Ginkgo Biloba Prevention Trial in Older Individuals
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| ClinicalTrials.gov Identifier: NCT00010803 |
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Recruitment Status
:
Completed
First Posted
: February 5, 2001
Results First Posted
: September 16, 2010
Last Update Posted
: March 14, 2013
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Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
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 (Responsible Party):
National Center for Complementary and Integrative Health (NCCIH)
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Dementia Alzheimer's Disease | Drug: Ginkgo biloba Drug: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 3069 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | Ginkgo Biloba Prevention Trial in Older Individuals |
| Study Start Date : | October 2000 |
| Actual Primary Completion Date : | April 2008 |
| Actual Study Completion Date : | July 2011 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Dementia
Drug Information available for:
Ginkgo biloba
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo 1 pill twice a day
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Drug: Placebo
One pill twice daily
Other Name: Identical appearance as Ginkgo biloba pill
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Active Comparator: Ginkgo biloba
Ginkgo biloba EGb761 120 mg twice daily
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Drug: Ginkgo biloba
120mg twice a day
Other Name: EGb761
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Primary Outcome Measures
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- Number of Participants With Incident Dementia [ Time Frame: Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up ]All cause dementia based on DSM-IV criteria as determined by an expert panel of clinicians using an adjudication process. A full neuropsychological battery was administered annually, or at 6 month visit if there was a diagnosis of dementia or initiation of medication for dementia by private physician, or change in Modified Mini Mental State Exam (3MSE), Clinical Dementia Rating (CDR), or Alzheimer Disease Assessment Scale (ADAS-Cog). Decline on tests scores based on an algorithm resulted in a neurological exam and brain imaging. These data were used in the adjudication process.
Secondary Outcome Measures
:
- Number of Participants With the Indicated Cardiovascular Disease or Mortality [ Time Frame: 6 months ]Myocardial infarction (MI), angina, stroke (CVA), transient ischemic attack (TIA), combined coronary heart disease (CHD) (MI/angina), combined cerebrovascular (CVA/TIA), peripheral vascular disease, and mortality
- Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance. [ Time Frame: 6 months/annually ]Rate of annual change by cognitive domain in standardized Z-score scale. Higher Z-scores indicate worse performance. Best score = -2.0 Z-score change per year (improvement); worse score = 2.0 Z-score change per year (decline).
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| Ages Eligible for Study: | 75 Years and older (Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Non-demented participants
- Willing to participate in a seven-year follow-up trial of Ginkgo Biloba
- English is their usual language
- Willing informant who has frequent contact with the participant
Exclusion Criteria:
- Currently on anticoagulant therapy
- Cancer diagnosed and treated within the past two years (except for skin cancer)
- Participant with class III - IV congestive heart failure
- Currently being treated with psychopharmacological drugs for depression
- Hospitalized for depression within the last year
- Taking Aricept (or similar agents) for cognitive problems or dementia
- Baseline blood creatinine >2
- Baseline SGGT is a marker of liver function (3 x normal>or=90 IU)
- Baseline hematocrit<30
- Baseline white blood count>or=15,000
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010803
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 | |
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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)
Investigators
| Principal Investigator: | Steven T. DeKosky, M.D. | University of Pittsburgh, Department of Neurology |
Additional Information:
Publications of Results:
Other Publications:
| Responsible Party: | National Center for Complementary and Integrative Health (NCCIH) |
| ClinicalTrials.gov Identifier: | NCT00010803 History of Changes |
| Obsolete Identifiers: | NCT00004535 |
| