Clinical trial NCT00088673: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
Lead sponsor: Bellus Health Inc. - a GSK company
Sponsor class: INDUSTRY
First posted: 2004-08-03
Enrollment: 950
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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