Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00104013
First received: February 18, 2005
Last updated: August 20, 2008
Last verified: August 2008
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: xaliproden (SR57746A) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
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.
| Enrollment: | 1455 |
| Study Start Date: | November 2003 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104013
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Hide Study LocationsLocations
| United States, Arizona | |
| Pivotal Research Centers | |
| Mesa, Arizona, United States, 85210 | |
| Neurological Physicians of Arizona, Inc. | |
| Mesa, Arizona, United States, 85201 | |
| Pivotal Research Centers | |
| Peoria, Arizona, United States, 85381 | |
| Northwest NeuroSpecialists | |
| Tucson, Arizona, United States, 85741-3537 | |
| United States, California | |
| Optimum Health Services | |
| Oceanside, California, United States, 92056 | |
| Anderson Clinical Research | |
| Redlands, California, United States, 92374 | |
| United States, Connecticut | |
| Univ. of CT Health Center | |
| Farmington, Connecticut, United States, 06030 | |
| United States, Florida | |
| CNS Healthcare | |
| Jacksonville, Florida, United States, 32216 | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| Renstar Medical Research | |
| Ocala, Florida, United States, 34471 | |
| Memory Disorder Center | |
| Pompano Beach, Florida, United States, 33064 | |
| United States, Indiana | |
| Neurological Center | |
| Fort Wayne, Indiana, United States, 46805 | |
| United States, Kansas | |
| Vince and Associates Clinical Research | |
| Overland Park, Kansas, United States, 66211 | |
| United States, Kentucky | |
| Hartford Research Group | |
| Florence, Kentucky, United States, 41042 | |
| Lexington Clinic | |
| Lexington, Kentucky, United States, 40504 | |
| United States, Louisiana | |
| LSUHSC Geriatric Psychiatry | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Synergy Medical | |
| Saginaw, Michigan, United States, 48602 | |
| United States, Mississippi | |
| University Medical Center, Dept. of Psychiatry Clinical Trials | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| Radiant Research, Inc. | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| Center For Emotional Fitness | |
| Moorestown, New Jersey, United States, 08057 | |
| Ubhc/Umdnj667 | |
| Piscataway, New Jersey, United States, 08855 | |
| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| The Clinical Trial Center | |
| Jenkintown, Pennsylvania, United States, 19046 | |
| United States, South Carolina | |
| Radiant Research | |
| Greer, South Carolina, United States, 29651 | |
| Alzheimer's Research & Clinical Programs | |
| North Charleston, South Carolina, United States, 29406 | |
| United States, Tennessee | |
| Harmony Research, Inc | |
| Johnson City, Tennessee, United States, 37601 | |
| United States, Texas | |
| R/D Clinical Research, Inc. | |
| Lake Jackson, Texas, United States, 77566 | |
| Grayline Clinical Drug Trial | |
| Wichita Falls, Texas, United States, 76309 | |
| United States, Virginia | |
| The Innovative Clinical Research Center | |
| Alexandria, Virginia, United States, 22304 | |
| Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology" | |
| Norfolk, Virginia, United States, 23507 | |
| National Clinical Research, Inc | |
| Richmond, Virginia, United States, 23294 | |
| Australia | |
| sanofi-aventis Australia & New Zealand administrative office | |
| Macquarie Park, New South Wales, Australia | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| Hong Kong | |
| Sanofi-Aventis Administrative Office | |
| Causeway Bay, Hong Kong | |
| Italy | |
| Sanfoi-Aventis Administrative Office | |
| Milano, Italy | |
| Netherlands | |
| Sanofi-Aventis Administrative Office | |
| Gouda, Netherlands | |
| Singapore | |
| Sanofi-Aventis Administrative Office | |
| Singapore, Singapore | |
| South Africa | |
| Sanofi-Aventis Administrative Office | |
| Midrand, South Africa | |
| Spain | |
| Sanofi-Aventis Administrative Office | |
| Barcelona, Spain | |
| Taiwan | |
| Sanofi-Aventis Administrative Office | |
| Taipei, Taiwan | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00104013 History of Changes |
| Other Study ID Numbers: | EFC2724, SR57746A |
| Study First Received: | February 18, 2005 |
| Last Updated: | August 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013