Status:
COMPLETED
Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
Lead Sponsor:
Sanofi
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 patient...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
1455 Patients enrolled
Trial Details
Trial ID
NCT00104013
Start Date
November 1 2003
End Date
November 1 2007
Last Update
August 21 2008
Active Locations (41)
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1
Neurological Physicians of Arizona, Inc.
Mesa, Arizona, United States, 85201
2
Pivotal Research Centers
Mesa, Arizona, United States, 85210
3
Pivotal Research Centers
Peoria, Arizona, United States, 85381
4
Northwest NeuroSpecialists
Tucson, Arizona, United States, 85741-3537