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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,455

participants targeted

Target at P75+ for phase_3 alzheimer-disease

Timeline

Completed

Started Nov 2003

Typical duration for phase_3 alzheimer-disease

Geographic Reach

10 countries

41 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

Study Start

First participant enrolled

November 1, 2003

Completed

1.3 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2005

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed

Last Updated

August 21, 2008

Status Verified

August 1, 2008

Enrollment Period

4 years

First QC Date

February 18, 2005

Last Update Submit

August 20, 2008

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

xaliproden (SR57746A)DRUG

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sanofilead

Study Sites (41)

Neurological Physicians of Arizona, Inc.

Mesa, Arizona, 85201, United States

Location

Pivotal Research Centers

Mesa, Arizona, 85210, United States

Location

Pivotal Research Centers

Peoria, Arizona, 85381, United States

Location

Northwest NeuroSpecialists

Tucson, Arizona, 85741-3537, United States

Location

Optimum Health Services

Oceanside, California, 92056, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

Univ. of CT Health Center

Farmington, Connecticut, 06030, United States

Location

CNS Healthcare

Jacksonville, Florida, 32216, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Memory Disorder Center

Pompano Beach, Florida, 33064, United States

Location

Neurological Center

Fort Wayne, Indiana, 46805, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66211, United States

Location

Hartford Research Group

Florence, Kentucky, 41042, United States

Location

Lexington Clinic

Lexington, Kentucky, 40504, United States

Location

LSUHSC Geriatric Psychiatry

New Orleans, Louisiana, 70112, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Synergy Medical

Saginaw, Michigan, 48602, United States

Location

University Medical Center, Dept. of Psychiatry Clinical Trials

Jackson, Mississippi, 39216, United States

Location

Radiant Research, Inc.

St Louis, Missouri, 63141, United States

Location

Center For Emotional Fitness

Moorestown, New Jersey, 08057, United States

Location

Ubhc/Umdnj667

Piscataway, New Jersey, 08855, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

The Clinical Trial Center

Jenkintown, Pennsylvania, 19046, United States

Location

Radiant Research

Greer, South Carolina, 29651, United States

Location

Alzheimer's Research & Clinical Programs

North Charleston, South Carolina, 29406, United States

Location

Harmony Research, Inc

Johnson City, Tennessee, 37601, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, 77566, United States

Location

Grayline Clinical Drug Trial

Wichita Falls, Texas, 76309, United States

Location

The Innovative Clinical Research Center

Alexandria, Virginia, 22304, United States

Location

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

Norfolk, Virginia, 23507, United States

Location

National Clinical Research, Inc

Richmond, Virginia, 23294, United States

Location

sanofi-aventis Australia & New Zealand administrative office

Macquarie Park, New South Wales, Australia

Location