Evaluation of 3APS in Patients With Mild to Moderate Alzheimer's Disease
A Phase III Study of the Efficacy and Safety of 3APS in Patients With Mild to Moderate Alzheimer's Disease
1 other identifier
interventional
950
2 countries
67
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 alzheimer-disease
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 30, 2004
CompletedFirst Posted
Study publicly available on registry
August 3, 2004
CompletedFebruary 28, 2007
February 1, 2007
July 30, 2004
February 27, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Pivotal Research Centers
Peoria, Arizona, United States
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, 06820, 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
Brigham & Women's Hospital
Boston, Massachusetts, United States
Mood & Memory Clinic - Dr Aronson
Farmington Hills, Michigan, United States
Memory Enhancement Center
Long Branch, New Jersey, United States
Neurological Associates of Albany
Albany, New York, United States
Eastside Comprehensive Medical Center
New York, New York, United States
NYU School of Medicine
New York, New York, United States
Global Research and Consulting
Olean, New York, United States
Nathan S. Kline Institute
Orangeburg, New York, United States
University of Rochester-Program in Neurobehavioral Therapeutics
Rochester, New York, United States
Richard H. Weisler, MD, PA and Associates
Raleigh, North Carolina, United States
Wake Forest University School of Medicine, Department of Psychiatry and Behavioral Medicine
Winston-Salem, North Carolina, United States
University Memory and Aging Center
Cleveland, Ohio, United States
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, United States
Clinical Pharmaceuticals Trials, Inc.
Tulsa, Oklahoma, United States
CNS Research Institute
Philadelphia, Pennsylvania, United States
Farber Institute for Neurosciences
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh ADRC
Pittsburgh, Pennsylvania, United States
CNS Research, Inc.
East Providence, Rhode Island, United States
Memory and Aging Program, Butler Hospital
Providence, Rhode Island, United States
MUSC - Alzheimer's Research and Clinical Programs
North Charleston, South Carolina, United States
Clinical Research Services at Tennessee Christian Medical Center
Madison, Tennessee, United States
University of Texas Mental Sciences Institute
Houston, Texas, United States
Air Force Villages-Freedom House Research (Study open to Air Force Village residents only)
San Antonio, Texas, United States
The Memory Clinic
Bennington, Vermont, United States
Unknown Facility
Calgary, Alberta, Canada
The Medical Arts Health Research Group, a Division of PCT Networks, Inc.
Penticton, British Columbia, Canada
St. Joseph's Hospital
Saint John, New Brunswick, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Queen's University
Kingston, Ontario, Canada
Geriatric Clinical Trials Group, Parkwood Hospital
London, Ontario, Canada
Unknown Facility
Ottawa, Ontario, Canada
Gerontion Research
Toronto, Ontario, Canada
Sunnybrook and Women's College Health Science Centre
Toronto, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada
Hôpital Maisonneuve-Rosemont, Recherche Clinique de Neurologie
Montreal, Quebec, Canada
Jewish General Hospital- Memory Clinic
Montreal, Quebec, Canada
Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada
Memory & Motor Skills Disorders Clinic
Québec, Quebec, Canada
Centre de recherche Novabyss
Sherbrooke, Quebec, Canada
McGill Centre for Studies in Aging
Verdun (Montreal), Quebec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 30, 2004
First Posted
August 3, 2004
Study Start
June 1, 2004
Last Updated
February 28, 2007
Record last verified: 2007-02