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| Sponsor: | National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Collaborators: |
Office of Dietary Supplements (ODS) National Institute of Neurological Disorders and Stroke (NINDS) National Institute on Aging (NIA) National Heart, Lung, and Blood Institute (NHLBI) |
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00010803 |
Purpose
This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence of dementia and specifically Alzheimer's disease (AD), slowing cognitive decline and functional disability, reducing incidence of cardiovascular disease, and decreasing total mortality.
| Condition | Intervention | Phase |
|---|---|---|
|
Dementia Alzheimer's Disease |
Drug: Ginkgo biloba Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Ginkgo Biloba Prevention Trial in Older Individuals |
| Enrollment: | 3069 |
| Study Start Date: | October 2000 |
| Estimated Study Completion Date: | July 2011 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo 1 pill twice a day
|
Drug: Placebo
One pill twice daily
Other Name: Identical appearance as Ginkgo biloba pill
|
|
Active Comparator: Ginkgo biloba
Ginkgo biloba EGb761 120 mg twice daily
|
Drug: Ginkgo biloba
120mg twice a day
Other Name: EGb761
|
Participants will be studied in a randomized trial of 240 mg of Ginkgo biloba as compared to placebo in healthy men and women, at least 75 years old. The trial will last approximately 8 years. The intervention will be considered unsuccessful in those participants who succumb to dementia, including Alzheimer's Disease and vascular dementia. There are four clinical centers: Pittsburgh, PA; Hagerstown, MD; Winston-Salem, NC; and Sacramento, CA; and a Coordinating Center at the University of Washington, Seattle. There will be a clinic visit every 6 months to determine morbidity, mortality and change in cognition that will include repeat of ADAS, CDR, and 10 battery neuropsychological evaluation and informant interview. The primary endpoint is dementia, specifically Alzheimer's disease, secondary endpoint will include the incidence of vascular disease, changes in cognitive function scores over time, total mortality and changes in functional status. The diagnosis of dementia will be based on neuropsychological testing, neurological exam, MRI, functional measurements, and review by a central adjudication committee and classified by DSM IV, NINCDS criteria and ADRTC criteria for vascular disease.
Eligibility| Ages Eligible for Study: | 75 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California, Davis | |
| Sacramento, California, United States, 95817 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| United States, North Carolina | |
| Wake Forest University School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157-1063 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Virginia | |
| University of Pittsburgh/University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Principal Investigator: | Steven T. DeKosky, M.D. | University of Pittsburgh, Department of Neurology |
More Information
| Responsible Party: | Steven T. DeKosky MD, University of Pittsburgh/University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00010803 History of Changes |
| Obsolete Identifiers: | NCT00004535 |
| Other Study ID Numbers: | U01 AT000162-01M |
| Study First Received: | February 2, 2001 |
| Results First Received: | March 27, 2009 |
| Last Updated: | November 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |