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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
xaliproden (SR57746A)
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurological Physicians of Arizona, Inc.
  • Pivotal Research Centers
  • Pivotal Research Centers
  • Northwest NeuroSpecialists
  • Optimum Health Services
  • Anderson Clinical Research
  • Univ. of CT Health Center
  • CNS Healthcare
  • Mayo Clinic
  • Renstar Medical Research
  • Memory Disorder Center
  • Neurological Center
  • Vince and Associates Clinical Research
  • Hartford Research Group
  • Lexington Clinic
  • LSUHSC Geriatric Psychiatry
  • Brigham and Women's Hospital
  • Synergy Medical
  • University Medical Center, Dept. of Psychiatry Clinical Trials
  • Radiant Research, Inc.
  • Center For Emotional Fitness
  • Ubhc/Umdnj667
  • The Ohio State University
  • The Clinical Trial Center
  • Radiant Research
  • Alzheimer's Research & Clinical Programs
  • Harmony Research, Inc
  • R/D Clinical Research, Inc.
  • Grayline Clinical Drug Trial
  • The Innovative Clinical Research Center
  • Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology"
  • National Clinical Research, Inc
  • sanofi-aventis Australia & New Zealand administrative office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanfoi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2005
Last Updated
August 20, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00104013
Brief Title
Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1455 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
xaliproden (SR57746A)
Primary Outcome Measure Information:
Title
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
Secondary Outcome Measure Information:
Title
Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Neurological Physicians of Arizona, Inc.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85201
Country
United States
Facility Name
Pivotal Research Centers
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Pivotal Research Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Northwest NeuroSpecialists
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741-3537
Country
United States
Facility Name
Optimum Health Services
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Univ. of CT Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
CNS Healthcare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Memory Disorder Center
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Hartford Research Group
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
Lexington Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
LSUHSC Geriatric Psychiatry
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Synergy Medical
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
University Medical Center, Dept. of Psychiatry Clinical Trials
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Radiant Research, Inc.
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Center For Emotional Fitness
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Ubhc/Umdnj667
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08855
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Clinical Trial Center
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Radiant Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Alzheimer's Research & Clinical Programs
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Harmony Research, Inc
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Grayline Clinical Drug Trial
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
The Innovative Clinical Research Center
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology"
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
National Clinical Research, Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
sanofi-aventis Australia & New Zealand administrative office
City
Macquarie Park, New South Wales
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Causeway Bay
Country
Hong Kong
Facility Name
Sanfoi-Aventis Administrative Office
City
Milano
Country
Italy
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Singapore
Country
Singapore
Facility Name
Sanofi-Aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
http://www.sanofi-aventis.com
Description
Related Info

Learn more about this trial

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

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