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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3APS | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Patients may be included in this study if they meet all of the following criteria:
Exclusion Criteria:
Patients will not be eligible to participate in the study if they meet any of the following criteria:
Patient recruitment is done by participating centers.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pivotal Research Centers | Peoria | Arizona | United States | |||
| 21st Century Neurology, a division of Xenoscience |
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| Phoenix |
| Arizona |
| United States |
| Central Arkansas Research | Hot Springs | Arkansas | United States |
| 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 |
| Radiant Research | Denver | Colorado | United States |
| Research Center for Clinical Studies, Inc. | Darien | Connecticut | 06820 | United States |
| Yale University, Alzheimer's Disesase Research Unit | New Haven | Connecticut | United States |
| New England Research Institute | Stamford | Connecticut | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | United States |
| 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 |
| Comprehensive Neurology Specialists, PC | Atlanta | Georgia | United States |
| Emory University | Atlanta | Georgia | United States |
| Southern Illinois University (SIU) School of Medicine, Department of Neurology | Springfield | Illinois | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | United States |
| Mood & Memory Clinic - Dr Aronson | Farmington Hills | Michigan | United States |
| Memory Enhancement Center | Long Branch | New Jersey | United States |
| 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 |
| 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 |
| University Memory and Aging Center | Cleveland | Ohio | United States |
| Neurology and Neuroscience Center of Ohio | Toledo | Ohio | United States |
| Clinical Pharmaceuticals Trials, Inc. | Tulsa | Oklahoma | United States |
| 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 |
| CNS Research, Inc. | East Providence | Rhode Island | United States |
| Memory and Aging Program, Butler Hospital | Providence | Rhode Island | United States |
| MUSC - Alzheimer's Research and Clinical Programs | North Charleston | South Carolina | United States |
| Clinical Research Services at Tennessee Christian Medical Center | Madison | Tennessee | United States |
| 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 |
| The Memory Clinic | Bennington | Vermont | United States |
| Calgary | Alberta | 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 |
| 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 |
| Ottawa | Ontario | Canada |
| Gerontion Research | Toronto | Ontario | Canada |
| Sunnybrook and Women's College Health Science Centre | Toronto | Ontario | Canada |
| Toronto Memory Program | Toronto | Ontario | Canada |
| 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 |
| Hôpital de l'Enfant-Jésus | Québec | Quebec | Canada |
| Memory & Motor Skills Disorders Clinic | Québec | Quebec | Canada |
| Centre de recherche Novabyss | Sherbrooke | Quebec | Canada |
| McGill Centre for Studies in Aging | Verdun (Montreal) | Quebec | Canada |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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