Evaluation of 3APS in Patients With Mild to Moderate Alzheimer's Disease
Status unconfirmed · Phase 3
Conditions studied: Alzheimer Disease
In brief
The purpose of this Phase III study is to evaluate the efficacy and safety of 3APS compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.
Key facts
- Study ID
- NCT00088673
- Run by
- Bellus Health Inc. - a GSK company
- People needed
- 950
- Starts
- 2004-06-01
- Last updated by the study team
- 2007-02-28
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients may be included in this study if they meet all of the following criteria:
- Male or Female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
- Diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria).
- Severity of dementia of mild to moderate degree as assessed by the Mini Mental State Examination (MMSE) performed at the screening visit.
- Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
- Potential participant must be treated with conventional Alzheimer's disease therapies and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
- Fluency in English, French or Spanish (oral and written).
- Signed informed consent from potential participant or legal representative and caregiver.
You may not qualify if…
- Patients will not be eligible to participate in the study if they meet any of the following criteria:
- Potential participant with any other cause of dementia.
- Life expectancy less than 2 years.
- Potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease.
- Use of an investigational drug within 30 days prior to the screening visit or during the entire study.
- Previous use of 3APS.
- Patient recruitment is done by participating centers.
Where it is running
- 21st Century Neurology, a division of Xenoscience — Phoenix, Arizona, United States
- Central Arkansas Research — Hot Springs, Arkansas, United States
- Margolin Brain Institute — Fresno, California, United States
- Senior Clinical Trials, Inc. — Laguna Hills, California, United States
- Pacific Research Network, Inc. — San Diego, California, United States
- San Francisco Clinical Research Center — San Francisco, California, United States
- Radiant Research — Denver, Colorado, United States
- Research Center for Clinical Studies, Inc. — Darien, Connecticut, United States
- Yale University, Alzheimer's Disesase Research Unit — New Haven, Connecticut, United States
- New England Research Institute — Stamford, Connecticut, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Neuropsychiatric Research Center of SouthWest Florida — Fort Myers, Florida, United States
- Berma Research Group — Hialeah, Florida, United States
- Tukoi Institute for Clinical Research — Miami, Florida, United States
- Palm Beach Neurological Center — Palm Beach Gardens, Florida, United States
- Quantum Laboratories Inc at the Memory Disorders Clinic, North Broward Medical Center — Pompano Beach, Florida, United States
- Axiom Clinical Research — Tampa, Florida, United States
- Byrd Alzheimer's Center and Research Institute — Tampa, Florida, United States
- Stedman Clinical Trials — Tampa, Florida, United States
- University of South Florida, Suncoast Gerontology Center — Tampa, Florida, United States
- Premiere Research Institute Palm Beach Neurology — West Palm Beach, Florida, United States
- Comprehensive Neurology Specialists, PC — Atlanta, Georgia, United States
- Emory University — Atlanta, Georgia, United States
- Southern Illinois University (SIU) School of Medicine, Department of Neurology — Springfield, Illinois, United States
- Pivotal Research Centers — Peoria, Arizona, United States
Full record on ClinicalTrials.gov
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