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

Phase 3

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT00103649
• 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

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-02-11
• Study First Submitted QC: 2005-02-11
• Study First Posted: 2005-02-14
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-20
• Last Update Posted: 2008-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1306

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

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 (111)

UAB Memory Disorders Clinic; 🇺🇸 Birmingham, Alabama, United States

Barrow Neurology Clinics; 🇺🇸 Phoenix, Arizona, United States

PsyPharma Clinical Research, Inc.; 🇺🇸 Phoenix, Arizona, United States

Radiant Research; 🇺🇸 Philadelphia, Pennsylvania, United States

Anaheim Research Center; 🇺🇸 Anaheim, California, United States

Margolin Brain Institute; 🇺🇸 Fresno, California, United States

Coordinated Clinical Research; 🇺🇸 La Jolla, California, United States

Senior Clinical Trials, Inc.; 🇺🇸 Laguna Hills, California, United States

Pharmacology Research Institute; 🇺🇸 Riverside, California, United States

Pacific Research Network; 🇺🇸 Vista,, California, United States

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