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Evaluation of 3APS in Patients With Mild to Moderate Alzheimer’s Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Bellus Health Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Bellus Health Inc
ClinicalTrials.gov Identifier:
NCT00088673
First received: July 30, 2004
Last updated: February 27, 2007
Last verified: February 2007
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Drug: 3APS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Study of the Efficacy and Safety of 3APS in Patients With Mild to Moderate Alzheimer’s Disease

Resource links provided by NLM:


Further study details as provided by Bellus Health Inc:

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.

Estimated Enrollment: 950
Study Start Date: June 2004
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088673

  Hide Study Locations
Locations
United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States
21st Century Neurology, a division of Xenoscience
Phoenix, Arizona, United States
United States, Arkansas
Central Arkansas Research
Hot Springs, Arkansas, United States
United States, California
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
United States, Colorado
Radiant Research
Denver, Colorado, United States
United States, Connecticut
Research Center for Clinical Studies, Inc.
Darien, Connecticut, United States, 06820
Yale University, Alzheimer's Disesase Research Unit
New Haven, Connecticut, United States
New England Research Institute
Stamford, Connecticut, United States
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States
United States, Florida
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
United States, Georgia
Comprehensive Neurology Specialists, PC
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
United States, Illinois
Southern Illinois University (SIU) School of Medicine, Department of Neurology
Springfield, Illinois, United States
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States
United States, Michigan
Mood & Memory Clinic - Dr Aronson
Farmington Hills, Michigan, United States
United States, New Jersey
Memory Enhancement Center
Long Branch, New Jersey, United States
United States, New York
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
United States, North Carolina
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
United States, Ohio
University Memory and Aging Center
Cleveland, Ohio, United States
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, United States
United States, Oklahoma
Clinical Pharmaceuticals Trials, Inc.
Tulsa, Oklahoma, United States
United States, Pennsylvania
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
United States, Rhode Island
CNS Research, Inc.
East Providence, Rhode Island, United States
Memory and Aging Program, Butler Hospital
Providence, Rhode Island, United States
United States, South Carolina
MUSC - Alzheimer's Research and Clinical Programs
North Charleston, South Carolina, United States
United States, Tennessee
Clinical Research Services at Tennessee Christian Medical Center
Madison, Tennessee, United States
United States, Texas
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
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States
Canada, Alberta
Calgary, Alberta, Canada
Canada, British Columbia
The Medical Arts Health Research Group, a Division of PCT Networks, Inc.
Penticton, British Columbia, Canada
Canada, New Brunswick
St. Joseph's Hospital
Saint-John, New Brunswick, Canada
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
Queen's University
Kingston, Ontario, Canada
Geriatric Clinical Trials Group, Parkwood Hospital
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Sunnybrook and Women's College Health Science Centre
Toronto, Ontario, Canada
Gerontion Research
Toronto, Ontario, Canada
Canada, Quebec
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
Centre de recherche Novabyss
Sherbrooke, Quebec, Canada
McGill Centre for Studies in Aging
Verdun (Montreal), Quebec, Canada
Hôpital de l'Enfant-Jésus
Ville de Quebec, Quebec, Canada
Memory & Motor Skills Disorders Clinic
Ville de Québec, Quebec, Canada
Sponsors and Collaborators
Bellus Health Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00088673     History of Changes
Other Study ID Numbers: CL-758007
Study First Received: July 30, 2004
Last Updated: February 27, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Bellus Health Inc:
Alzheimer Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 20, 2014