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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00103649
First received: February 11, 2005
Last updated: August 20, 2008
Last verified: August 2008

February 11, 2005
August 20, 2008
November 2003
October 2007   (final data collection date for primary outcome measure)
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
Not Provided
Complete list of historical versions of study NCT00103649 on ClinicalTrials.gov Archive Site
Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.
Not Provided
Not Provided
Not Provided
 
18-Month Study of the Efficacy of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alzheimer Disease
Drug: xaliproden (SR57746A)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1306
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
NCT00103649
EFC2946, SR57746
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP