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| Sponsor: | Elan Pharmaceuticals |
|---|---|
| Collaborator: |
Transition Therapeutics |
| Information provided by: | Elan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00568776 |
Purpose
The purpose of this study is to evaluate the dose-related safety and efficacy of multiple oral dosages of ELND005 as treatment for Alzheimer's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: ELND005 Drug: Placebo Control |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease |
| Estimated Enrollment: | 340 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator | Drug: ELND005 |
| 2: Active Comparator | Drug: ELND005 |
| 3: Active Comparator | Drug: ELND005 |
| 4: Placebo Comparator | Drug: Placebo Control |
ELND005 (formerly known as AZD-103), scyllo-inositol, is being investigated as an orally administered treatment for Alzheimer's disease (AD). ELND005 may prevent or inhibit the build up of amyloid protein in the brains of Alzheimer's disease patients.
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.
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| University of Arizona, Health Sciences Center, Dept. of Neurology | |
| Tucson, Arizona, United States, 85724 | |
| Sun Health Research Institute | |
| Sun City, Arizona, United States, 85351 | |
| Banner Alzheimer's Institute | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| UCLA Alzheimer's Disease Center, Dept. of Neurology | |
| Los Angeles, California, United States, 90095 | |
| UC Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Margolin Brain Institute | |
| Fresno, California, United States, 93720 | |
| Collaborative NeuroScience Network, Inc. | |
| Garden Grove, California, United States, 92845 | |
| UCSF Medical Center, Dept. of Neurology | |
| San Francisco, California, United States, 94143 | |
| United States, Connecticut | |
| Yale University School of Medicine, Alzheimer's Disease Research Unit | |
| New Haven, Connecticut, United States, 06510 | |
| United States, District of Columbia | |
| Georgetown University Medical Center, Dept. of Neurology | |
| Washington, District of Columbia, United States, 20057 | |
| United States, Florida | |
| Brain Matters Research, Inc. | |
| Delray Beach, Florida, United States, 33445 | |
| Miami Jewish Home and Hospital For The Aged | |
| Miami, Florida, United States, 33137 | |
| Premiere Research Institute | |
| West Palm Beach, Florida, United States, 33407 | |
| Avision Research Associates, LLC | |
| Miami, Florida, United States, 33173 | |
| Roskamp Institute | |
| Sarasota, Florida, United States, 34243 | |
| Compass Research, LLC | |
| Orlando, Florida, United States, 32806 | |
| Neurology Clinical Research, Inc. | |
| Sunrise, Florida, United States, 33351 | |
| Sunrise Clinical Research, Inc | |
| Hollywood, Florida, United States, 33021 | |
| University of South Florida Suncoast Alzheimer's and Gerontology Center | |
| Tampa, Florida, United States, 33617 | |
| United States, Georgia | |
| Dekalb Neurology Associates, LLC | |
| Decatur, Georgia, United States, 30033 | |
| Emory University, Dept. of Neurology | |
| Atlanta, Georgia, United States, 30329 | |
| United States, Indiana | |
| Department of Neurology - Indiana University Medical Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| University of Kansas Medical Center, Department of Neurology | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| Innovative Clinical Concepts | |
| Paducah, Kentucky, United States, 42003 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital, Dept. of Neurology | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan, Taubman Health Care Center, Dept. of Neurology | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Nevada | |
| University of Nevada School of Medicine | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| The Memory Enhancement Center of America, Inc. | |
| Eatontown, New Jersey, United States, 07724 | |
| Global Medical Institutes | |
| Princeton, New Jersey, United States, 08540 | |
| Comprehensive Clinical Research | |
| Berlin, New Jersey, United States, 08009 | |
| United States, New Mexico | |
| Albuquerque Neuroscience, Inc. | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| Neurological Associates of Albany, PC | |
| Albany, New York, United States, 12208 | |
| AD-CARE, Monroe Community Hospital | |
| Rochester, New York, United States, 14620 | |
| Columbia University Sergievsky Center | |
| New York, New York, United States, 10032 | |
| Upstate Clinical Research, LLC | |
| Albany, New York, United States, 12205 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Raleigh Neurology Associates | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Ohio | |
| Neurology & Neuroscience Center of Ohio | |
| Toledo, Ohio, United States, 43623 | |
| United States, Oregon | |
| Summit Research Newtwork, Inc. | |
| Portland, Oregon, United States, 97210 | |
| Medford Neurological and Spine Clinic | |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| The Clinical Trial Center, LLC | |
| Jenkintown, Pennsylvania, United States, 19046 | |
| University of Pittsburgh Alzheimer Disease Research Clinic | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Abington Neurological Associates, Inc. | |
| Abington, Pennsylvania, United States, 19001 | |
| United States, Rhode Island | |
| Butler Hospital, Memory and Aging Center | |
| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| Alliance for Neuro Research, LLC dba Absher Neurology, PA | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Texas | |
| Radiant Research San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| University of Utah, Dept. of Neurology | |
| Salt Lake City, Utah, United States, 84108 | |
| United States, Vermont | |
| Clinical Neuroscience Research Associates, Inc-The Memory Clinic | |
| Bennington, Vermont, United States, 05201 | |
| University of Vermont Medical Center, Fletcher Allen Health Care, Dept. of Neurology | |
| Burlington, Vermont, United States, 05405 | |
| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22903 | |
| Canada, Alberta | |
| Glenrose Rehabilitation Hospital | |
| Edmonton, Alberta, Canada, T5G 0B7 | |
| Canada, British Columbia | |
| University of British Columbia Hospital, Division of Neurology | |
| Vancouver, British Columbia, Canada, V6T 2B5 | |
| Canada, Ontario | |
| Parkwood Hospital | |
| London, Ontario, Canada, N6C 5J1 | |
| Sisters of Charity of Ottawa Health Service | |
| Ottawa, Ontario, Canada, K1N 5C8 | |
| Whitby Mental Health Memory Clinic | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Toronto Memory Program | |
| Toronto, Ontario, Canada, M3B 2S7 | |
| Hotel Dieu Hospital | |
| Kingston, Ontario, Canada, K7L 5G2 | |
| Kawartha Regional Memory Clinic | |
| Peterborough, Ontario, Canada, K9H 2P4 | |
| Saint Joseph's Health Care London, Saint Joseph's Hospital, Dept. of Cognitive Neurology | |
| London, Ontario, Canada, N6A 4V2 | |
| Gerontion Research, Inc. | |
| Toronto, Ontario, Canada, M6M 3Z5 | |
| Canada, Quebec | |
| Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont) | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Neuro-Rive-Sud Memory Clinic | |
| Greenfield Park, Quebec, Canada, J4V 2J2 | |
More Information
| Responsible Party: | Elan Pharmaceuticals ( VP Clinical Development ) |
| Study ID Numbers: | ELND005-AD201 |
| Study First Received: | December 4, 2007 |
| Last Updated: | July 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00568776 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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