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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104013
• Other study ID #: EFC2724
• Secondary ID: SR57746A
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2005
• Last updated: August 20, 2008
• Start date: November 2003
• Est. completion date: November 2007

Study information

• Verified date: August 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1455
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• xaliproden (SR57746A)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
Secondary	Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.

External Links

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