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

August 20, 2008 updated by: Sanofi

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1455

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Macquarie Park, New South Wales, Australia
        • sanofi-aventis Australia & New Zealand administrative office
  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office
  • Hong Kong
      • Causeway Bay, Hong Kong
        • Sanofi-Aventis Administrative Office
  • Italy
      • Milano, Italy
        • Sanfoi-Aventis Administrative Office
  • Netherlands
      • Gouda, Netherlands
        • Sanofi-Aventis Administrative Office
  • Singapore
      • Singapore, Singapore
        • Sanofi-Aventis Administrative Office
  • South Africa
      • Midrand, South Africa
        • Sanofi-Aventis Administrative Office
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office
  • Taiwan
      • Taipei, Taiwan
        • Sanofi-Aventis Administrative Office
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Pivotal Research Centers
      • Mesa, Arizona, United States, 85201
        • Neurological Physicians of Arizona, Inc.
      • Peoria, Arizona, United States, 85381
        • Pivotal Research Centers
      • Tucson, Arizona, United States, 85741-3537
        • Northwest NeuroSpecialists
    • California
      • Oceanside, California, United States, 92056
        • Optimum Health Services
      • Redlands, California, United States, 92374
        • Anderson Clinical Research
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Univ. of CT Health Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Jacksonville, Florida, United States, 32216
        • CNS Healthcare
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Pompano Beach, Florida, United States, 33064
        • Memory Disorder Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Neurological Center
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Vince and Associates Clinical Research
    • Kentucky
      • Florence, Kentucky, United States, 41042
        • Hartford Research Group
      • Lexington, Kentucky, United States, 40504
        • Lexington Clinic
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSUHSC Geriatric Psychiatry
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Saginaw, Michigan, United States, 48602
        • Synergy Medical
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University Medical Center, Dept. of Psychiatry Clinical Trials
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Radiant Research, Inc.
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • Center for Emotional Fitness
      • Piscataway, New Jersey, United States, 08855
        • Ubhc/Umdnj667
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Radiant Research
      • North Charleston, South Carolina, United States, 29406
        • Alzheimer's Research & Clinical Programs
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Harmony Research, Inc
    • Texas
      • Lake Jackson, Texas, United States, 77566
        • R/D Clinical Research, Inc.
      • Wichita Falls, Texas, United States, 76309
        • Grayline Clinical Drug Trial
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • The Innovative Clinical Research Center
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology"
      • Richmond, Virginia, United States, 23294
        • National Clinical Research, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.

Secondary Outcome Measures

Outcome Measure
Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 18, 2005

First Submitted That Met QC Criteria

February 18, 2005

First Posted (Estimate)

February 21, 2005

Study Record Updates

Last Update Posted (Estimate)

August 21, 2008

Last Update Submitted That Met QC Criteria

August 20, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC2724
  • SR57746A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe