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

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.

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: 3APS

• Study Type: Interventional
• Enrollment: 950
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
  • British Columbia
    • Penticton, British Columbia, Canada
      • The Medical Arts Health Research Group, a Division of PCT Networks, Inc.
  • New Brunswick
    • Saint-John, New Brunswick, Canada
      • St. Joseph's Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Kingston, Ontario, Canada
      • Queen's University
    • London, Ontario, Canada
      • Geriatric Clinical Trials Group, Parkwood Hospital
    • Ottawa, Ontario, Canada
    • Toronto, Ontario, Canada
      • Toronto Memory Program
    • Toronto, Ontario, Canada
      • Gerontion Research
    • Toronto, Ontario, Canada
      • Sunnybrook and Women's College Health Science Centre
  • Quebec
    • Greenfield Park, Quebec, Canada
      • Clinique Neuro Rive-Sud
    • Montreal, Quebec, Canada
      • Hôpital Maisonneuve-Rosemont, Recherche Clinique de Neurologie
    • Montreal, Quebec, Canada
      • Jewish General Hospital- Memory Clinic
    • Sherbrooke, Quebec, Canada
      • Centre de recherche Novabyss
    • Verdun (Montreal), Quebec, Canada
      • McGill Centre for Studies in Aging
    • Ville de Quebec, Quebec, Canada
      • Hôpital de L'Enfant-Jésus
    • Ville de Québec, Quebec, Canada
      • Memory & Motor Skills Disorders Clinic
• United States
  • Arizona
    • Peoria, Arizona, United States
      • Pivotal Research Centers
    • Phoenix, Arizona, United States
      • 21st Century Neurology, a division of Xenoscience
  • Arkansas
    • Hot Springs, Arkansas, United States
      • Central Arkansas Research
  • California
    • Fresno, California, United States
      • Margolin Brain Institute
    • Laguna Hills, California, United States
      • Senior Clinical Trials, Inc.
    • San Diego, California, United States
      • Pacific Research Network, Inc.
    • San Francisco, California, United States
      • San Francisco Clinical Research Center
  • Colorado
    • Denver, Colorado, United States
      • Radiant Research
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • Research Center for Clinical Studies, Inc.
    • New Haven, Connecticut, United States
      • Yale University, Alzheimer's Disesase Research Unit
    • Stamford, Connecticut, United States
      • New England Research Institute
  • District of Columbia
    • Washington, District of Columbia, United States
      • Georgetown University Medical Center
  • Florida
    • Fort Myers, Florida, United States
      • Neuropsychiatric Research Center of Southwest Florida
    • Hialeah, Florida, United States
      • Berma Research Group
    • Miami, Florida, United States
      • Tukoi Institute for Clinical Research
    • Palm Beach Gardens, Florida, United States
      • Palm Beach Neurological Center
    • Pompano Beach, Florida, United States
      • Quantum Laboratories Inc at the Memory Disorders Clinic, North Broward Medical Center
    • Tampa, 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
    • West Palm Beach, Florida, United States
      • Premiere Research Institute Palm Beach Neurology
  • Georgia
    • Atlanta, Georgia, United States
      • Emory University
    • Atlanta, Georgia, United States
      • Comprehensive Neurology Specialists, PC
  • Illinois
    • Springfield, Illinois, United States
      • Southern Illinois University (SIU) School of Medicine, Department of Neurology
  • Massachusetts
    • Boston, Massachusetts, United States
      • Brigham & Women's Hospital
  • Michigan
    • Farmington Hills, Michigan, United States
      • Mood & Memory Clinic - Dr Aronson
  • New Jersey
    • Long Branch, New Jersey, United States
      • Memory Enhancement Center
  • New York
    • Albany, New York, United States
      • Neurological Associates of Albany
    • New York, New York, United States
      • NYU School of Medicine
    • New York, New York, United States
      • Eastside Comprehensive Medical Center
    • Olean, New York, United States
      • Global Research and Consulting
    • Orangeburg, New York, United States
      • Nathan S. Kline Institute
    • Rochester, New York, United States
      • University of Rochester-Program in Neurobehavioral Therapeutics
  • North Carolina
    • Raleigh, North Carolina, United States
      • Richard H. Weisler, MD, PA and Associates
    • Winston-Salem, North Carolina, United States
      • Wake Forest University School of Medicine, Department of Psychiatry and Behavioral Medicine
  • Ohio
    • Cleveland, Ohio, United States
      • University Memory and Aging Center
    • Toledo, Ohio, United States
      • Neurology and Neuroscience Center of Ohio
  • Oklahoma
    • Tulsa, Oklahoma, United States
      • Clinical Pharmaceuticals Trials, Inc.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • CNS Research Institute
    • Philadelphia, Pennsylvania, United States
      • Farber Institute for Neurosciences
    • Pittsburgh, Pennsylvania, United States
      • University of Pittsburgh ADRC
  • Rhode Island
    • East Providence, Rhode Island, United States
      • CNS Research, Inc.
    • Providence, Rhode Island, United States
      • Memory and Aging Program, Butler Hospital
  • South Carolina
    • North Charleston, South Carolina, United States
      • MUSC - Alzheimer's Research and Clinical Programs
  • Tennessee
    • Madison, Tennessee, United States
      • Clinical Research Services at Tennessee Christian Medical Center
  • Texas
    • Houston, Texas, United States
      • University of Texas Mental Sciences Institute
    • San Antonio, Texas, United States
      • Air Force Villages-Freedom House Research (Study open to Air Force Village residents only)
  • Vermont
    • Bennington, Vermont, United States
      • The Memory Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Bellus Health Inc

Study record dates

Study Major Dates

• Study Start: June 1, 2004

Study Registration Dates

• First Submitted: July 30, 2004
• First Submitted That Met QC Criteria: August 2, 2004
• First Posted (Estimate): August 3, 2004

Study Record Updates

• Last Update Posted (Estimate): February 28, 2007
• Last Update Submitted That Met QC Criteria: February 27, 2007
• Last Verified: February 1, 2007

More Information

Terms related to this study

• Keywords: Alzheimer Disease
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: CL-758007