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

NCT ID: NCT00088673

Last Updated: 2007-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

950 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Keywords

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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3APS

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bellus Health Inc. - a GSK company

INDUSTRY

Sponsor Role lead

Locations

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Pivotal Research Centers

Peoria, Arizona, United States

Site Status

21st Century Neurology, a division of Xenoscience

Phoenix, Arizona, United States

Site Status

Central Arkansas Research

Hot Springs, Arkansas, United States

Site Status

Margolin Brain Institute

Fresno, California, United States

Site Status

Senior Clinical Trials, Inc.

Laguna Hills, California, United States

Site Status

Pacific Research Network, Inc.

San Diego, California, United States

Site Status

San Francisco Clinical Research Center

San Francisco, California, United States

Site Status

Radiant Research

Denver, Colorado, United States

Site Status

Research Center for Clinical Studies, Inc.

Darien, Connecticut, United States

Site Status

Yale University, Alzheimer's Disesase Research Unit

New Haven, Connecticut, United States

Site Status

New England Research Institute

Stamford, Connecticut, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Neuropsychiatric Research Center of SouthWest Florida

Fort Myers, Florida, United States

Site Status

Berma Research Group

Hialeah, Florida, United States

Site Status

Tukoi Institute for Clinical Research

Miami, Florida, United States

Site Status

Palm Beach Neurological Center

Palm Beach Gardens, Florida, United States

Site Status

Quantum Laboratories Inc at the Memory Disorders Clinic, North Broward Medical Center

Pompano Beach, Florida, United States

Site Status

Axiom Clinical Research

Tampa, Florida, United States

Site Status

Byrd Alzheimer's Center and Research Institute

Tampa, Florida, United States

Site Status

Stedman Clinical Trials

Tampa, Florida, United States

Site Status

University of South Florida, Suncoast Gerontology Center

Tampa, Florida, United States

Site Status

Premiere Research Institute Palm Beach Neurology

West Palm Beach, Florida, United States

Site Status

Comprehensive Neurology Specialists, PC

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Southern Illinois University (SIU) School of Medicine, Department of Neurology

Springfield, Illinois, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Mood & Memory Clinic - Dr Aronson

Farmington Hills, Michigan, United States

Site Status

Memory Enhancement Center

Long Branch, New Jersey, United States

Site Status

Neurological Associates of Albany

Albany, New York, United States

Site Status

Eastside Comprehensive Medical Center

New York, New York, United States

Site Status

NYU School of Medicine

New York, New York, United States

Site Status

Global Research and Consulting

Olean, New York, United States

Site Status

Nathan S. Kline Institute

Orangeburg, New York, United States

Site Status

University of Rochester-Program in Neurobehavioral Therapeutics

Rochester, New York, United States

Site Status

Richard H. Weisler, MD, PA and Associates

Raleigh, North Carolina, United States

Site Status

Wake Forest University School of Medicine, Department of Psychiatry and Behavioral Medicine

Winston-Salem, North Carolina, United States

Site Status

University Memory and Aging Center

Cleveland, Ohio, United States

Site Status

Neurology and Neuroscience Center of Ohio

Toledo, Ohio, United States

Site Status

Clinical Pharmaceuticals Trials, Inc.

Tulsa, Oklahoma, United States

Site Status

CNS Research Institute

Philadelphia, Pennsylvania, United States

Site Status

Farber Institute for Neurosciences

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh ADRC

Pittsburgh, Pennsylvania, United States

Site Status

CNS Research, Inc.

East Providence, Rhode Island, United States

Site Status

Memory and Aging Program, Butler Hospital

Providence, Rhode Island, United States

Site Status

MUSC - Alzheimer's Research and Clinical Programs

North Charleston, South Carolina, United States

Site Status

Clinical Research Services at Tennessee Christian Medical Center

Madison, Tennessee, United States

Site Status

University of Texas Mental Sciences Institute

Houston, Texas, United States

Site Status

Air Force Villages-Freedom House Research (Study open to Air Force Village residents only)

San Antonio, Texas, United States

Site Status

The Memory Clinic

Bennington, Vermont, United States

Site Status

Calgary, Alberta, Canada

Site Status

The Medical Arts Health Research Group, a Division of PCT Networks, Inc.

Penticton, British Columbia, Canada

Site Status

St. Joseph's Hospital

Saint John, New Brunswick, Canada

Site Status

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Queen's University

Kingston, Ontario, Canada

Site Status

Geriatric Clinical Trials Group, Parkwood Hospital

London, Ontario, Canada

Site Status

Ottawa, Ontario, Canada

Site Status

Gerontion Research

Toronto, Ontario, Canada

Site Status

Sunnybrook and Women's College Health Science Centre

Toronto, Ontario, Canada

Site Status

Toronto Memory Program

Toronto, Ontario, Canada

Site Status

Clinique Neuro Rive-Sud

Greenfield Park, Quebec, Canada

Site Status

Hôpital Maisonneuve-Rosemont, Recherche Clinique de Neurologie

Montreal, Quebec, Canada

Site Status

Jewish General Hospital- Memory Clinic

Montreal, Quebec, Canada

Site Status

Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

Site Status

Memory & Motor Skills Disorders Clinic

Québec, Quebec, Canada

Site Status

Centre de recherche Novabyss

Sherbrooke, Quebec, Canada

Site Status

McGill Centre for Studies in Aging

Verdun (Montreal), Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CL-758007

Identifier Type: -

Identifier Source: org_study_id