18-Month Study of the Efficacy of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00103649
- Lead Sponsor
- Sanofi
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1306
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
- Secondary Outcome Measures
Name Time Method Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.
Trial Locations
- Locations (111)
Neurology Clinical Research, Inc.
🇺🇸Plantation, Florida, United States
Clinical Trials Research Services
🇺🇸Pittsburgh, Pennsylvania, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Senior Clinical Trials, Inc.
🇺🇸Laguna Hills, California, United States
Pharmacology Research Institute
🇺🇸Riverside, California, United States
Healthcore
🇺🇸Newark, Delaware, United States
Coordinated Clinical Research
🇺🇸La Jolla, California, United States
Palm Beach Neurological Center
🇺🇸Palm Beach Gardens,, Florida, United States
Chicago Center for Clinical Research
🇺🇸Chicago, Illinois, United States
California Neuroscience Research Medical Group
🇺🇸Sherman Oaks, California, United States
Pacific Research Network
🇺🇸Vista,, California, United States
Berma Research Group
🇺🇸Hialeah, Florida, United States
Associated Neurologist
🇺🇸Danbury,, Connecticut, United States
Geriatric and Adult Psychiatry, LLC
🇺🇸Hamden, Connecticut, United States
Radiant Research Center
🇺🇸Hoffman Estates, Illinois, United States
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States
Neurology and Neuroscience Center of Ohio
🇺🇸Toledo, Ohio, United States
Neurology Group of Bergen County
🇺🇸Ridgewood, New Jersey, United States
Summit Research Network Michigan, Inc.
🇺🇸Okemos, Michigan, United States
Clinical Insights
🇺🇸Glen Burnie, Maryland, United States
ClinSearch, Inc.
🇺🇸Kenilworth,, New Jersey, United States
DayStar Clinical Research, Inc.
🇺🇸Akron, Ohio, United States
TriPhase Research
🇺🇸Franklin,, Ohio, United States
Clinical Research Institute of Southern Oregon
🇺🇸Medford, Oregon, United States
CNS Healthcare
🇺🇸Memphis, Tennessee, United States
Memorial Hospital of Rhode Island
🇺🇸Pawtucket, Rhode Island, United States
Coatesville VA Medical Center
🇺🇸Coatesville, Pennsylvania, United States
Memory Disorders Clinic
🇺🇸Philadelphia, Pennsylvania, United States
JRMC Clinical Trials Center
🇺🇸Pittsburgh, Pennsylvania, United States
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States
Davidson Memory Clinic
🇨🇦Moncton,, New Brunswick, Canada
IPC Research
🇺🇸Waukesha, Wisconsin, United States
The Memory Clinic
🇺🇸Bennington,, Vermont, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Can-Med Clinical Research Inc.
🇨🇦Victoria, British Columbia, Canada
Internal Medicine Northwest
🇺🇸Tacoma, Washington, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
NeuroSearch Developments Inc
🇨🇦Greenfield Park, Quebec, Canada
Douglas Hospital Research Centre
🇨🇦Verdun, Quebec, Canada
Dean Foundation
🇺🇸Middleton, Wisconsin, United States
University Health Network - The Toronto
🇨🇦Toronto, Ontario, Canada
Quebec Memory & Motor Skills Disorders
🇨🇦Quebec City, Quebec, Canada
Miami Research Associates
🇺🇸Miami, Florida, United States
Innovative Clinical Trials
🇺🇸San Antonio, Texas, United States
Duke University Medical Center (DUMC) - Dept. of Psychiatry
🇺🇸Durham, North Carolina, United States
AD Research Center
🇺🇸Houston, Texas, United States
Minneapolis VA Medical Center
🇺🇸Minneapolis, Minnesota, United States
Social Psychiatry Research Institute
🇺🇸Brooklyn,, New York, United States
Parker Jewish Institute for Healthcare and Rehabilitation
🇺🇸Hyde Park,, New York, United States
Eastside Comprehensive Medical Center
🇺🇸New York, New York, United States
Winnipeg Clinic
🇨🇦Winnipeg, Manitoba, Canada
Global Research and Consulting
🇺🇸Olean, New York, United States
Barrow Neurology Clinics
🇺🇸Phoenix, Arizona, United States
PsyPharma Clinical Research, Inc.
