Back to resultsEvaluation of 3APS in Patients With Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
3APS
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer Disease
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Pivotal Research Centers
- 21st Century Neurology, a division of Xenoscience
- Central Arkansas Research
- Margolin Brain Institute
- Senior Clinical Trials, Inc.
- Pacific Research Network, Inc.
- San Francisco Clinical Research Center
- Radiant Research
- Research Center for Clinical Studies, Inc.
- Yale University, Alzheimer's Disesase Research Unit
- New England Research Institute
- Georgetown University Medical Center
- Neuropsychiatric Research Center of SouthWest Florida
- Berma Research Group
- Tukoi Institute for Clinical Research
- Palm Beach Neurological Center
- Quantum Laboratories Inc at the Memory Disorders Clinic, North Broward Medical Center
- Axiom Clinical Research
- Byrd Alzheimer's Center and Research Institute
- Stedman Clinical Trials
- University of South Florida, Suncoast Gerontology Center
- Premiere Research Institute Palm Beach Neurology
- Comprehensive Neurology Specialists, PC
- Emory University
- Southern Illinois University (SIU) School of Medicine, Department of Neurology
- Brigham & Women's Hospital
- Mood & Memory Clinic - Dr Aronson
- Memory Enhancement Center
- Neurological Associates of Albany
- Eastside Comprehensive Medical Center
- NYU School of Medicine
- Global Research and Consulting
- Nathan S. Kline Institute
- University of Rochester-Program in Neurobehavioral Therapeutics
- Richard H. Weisler, MD, PA and Associates
- Wake Forest University School of Medicine, Department of Psychiatry and Behavioral Medicine
- University Memory and Aging Center
- Neurology and Neuroscience Center of Ohio
- Clinical Pharmaceuticals Trials, Inc.
- CNS Research Institute
- Farber Institute for Neurosciences
- University of Pennsylvania
- University of Pittsburgh ADRC
- CNS Research, Inc.
- Memory and Aging Program, Butler Hospital
- MUSC - Alzheimer's Research and Clinical Programs
- Clinical Research Services at Tennessee Christian Medical Center
- University of Texas Mental Sciences Institute
- Air Force Villages-Freedom House Research (Study open to Air Force Village residents only)
- The Memory Clinic
- The Medical Arts Health Research Group, a Division of PCT Networks, Inc.
- St. Joseph's Hospital
- Queen Elizabeth II Health Sciences Centre
- Queen's University
- Geriatric Clinical Trials Group, Parkwood Hospital
- Gerontion Research
- Sunnybrook and Women's College Health Science Centre
- Toronto Memory Program
- Clinique Neuro Rive-Sud
- Hôpital Maisonneuve-Rosemont, Recherche Clinique de Neurologie
- Jewish General Hospital- Memory Clinic
- Centre de recherche Novabyss
- McGill Centre for Studies in Aging
- Hôpital de l'Enfant-Jésus
- Memory & Motor Skills Disorders Clinic
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00088673
Brief Title
Evaluation of 3APS in Patients With Mild to Moderate Alzheimer's Disease
Official Title
A Phase III Study of the Efficacy and Safety of 3APS in Patients With Mild to Moderate Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bellus Health Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
950 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
3APS
Primary Outcome Measure Information:
Title
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.
Title
The brain volume change from baseline as measured by Magnetic Resonance Imaging will also be assessed.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Pivotal Research Centers
City
Peoria
State/Province
Arizona
Country
United States
Facility Name
21st Century Neurology, a division of Xenoscience
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Central Arkansas Research
City
Hot Springs
State/Province
Arkansas
Country
United States
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
Country
United States
Facility Name
Senior Clinical Trials, Inc.
City
Laguna Hills
State/Province
California
Country
United States
Facility Name
Pacific Research Network, Inc.
City
San Diego
State/Province
California
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
Country
United States
Facility Name
Radiant Research
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Research Center for Clinical Studies, Inc.
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
Yale University, Alzheimer's Disesase Research Unit
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
New England Research Institute
City
Stamford
State/Province
Connecticut
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Neuropsychiatric Research Center of SouthWest Florida
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Berma Research Group
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Tukoi Institute for Clinical Research
City
Miami
State/Province
Florida
Country
United States
Facility Name
Palm Beach Neurological Center
City
Palm Beach Gardens
State/Province
Florida
Country
United States
Facility Name
Quantum Laboratories Inc at the Memory Disorders Clinic, North Broward Medical Center
City
Pompano Beach
State/Province
Florida
Country
United States
Facility Name
Axiom Clinical Research
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Byrd Alzheimer's Center and Research Institute
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
Country
United States
Facility Name
University of South Florida, Suncoast Gerontology Center
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Premiere Research Institute Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Comprehensive Neurology Specialists, PC
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Southern Illinois University (SIU) School of Medicine, Department of Neurology
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Mood & Memory Clinic - Dr Aronson
City
Farmington Hills
State/Province
Michigan
Country
United States
Facility Name
Memory Enhancement Center
City
Long Branch
State/Province
New Jersey
Country
United States
Facility Name
Neurological Associates of Albany
City
Albany
State/Province
New York
Country
United States
Facility Name
Eastside Comprehensive Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
Country
United States
Facility Name
Global Research and Consulting
City
Olean
State/Province
New York
Country
United States
Facility Name
Nathan S. Kline Institute
City
Orangeburg
State/Province
New York
Country
United States
Facility Name
University of Rochester-Program in Neurobehavioral Therapeutics
City
Rochester
State/Province
New York
Country
United States
Facility Name
Richard H. Weisler, MD, PA and Associates
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Wake Forest University School of Medicine, Department of Psychiatry and Behavioral Medicine
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
University Memory and Aging Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Neurology and Neuroscience Center of Ohio
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Clinical Pharmaceuticals Trials, Inc.
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
CNS Research Institute
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Farber Institute for Neurosciences
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh ADRC
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
CNS Research, Inc.
City
East Providence
State/Province
Rhode Island
Country
United States
Facility Name
Memory and Aging Program, Butler Hospital
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
MUSC - Alzheimer's Research and Clinical Programs
City
North Charleston
State/Province
South Carolina
Country
United States
Facility Name
Clinical Research Services at Tennessee Christian Medical Center
City
Madison
State/Province
Tennessee
Country
United States
Facility Name
University of Texas Mental Sciences Institute
City
Houston
State/Province
Texas
Country
United States
Facility Name
Air Force Villages-Freedom House Research (Study open to Air Force Village residents only)
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
The Memory Clinic
City
Bennington
State/Province
Vermont
Country
United States
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
The Medical Arts Health Research Group, a Division of PCT Networks, Inc.
City
Penticton
State/Province
British Columbia
Country
Canada
Facility Name
St. Joseph's Hospital
City
Saint-John
State/Province
New Brunswick
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Geriatric Clinical Trials Group, Parkwood Hospital
City
London
State/Province
Ontario
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Gerontion Research
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook and Women's College Health Science Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto Memory Program
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Clinique Neuro Rive-Sud
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont, Recherche Clinique de Neurologie
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Jewish General Hospital- Memory Clinic
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre de recherche Novabyss
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
McGill Centre for Studies in Aging
City
Verdun (Montreal)
State/Province
Quebec
Country
Canada
Facility Name
Hôpital de l'Enfant-Jésus
City
Ville de Quebec
State/Province
Quebec
Country
Canada
Facility Name
Memory & Motor Skills Disorders Clinic
City
Ville de Québec
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Evaluation of 3APS in Patients With Mild to Moderate Alzheimer's Disease
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