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

NCT ID: NCT00104013

Last Updated: 2008-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1455 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-11-30

Brief Summary

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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

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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xaliproden (SR57746A)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Neurological Physicians of Arizona, Inc.

Mesa, Arizona, United States

Site Status

Pivotal Research Centers

Mesa, Arizona, United States

Site Status

Pivotal Research Centers

Peoria, Arizona, United States

Site Status

Northwest NeuroSpecialists

Tucson, Arizona, United States

Site Status

Optimum Health Services

Oceanside, California, United States

Site Status

Anderson Clinical Research

Redlands, California, United States

Site Status

Univ. of CT Health Center

Farmington, Connecticut, United States

Site Status

CNS Healthcare

Jacksonville, Florida, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Memory Disorder Center

Pompano Beach, Florida, United States

Site Status

Neurological Center

Fort Wayne, Indiana, United States

Site Status

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Site Status

Hartford Research Group

Florence, Kentucky, United States

Site Status

Lexington Clinic

Lexington, Kentucky, United States

Site Status

LSUHSC Geriatric Psychiatry

New Orleans, Louisiana, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Synergy Medical

Saginaw, Michigan, United States

Site Status

University Medical Center, Dept. of Psychiatry Clinical Trials

Jackson, Mississippi, United States

Site Status

Radiant Research, Inc.

St Louis, Missouri, United States

Site Status

Center For Emotional Fitness

Moorestown, New Jersey, United States

Site Status

Ubhc/Umdnj667

Piscataway, New Jersey, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

The Clinical Trial Center

Jenkintown, Pennsylvania, United States

Site Status

Radiant Research

Greer, South Carolina, United States

Site Status

Alzheimer's Research & Clinical Programs

North Charleston, South Carolina, United States

Site Status

Harmony Research, Inc

Johnson City, Tennessee, United States

Site Status

R/D Clinical Research, Inc.

Lake Jackson, Texas, United States

Site Status

Grayline Clinical Drug Trial

Wichita Falls, Texas, United States

Site Status

The Innovative Clinical Research Center

Alexandria, Virginia, United States

Site Status

Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology"

Norfolk, Virginia, United States

Site Status

National Clinical Research, Inc

Richmond, Virginia, United States

Site Status

sanofi-aventis Australia & New Zealand administrative office

Macquarie Park, New South Wales, , Australia

Site Status

Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Sanofi-Aventis Administrative Office

Causeway Bay, , Hong Kong

Site Status

Sanfoi-Aventis Administrative Office

Milan, , Italy

Site Status

Sanofi-Aventis Administrative Office

Gouda, , Netherlands

Site Status

Sanofi-Aventis Administrative Office

Singapore, , Singapore

Site Status

Sanofi-Aventis Administrative Office

Midrand, , South Africa

Site Status

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Site Status

Sanofi-Aventis Administrative Office

Taipei, , Taiwan

Site Status

Countries

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United States Australia France Hong Kong Italy Netherlands Singapore South Africa Spain Taiwan

Related Links

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Other Identifiers

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SR57746A

Identifier Type: -

Identifier Source: secondary_id

EFC2724

Identifier Type: -

Identifier Source: org_study_id