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 Physicians of Arizona, Inc.
🇺🇸Mesa, Arizona, United States
Pivotal Research Centers
🇺🇸Peoria, Arizona, United States
Northwest NeuroSpecialists
🇺🇸Tucson, Arizona, United States
Optimum Health Services
🇺🇸Oceanside, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Univ. of CT Health Center
🇺🇸Farmington, Connecticut, United States
CNS Healthcare
🇺🇸Jacksonville, Florida, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Memory Disorder Center
🇺🇸Pompano Beach, Florida, United States
Scroll for more (24 remaining)Neurological Physicians of Arizona, Inc.🇺🇸Mesa, Arizona, United States