Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00104013
- 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
- 1455
-
Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria
- Mild to moderate degree of severity of dementia as assessed by the Mini-Mental Status Examination score of 16 to 26 (inclusive)
- Potential participant may be treated with conventional Alzheimer's disease therapy and must be on a 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 (34)
Neurological Center
🇺🇸Fort Wayne, Indiana, United States
Synergy Medical
🇺🇸Saginaw, Michigan, United States
CNS Healthcare
🇺🇸Jacksonville, Florida, United States
Vince and Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
Radiant Research, Inc.
🇺🇸St. Louis, Missouri, United States
Neurological Physicians of Arizona, Inc.
🇺🇸Mesa, Arizona, United States
Univ. of CT Health Center
🇺🇸Farmington, Connecticut, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Northwest NeuroSpecialists
🇺🇸Tucson, Arizona, United States
LSUHSC Geriatric Psychiatry
🇺🇸New Orleans, Louisiana, United States
Hartford Research Group
🇺🇸Florence, Kentucky, United States
Center For Emotional Fitness
🇺🇸Moorestown, New Jersey, United States
Pivotal Research Centers
🇺🇸Peoria, Arizona, United States
Alzheimer's Research & Clinical Programs
🇺🇸North Charleston, South Carolina, United States
Harmony Research, Inc
🇺🇸Johnson City, Tennessee, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
sanofi-aventis Australia & New Zealand administrative office
🇦🇺Macquarie Park, New South Wales, Australia
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Optimum Health Services
🇺🇸Oceanside, California, United States
Memory Disorder Center
🇺🇸Pompano Beach, Florida, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
The Clinical Trial Center
🇺🇸Jenkintown, Pennsylvania, United States
Sanfoi-Aventis Administrative Office
🇮🇹Milano, Italy
University Medical Center, Dept. of Psychiatry Clinical Trials
🇺🇸Jackson, Mississippi, United States
The Innovative Clinical Research Center
🇺🇸Alexandria, Virginia, United States
Ubhc/Umdnj667
🇺🇸Piscataway, New Jersey, United States
Lexington Clinic
🇺🇸Lexington, Kentucky, United States
National Clinical Research, Inc
🇺🇸Richmond, Virginia, United States
Grayline Clinical Drug Trial
🇺🇸Wichita Falls, Texas, United States
Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology"
🇺🇸Norfolk, Virginia, United States
Sanofi-Aventis Administrative Office
🇨🇳Taipei, Taiwan
Radiant Research
🇺🇸Greer, South Carolina, United States