Evaluation of 3APS in Patients With Mild to Moderate Alzheimer’s Disease
This trial is active, not recruiting.
|Sponsor||Bellus Health Inc|
|Start date||June 2004|
|Trial size||950 participants|
|Trial identifier||NCT00088673, CL-758007|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Peoria, AZ||Pivotal Research Centers||no longer recruiting|
|Phoenix, AZ||21st Century Neurology, a division of Xenoscience||no longer recruiting|
|Hot Springs, AR||Central Arkansas Research||no longer recruiting|
|Fresno, CA||Margolin Brain Institute||no longer recruiting|
|Laguna Hills, CA||Senior Clinical Trials, Inc.||no longer recruiting|
|San Diego, CA||Pacific Research Network, Inc.||no longer recruiting|
|San Francisco, CA||San Francisco Clinical Research Center||no longer recruiting|
|Denver, CO||Radiant Research||no longer recruiting|
|Darien, CT||Research Center for Clinical Studies, Inc.||no longer recruiting|
|New Haven, CT||Yale University, Alzheimer's Disesase Research Unit||no longer recruiting|
|Stamford, CT||New England Research Institute||no longer recruiting|
|Washington, DC||Georgetown University Medical Center||no longer recruiting|
|Fort Myers, FL||Neuropsychiatric Research Center of SouthWest Florida||no longer recruiting|
|Hialeah, FL||Berma Research Group||no longer recruiting|
|Miami, FL||Tukoi Institute for Clinical Research||no longer recruiting|
|Palm Beach Gardens, FL||Palm Beach Neurological Center||no longer recruiting|
|Pompano Beach, FL||Quantum Laboratories Inc at the Memory Disorders Clinic, North Broward Medical Center||no longer recruiting|
|Tampa, FL||Axiom Clinical Research||no longer recruiting|
|Tampa, FL||Stedman Clinical Trials||no longer recruiting|
|Tampa, FL||Byrd Alzheimer’s Center and Research Institute||no longer recruiting|
|Tampa, FL||University of South Florida, Suncoast Gerontology Center||no longer recruiting|
|West Palm Beach, FL||Premiere Research Institute Palm Beach Neurology||no longer recruiting|
|Atlanta, GA||Emory University||no longer recruiting|
|Atlanta, GA||Comprehensive Neurology Specialists, PC||no longer recruiting|
|Springfield, IL||Southern Illinois University (SIU) School of Medicine, Department of Neurology||no longer recruiting|
|Boston, MA||Brigham & Women's Hospital||no longer recruiting|
|Farmington Hills, MI||Mood & Memory Clinic - Dr Aronson||no longer recruiting|
|Long Branch, NJ||Memory Enhancement Center||no longer recruiting|
|Albany, NY||Neurological Associates of Albany||no longer recruiting|
|New York, NY||Eastside Comprehensive Medical Center||no longer recruiting|
|New York, NY||NYU School of Medicine||no longer recruiting|
|Olean, NY||Global Research and Consulting||no longer recruiting|
|Orangeburg, NY||Nathan S. Kline Institute||no longer recruiting|
|Rochester, NY||University of Rochester-Program in Neurobehavioral Therapeutics||no longer recruiting|
|Raleigh, NC||Richard H. Weisler, MD, PA and Associates||no longer recruiting|
|Winston-Salem, NC||Wake Forest University School of Medicine, Department of Psychiatry and Behavioral Medicine||no longer recruiting|
|Cleveland, OH||University Memory and Aging Center||no longer recruiting|
|Toledo, OH||Neurology and Neuroscience Center of Ohio||no longer recruiting|
|Tulsa, OK||Clinical Pharmaceuticals Trials, Inc.||no longer recruiting|
|Philadelphia, PA||Farber Institute for Neurosciences||no longer recruiting|
|Philadelphia, PA||CNS Research Institute||no longer recruiting|
|Philadelphia, PA||University of Pennsylvania||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh ADRC||no longer recruiting|
|East Providence, RI||CNS Research, Inc.||no longer recruiting|
|Providence, RI||Memory and Aging Program, Butler Hospital||no longer recruiting|
|North Charleston, SC||MUSC - Alzheimer's Research and Clinical Programs||no longer recruiting|
|Madison, TN||Clinical Research Services at Tennessee Christian Medical Center||no longer recruiting|
|Houston, TX||University of Texas Mental Sciences Institute||no longer recruiting|
|San Antonio, TX||Air Force Villages-Freedom House Research (Study open to Air Force Village residents only)||no longer recruiting|
|Bennington, VT||The Memory Clinic||no longer recruiting|
|Calgary, Canada||not available||no longer recruiting|
|Penticton, Canada||The Medical Arts Health Research Group, a Division of PCT Networks, Inc.||no longer recruiting|
|Saint-John, Canada||St. Joseph's Hospital||no longer recruiting|
|Halifax, Canada||Queen Elizabeth II Health Sciences Centre||no longer recruiting|
|Kingston, Canada||Queen's University||no longer recruiting|
|London, Canada||Geriatric Clinical Trials Group, Parkwood Hospital||no longer recruiting|
|Ottawa, Canada||not available||no longer recruiting|
|Toronto, Canada||Toronto Memory Program||no longer recruiting|
|Toronto, Canada||Gerontion Research||no longer recruiting|
|Toronto, Canada||Sunnybrook and Women's College Health Science Centre||no longer recruiting|
|Greenfield Park, Canada||Clinique Neuro Rive-Sud||no longer recruiting|
|Montreal, Canada||Hôpital Maisonneuve-Rosemont, Recherche Clinique de Neurologie||no longer recruiting|
|Montreal, Canada||Jewish General Hospital- Memory Clinic||no longer recruiting|
|Sherbrooke, Canada||Centre de recherche Novabyss||no longer recruiting|
|Verdun (Montreal), Canada||McGill Centre for Studies in Aging||no longer recruiting|
|Ville de Quebec, Canada||Hôpital de l'Enfant-Jésus||no longer recruiting|
|Ville de Québec, Canada||Memory & Motor Skills Disorders Clinic||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
The two primary efficacy parameters are the change from baseline to month 18 in the Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-cog) and the clinical Deterioration Scale Sum of Boxes (CDR-SB) scores.
The brain volume change from baseline as measured by Magnetic Resonance Imaging will also be assessed.
Male or female participants at least 50 years old.
- 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.
- 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.
|Official title||A Phase III Study of the Efficacy and Safety of 3APS in Patients With Mild to Moderate Alzheimer’s Disease|
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