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

Completed · Phase 3

Conditions studied: Alzheimer Disease

In brief

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).

Key facts

Study ID

NCT00103649

Run by

Sanofi

People needed

1306

Starts

2003-11-01

Expected to finish

2007-10-01

Last updated by the study team

2008-08-21

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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 State Examination score of 16 to 26 (inclusive)
• Potential participant may be treated with conventional Alzheimer's disease therapy and must be on 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

Where it is running

• Barrow Neurology Clinics — Phoenix, Arizona, United States
• PsyPharma Clinical Research, Inc. — Phoenix, Arizona, United States
• Radiant Research — Scottsdale, Arizona, United States
• Anaheim Research Center — Anaheim, California, United States
• Margolin Brain Institute — Fresno, California, United States
• Coordinated Clinical Research — La Jolla, California, United States
• Senior Clinical Trials, Inc. — Laguna Hills, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Pharmacology Research Institute — Northridge, California, United States
• Pharmacology Research Institute — Riverside, California, United States
• Pacific Research Network — San Diego, California, United States
• California Neuroscience Research Medical Group — Sherman Oaks, California, United States
• Pacific Research Network — Vista, California, United States
• Radiant Research — Denver, Colorado, United States
• Associated Neurologist — Danbury, Connecticut, United States
• Geriatric and Adult Psychiatry, LLC — Hamden, Connecticut, United States
• Yale University School of Medicine AD Research Unit — New Haven, Connecticut, United States
• Healthcore — Newark, Delaware, United States
• Neurology Associates, PA — Wilmington, Delaware, United States
• Atlantic Institute of Clinical Research — Daytona Beach, Florida, United States
• Berma Research Group — Hialeah, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• Baumel-Eisner Neuromedical Institute in Miami Beach — Miami, Florida, United States
• Baumel-Eisner Neuromedical Institute — Miami, Florida, United States
• UAB Memory Disorders Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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