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

Alzheimer Disease Clinical Trial

Official title:

A Phase III Study of the Efficacy and Safety of 3APS in Patients With Mild to Moderate Alzheimer’s Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00088673
• Other study ID #: CL-758007
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 30, 2004
• Last updated: February 27, 2007
• Start date: June 2004

Study information

• Verified date: February 2007
• Source: Bellus Health Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 950
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• 3APS

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bellus Health Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	The brain volume change from baseline as measured by Magnetic Resonance Imaging will also be assessed.