🇺🇸Phoenix, Arizona, United States
Vanderbilt University Medical Center - Geriatric Psychiatry
🇺🇸Nashville, Tennessee, United States
Radiant Research SLC
🇺🇸Salt Lake City, Utah, United States
Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
Summit Research Network Inc
🇺🇸Portland, Oregon, United States
Neurological Association of Albany P.C.
🇺🇸Albany, New York, United States
Pivotal Research Centers, Detroit Office
🇺🇸Royal Oak,, Michigan, United States
Baumel-Eisner Neuromedical Institute
🇺🇸Miami, Florida, United States
Anchor Research Center
🇺🇸Naples, Florida, United States
Remington-Davis Clinical Research
🇺🇸Columbus, Ohio, United States
North East Ohio Health Services
🇺🇸Beachwood, Ohio, United States
Southeastern Geriatric Healthcare
🇺🇸Snellville, Georgia, United States
The Neuroscience Center of Northern New Jersey
🇺🇸Morristown, New Jersey, United States
CNS Clinical Trials
🇺🇸St Petersburg, Florida, United States
J. Gary Booker MD
🇺🇸Shreveport,, Louisiana, United States
MedARK Clinical Research
🇺🇸Morganton, North Carolina, United States
Behavioral Medical Research of Staten Island
🇺🇸New York, New York, United States
Valley Medical Primary Care
🇺🇸Centerville, Ohio, United States
Radiant Research Eugene
🇺🇸Eugene, Oregon, United States
Houston Sleep Center
🇺🇸Houston, Texas, United States
Glenrose Rehabilitation Hospital
🇨🇦Edmonton,, Alberta, Canada
North Texas Neurology Research
🇺🇸Wichita Falls, Texas, United States
Institut Universitaire de Geriatrie de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
S.C.O. Health Centre
🇨🇦Ottawa,, Ontario, Canada
Sir Mortimer B. Davis Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Parkinson's & Neurodegenerative Disorders
🇨🇦Ottawa, Ontario, Canada
Centre de Hospitalier Affilie
🇨🇦Quebec, Canada
St. Joseph's Health Care
🇨🇦London, Ontario, Canada
Toronto Memory Program
🇨🇦Toronto,, Ontario, Canada
Anaheim Research Center
🇺🇸Anaheim, California, United States
Atlantic Institute of Clinical Research
🇺🇸Daytona Beach, Florida, United States
Neurology Associates, PA
🇺🇸Wilmington, Delaware, United States
Baumel-Eisner Neuromedical Institute in Miami Beach
🇺🇸Tamarac, Florida, United States
Segal Institute for Clinical Research
🇺🇸North Miami, Florida, United States
Princeton Medical Institute
🇺🇸Princeton,, New Jersey, United States
Elkhart Clinic, LLC
🇺🇸Elkhart,, Indiana, United States
Lovelace Scientific Resources
🇺🇸Albuquerque, New Mexico, United States
Neurobehavioral Research, Inc.
🇺🇸Lawrence, New York, United States
Triphase Research, Ltd.
🇺🇸Franklin, Ohio, United States
Pearl Clinical Research
🇺🇸Norristown, Pennsylvania, United States
University of Texas - Southwestern Medical Center at Dallas
🇺🇸Dallas,, Texas, United States
RI Mood and Memory
🇺🇸East Providence, Rhode Island, United States
Medical Arts Health Research Group
🇨🇦Penticton, British Columbia, Canada
St. Joseph's Hospital
🇨🇦Saint John,, New Brunswick, Canada
Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
UAB Memory Disorders Clinic
🇺🇸Birmingham, Alabama, United States
Yale University School of Medicine AD Research Unit
🇺🇸New Haven, Connecticut, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Suncoast Gerontology Center USF
🇺🇸Tampa, Florida, United States
Ruan Neurology
🇺🇸Des Moines, Iowa, United States
Louisiana Research Associates
🇺🇸New Orleans, Louisiana, United States
Piedmont Medical Research Assoc, Inc.
🇺🇸Winston-Salem, North Carolina, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Parkwood Hospital - Geriatric Medicine
🇨🇦London, Ontario, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton,, Ontario, Canada
Radiant Research
🇺🇸Philadelphia, Pennsylvania, United States