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Study 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-Aventis
ClinicalTrials.gov Identifier:
NCT00104013
First received: February 18, 2005
Last updated: August 20, 2008
Last verified: August 2008
History of Changes

February 18, 2005
August 20, 2008
November 2003
November 2007   (final data collection date for primary outcome measure)
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
Same as current
Complete list of historical versions of study NCT00104013 on ClinicalTrials.gov Archive Site
Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.
Same as current
 
 
 
Study 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).
 
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)
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1455
November 2007
November 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 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 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
United States,   Australia,   France,   Hong Kong,   Italy,   Netherlands,   Singapore,   South Africa,   Spain,   Taiwan
 
NCT00104013
EFC2724, SR57746A
 
ICD Study Director, sanofi-aventis
Sanofi-Aventis
 
Study Director: ICD CSD Sanofi-Aventis
Sanofi-Aventis
August 2008

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