ELND005 in Patients With Mild to Moderate Alzheimer's Disease
NCT ID: NCT00568776
Last Updated: 2019-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
353 participants
INTERVENTIONAL
2007-12-31
2010-05-31
Brief Summary
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Detailed Description
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This is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral ELND005 in male and female participants aged 50-85 years with mild to moderate AD. Approximately 340 patients will be enrolled into the study at approximately 65 study sites. Patients will be randomized to receive either ELND005 or placebo. Each patient's participation will last approximately 18 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Placebo Control
ELND005 matched placebo capsules for oral administration, bid for 78 weeks
2
ELND005
ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks
3
ELND005
ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks
4
ELND005
ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks
Interventions
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Placebo Control
ELND005 matched placebo capsules for oral administration, bid for 78 weeks
ELND005
ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks
ELND005
ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks
ELND005
ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 50 to 85 years, inclusive
* Mini-Mental Status Exam (MMSE) score of 16-26, inclusive
* Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
* Fluency in English, French, or Spanish
* Stable doses of medications (cholinesterase inhibitors and memantine allowed)
* Caregiver is able to attend all study visits
Exclusion Criteria
* Major psychiatric disorder
* Significant medical illness
* History of stroke or seizure
* History of a heart attack within the last 2 years
* Prior treatment with certain experimental medicines
* Presence of pacemakers or foreign metal objects in the eyes, skin, or body that would prevent patient from having MRI scan
50 Years
85 Years
ALL
No
Sponsors
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OPKO Health, Inc.
INDUSTRY
Responsible Party
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Locations
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Sun Health Research Institute
Sun City, Arizona, United States
University of Arizona, Health Sciences Center, Dept. of Neurology
Tucson, Arizona, United States
Margolin Brain Institute
Fresno, California, United States
Collaborative NeuroScience Network, Inc.
Garden Grove, California, United States
UCLA Alzheimer's Disease Center, Dept. of Neurology
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
UCSF Medical Center, Dept. of Neurology
San Francisco, California, United States
Yale University School of Medicine, Alzheimer's Disease Research Unit
New Haven, Connecticut, United States
Georgetown University Medical Center, Dept. of Neurology
Washington D.C., District of Columbia, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Sunrise Clinical Research, Inc
Hollywood, Florida, United States
Miami Jewish Home and Hospital For The Aged
Miami, Florida, United States
Avision Research Associates, LLC
Miami, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Roskamp Institute
Sarasota, Florida, United States
Neurology Clinical Research, Inc.
Sunrise, Florida, United States
University of South Florida Suncoast Alzheimer's and Gerontology Center
Tampa, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Emory University, Dept. of Neurology
Atlanta, Georgia, United States
Dekalb Neurology Associates, LLC
Decatur, Georgia, United States
Department of Neurology - Indiana University Medical Center
Indianapolis, Indiana, United States
University of Kansas Medical Center, Department of Neurology
Kansas City, Kansas, United States
Innovative Clinical Concepts
Paducah, Kentucky, United States
Brigham and Women's Hospital, Dept. of Neurology
Boston, Massachusetts, United States
University of Michigan, Taubman Health Care Center, Dept. of Neurology
Ann Arbor, Michigan, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
The Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
Global Medical Institutes
Princeton, New Jersey, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, United States
Upstate Clinical Research, LLC
Albany, New York, United States
Neurological Associates of Albany, PC
Albany, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University Sergievsky Center
New York, New York, United States
AD-CARE, Monroe Community Hospital
Rochester, New York, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States
Medford Neurological and Spine Clinic
Medford, Oregon, United States
Summit Research Newtwork, Inc.
Portland, Oregon, United States
Abington Neurological Associates, Inc.
Abington, Pennsylvania, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
University of Pittsburgh Alzheimer Disease Research Clinic
Pittsburgh, Pennsylvania, United States
Butler Hospital, Memory and Aging Center
Providence, Rhode Island, United States
Alliance for Neuro Research, LLC dba Absher Neurology, PA
Greenville, South Carolina, United States
Radiant Research San Antonio
San Antonio, Texas, United States
University of Utah, Dept. of Neurology
Salt Lake City, Utah, United States
Clinical Neuroscience Research Associates, Inc-The Memory Clinic
Bennington, Vermont, United States
University of Vermont Medical Center, Fletcher Allen Health Care, Dept. of Neurology
Burlington, Vermont, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Glenrose Rehabilitation Hospital
Edmonton, Alberta, Canada
University of British Columbia Hospital, Division of Neurology
Vancouver, British Columbia, Canada
Hotel Dieu Hospital
Kingston, Ontario, Canada
Saint Joseph's Health Care London, Saint Joseph's Hospital, Dept. of Cognitive Neurology
London, Ontario, Canada
Parkwood Hospital
London, Ontario, Canada
Sisters of Charity of Ottawa Health Service
Ottawa, Ontario, Canada
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Whitby Mental Health Memory Clinic
Toronto, Ontario, Canada
Gerontion Research, Inc.
Toronto, Ontario, Canada
Neuro-Rive-Sud Memory Clinic
Greenfield Park, Quebec, Canada
Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
Montreal, Quebec, Canada
Countries
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Other Identifiers
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ELND005-AD201
Identifier Type: -
Identifier Source: org_study_id
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