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

NCT00103649 | Completed Phase 3

• 2 other identifiers: EFC2946SR57746
• Study Type: interventional
• Target: 1,306
• Locations: 2 countries
• Sites: 121

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).

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

xaliproden (SR57746A) DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (121)

UAB Memory Disorders Clinic

Birmingham, Alabama, 35294-0017, United States

Location

Barrow Neurology Clinics

Phoenix, Arizona, 85013, United States

Location

PsyPharma Clinical Research, Inc.

Phoenix, Arizona, 85050, United States

Location

Radiant Research

Scottsdale, Arizona, 85251, United States

Location

Anaheim Research Center

Anaheim, California, 92801, United States

Location

Margolin Brain Institute

Fresno, California, 93720, United States

Location

Coordinated Clinical Research

La Jolla, California, 92037, United States

Location

Senior Clinical Trials, Inc.

Laguna Hills, California, 92653, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Pharmacology Research Institute

Northridge, California, 91324, United States

Location

Pharmacology Research Institute

Riverside, California, 92506, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

California Neuroscience Research Medical Group

Sherman Oaks, California, 91403, United States

Location

Pacific Research Network

Vista, California, 92083, United States

Location

Radiant Research

Denver, Colorado, 80212, United States

Location

Associated Neurologist

Danbury, Connecticut, 06810, United States

Location

Geriatric and Adult Psychiatry, LLC

Hamden, Connecticut, 06518, United States

Location

Yale University School of Medicine AD Research Unit

New Haven, Connecticut, 06510, United States

Location

Healthcore

Newark, Delaware, 19713-2094, United States

Location

Neurology Associates, PA

Wilmington, Delaware, 19806, United States

Location

Atlantic Institute of Clinical Research

Daytona Beach, Florida, 32114, United States

Location

Berma Research Group

Hialeah, Florida, 33016, United States

Location

Miami Research Associates

Miami, Florida, 33173, United States

Location

Baumel-Eisner Neuromedical Institute in Miami Beach

Miami, Florida, United States

Location

Baumel-Eisner Neuromedical Institute

Miami, Florida, United States

Location

Anchor Research Center

Naples, Florida, 34102, United States

Location

Segal Institute for Clinical Research

North Miami, Florida, 33161, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32806, United States

Location

Palm Beach Neurological Center

Palm Beach Gardens, Florida, 33410, United States

Location

Neurology Clinical Research, Inc.

Plantation, Florida, 33324, United States

Location

CNS Clinical Trials

St. Petersburg, Florida, 33702, United States

Location

Baumel-Eisner Neuromedical Institute in Miami Beach

Tamarac, Florida, United States

Location

Meridien Research

Tampa, Florida, 33609, United States

Location

Suncoast Gerontology Center USF

Tampa, Florida, 33617, United States

Location

Radiant Research

Marietta, Georgia, 30060, United States

Location

Southeastern Geriatric Healthcare

Snellville, Georgia, 30078, United States

Location

Chicago Center for Clinical Research

Chicago, Illinois, 60610, United States

Location

Radiant Research Center

Hoffman Estates, Illinois, 60194, United States

Location

Elkhart Clinic, LLC

Elkhart, Indiana, 46514, United States

Location

Ruan Neurology

Des Moines, Iowa, 50314, United States

Location

Four Rivers Clinical Research

Paducah, Kentucky, 42003, United States

Location

Louisiana Research Associates

New Orleans, Louisiana, 70114, United States

Location

J. Gary Booker MD

Shreveport, Louisiana, 71101, United States

Location

Clinical Insights

Glen Burnie, Maryland, 21061, United States

Location

Summit Research Network Michigan, Inc.

Okemos, Michigan, 48864, United States

Location

Pivotal Research Centers, Detroit Office

Royal Oak, Michigan, 48073, United States

Location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Radiant Research

Las Vegas, Nevada, 89146, United States

Location

ClinSearch, Inc.

Kenilworth, New Jersey, 07033, United States

Location

The Neuroscience Center of Northern New Jersey

Morristown, New Jersey, 07960, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Neurology Group of Bergen County

Ridgewood, New Jersey, 07450, United States

Location

Lovelace Scientific Resources

Albuquerque, New Mexico, 87108, United States

Location

Neurological Association of Albany P.C.

Albany, New York, 12208, United States

Location

Social Psychiatry Research Institute

Brooklyn, New York, 11235, United States

Location

Parker Jewish Institute for Healthcare and Rehabilitation

Hyde Park, New York, 11021, United States

Location

Neurobehavioral Research, Inc.

