Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer’s Type

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: November 2007

Interventions

  • Drug: xaliproden (SR57746A)

Clinical Trial Outcome Measures

Primary Measures

  • Alzheimer’s Disease assessment scale-cognitive, clinical dementia rating sum of boxes.

Secondary Measures

  • Mini-Mental State Examination, Alzheimer’s Disease assessment scale-activities of daily life.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • ICD Study Director, sanofi-aventis
  • Overall Official(s)
    • ICD CSD, Study Director, Sanofi

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