of Albany P.C.

Albany, New York, United States

Site Status

Social Psychiatry Research Institute

Brooklyn, New York, United States

Site Status

Parker Jewish Institute for Healthcare and Rehabilitation

Hyde Park, New York, United States

Site Status

Neurobehavioral Research, Inc.

Lawrence, New York, United States

Site Status

Eastside Comprehensive Medical Center

New York, New York, United States

Site Status

Behavioral Medical Research of Staten Island

New York, New York, United States

Site Status

Global Research and Consulting

Olean, New York, United States

Site Status

Duke University Medical Center (DUMC) - Dept. of Psychiatry

Durham, North Carolina, United States

Site Status

MedARK Clinical Research

Morganton, North Carolina, United States

Site Status

Piedmont Medical Research Assoc, Inc.

Winston-Salem, North Carolina, United States

Site Status

DayStar Clinical Research, Inc.

Akron, Ohio, United States

Site Status

North East Ohio Health Services

Beachwood, Ohio, United States

Site Status

Valley Medical Primary Care

Centerville, Ohio, United States

Site Status

Remington-Davis Clinical Research

Columbus, Ohio, United States

Site Status

Triphase Research, Ltd.

Franklin, Ohio, United States

Site Status

TriPhase Research

Franklin, Ohio, United States

Site Status

Neurology and Neuroscience Center of Ohio

Toledo, Ohio, United States

Site Status

Radiant Research Eugene

Eugene, Oregon, United States

Site Status

Clinical Research Institute of Southern Oregon

Medford, Oregon, United States

Site Status

Summit Research Network Inc

Portland, Oregon, United States

Site Status

Coatesville VA Medical Center

Coatesville, Pennsylvania, United States

Site Status

Pearl Clinical Research

Norristown, Pennsylvania, United States

Site Status

Memory Disorders Clinic

Philadelphia, Pennsylvania, United States

Site Status

Radiant Research

Philadelphia, Pennsylvania, United States

Site Status

Clinical Trials Research Services

Pittsburgh, Pennsylvania, United States

Site Status

JRMC Clinical Trials Center

Pittsburgh, Pennsylvania, United States

Site Status

RI Mood and Memory

East Providence, Rhode Island, United States

Site Status

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Site Status

Avera Research Institute

Sioux Falls, South Dakota, United States

Site Status

CNS Healthcare

Memphis, Tennessee, United States

Site Status

Vanderbilt University Medical Center - Geriatric Psychiatry

Nashville, Tennessee, United States

Site Status

University of Texas - Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

Houston Sleep Center

Houston, Texas, United States

Site Status

AD Research Center

Houston, Texas, United States

Site Status

Innovative Clinical Trials

San Antonio, Texas, United States

Site Status

North Texas Neurology Research

Wichita Falls, Texas, United States

Site Status

Radiant Research SLC

Salt Lake City, Utah, United States

Site Status

The Memory Clinic

Bennington, Vermont, United States

Site Status

Charlottesville Medical Research

Charlottesville, Virginia, United States

Site Status

Internal Medicine Northwest

Tacoma, Washington, United States

Site Status

Wenatchee Valley Medical Center

Wenatchee, Washington, United States

Site Status

Dean Foundation

Middleton, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

IPC Research

Waukesha, Wisconsin, United States

Site Status

Glenrose Rehabilitation Hospital

Edmonton, Alberta, Canada

Site Status

Kelowna, British Columbia, Canada

Site Status

Medical Arts Health Research Group

Penticton, British Columbia, Canada

Site Status

Can-Med Clinical Research Inc.

Victoria, British Columbia, Canada

Site Status

Winnipeg Clinic

Winnipeg, Manitoba, Canada

Site Status

Winnipeg Clinic

Winnipeg, Manitoba, Canada

Site Status

Davidson Memory Clinic

Moncton, New Brunswick, Canada

Site Status

St. Joseph's Hospital

Saint John, New Brunswick, Canada

Site Status

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

St. Joseph's Health Care

London, Ontario, Canada

Site Status

Parkwood Hospital - Geriatric Medicine

London, Ontario, Canada

Site Status

Parkinson's & Neurodegenerative Disorders

Ottawa, Ontario, Canada

Site Status

S.C.O. Health Centre

Ottawa, Ontario, Canada

Site Status

Toronto Memory Program

Toronto, Ontario, Canada

Site Status

University Health Network - The Toronto

Toronto, Ontario, Canada

Site Status

NeuroSearch Developments Inc

Greenfield Park, Quebec, Canada

Site Status

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Centre de Hospitalier Affilie

Québec, Quebec, Canada

Site Status

Quebec Memory & Motor Skills Disorders

Québec, Quebec, Canada

Site Status

Institut Universitaire de Geriatrie de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Douglas Hospital Research Centre

Verdun, Quebec, Canada

Site Status

Pasqua Hospital

Regina, Saskatchewan, Canada

Site Status

Countries

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United States Canada

Related Links

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Other Identifiers

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SR57746

Identifier Type: -

Identifier Source: secondary_id

EFC2946

Identifier Type: -

Identifier Source: org_study_id