Lawrence, New York, 11559, United States

Location

Eastside Comprehensive Medical Center

New York, New York, 10021, United States

Location

Behavioral Medical Research of Staten Island

New York, New York, 10305, United States

Location

Global Research and Consulting

Olean, New York, 14760, United States

Location

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

Durham, North Carolina, 27710, United States

Location

MedARK Clinical Research

Morganton, North Carolina, 28655, United States

Location

Piedmont Medical Research Assoc, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

DayStar Clinical Research, Inc.

Akron, Ohio, 44313, United States

Location

North East Ohio Health Services

Beachwood, Ohio, 44122, United States

Location

Valley Medical Primary Care

Centerville, Ohio, 45459, United States

Location

Remington-Davis Clinical Research

Columbus, Ohio, 43215, United States

Location

Triphase Research, Ltd.

Franklin, Ohio, 45005, United States

Location

TriPhase Research

Franklin, Ohio, 45005, United States

Location

Neurology and Neuroscience Center of Ohio

Toledo, Ohio, 43623, United States

Location

Radiant Research Eugene

Eugene, Oregon, 97455, United States

Location

Clinical Research Institute of Southern Oregon

Medford, Oregon, 97504, United States

Location

Summit Research Network Inc

Portland, Oregon, 97210, United States

Location

Coatesville VA Medical Center

Coatesville, Pennsylvania, 19320, United States

Location

Pearl Clinical Research

Norristown, Pennsylvania, 19401, United States

Location

Memory Disorders Clinic

Philadelphia, Pennsylvania, 19104, United States

Location

Radiant Research

Philadelphia, Pennsylvania, 19115, United States

Location

Clinical Trials Research Services

Pittsburgh, Pennsylvania, 15206, United States

Location

JRMC Clinical Trials Center

Pittsburgh, Pennsylvania, 15236, United States

Location

RI Mood and Memory

East Providence, Rhode Island, 02914, United States

Location

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

Vanderbilt University Medical Center - Geriatric Psychiatry

Nashville, Tennessee, 37212, United States

Location

University of Texas - Southwestern Medical Center at Dallas

Dallas, Texas, 75390-9129, United States

Location

Houston Sleep Center

Houston, Texas, 77024, United States

Location

AD Research Center

Houston, Texas, 77030, United States

Location

Innovative Clinical Trials

San Antonio, Texas, 78229, United States

Location

North Texas Neurology Research

Wichita Falls, Texas, 76301, United States

Location

Radiant Research SLC

Salt Lake City, Utah, 84107, United States

Location

The Memory Clinic

Bennington, Vermont, 05201, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Internal Medicine Northwest

Tacoma, Washington, 98405, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801, United States

Location

Dean Foundation

Middleton, Wisconsin, 53562, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

IPC Research

Waukesha, Wisconsin, 53188, United States

Location

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

Location

Unknown Facility

Kelowna, British Columbia, V1Y 3G8, Canada

Location

Medical Arts Health Research Group

Penticton, British Columbia, V2A 5C8, Canada

Location

Can-Med Clinical Research Inc.

Victoria, British Columbia, V8T 5G1, Canada

Location

Winnipeg Clinic

Winnipeg, Manitoba, H1T 2H4, Canada

Location

Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Davidson Memory Clinic

Moncton, New Brunswick, E1C 4B7, Canada

Location

St. Joseph's Hospital

Saint John, New Brunswick, E2L 3L6, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8G 5E4, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Parkwood Hospital - Geriatric Medicine

London, Ontario, N6C 5J1, Canada

Location

Parkinson's & Neurodegenerative Disorders

Ottawa, Ontario, K1G 4G3, Canada

Location

S.C.O. Health Centre

Ottawa, Ontario, K1N 5C8, Canada

Location

Toronto Memory Program

Toronto, Ontario, M3B 2W7, Canada

Location

University Health Network - The Toronto

Toronto, Ontario, M5T 2S8, Canada

Location

NeuroSearch Developments Inc

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2H4, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Centre de Hospitalier Affilie

Québec, Quebec, G1J 1Z4, Canada

Location

Quebec Memory & Motor Skills Disorders

Québec, Quebec, G1R 3X5, Canada

Location

Institut Universitaire de Geriatrie de Sherbrooke

Sherbrooke, Quebec, J1J 3H5, Canada

Location

Douglas Hospital Research Centre

Verdun, Quebec, H4H 1R3, Canada

Location

Pasqua Hospital

Regina, Saskatchewan, S4T 1A5, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Alzheimer Disease

Interventions

xaliproden

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 11, 2005
• First Posted: February 14, 2005
• Study Start: November 1, 2003
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 21, 2008

Record last verified: 2008-08

Locations

US (97); CA (24)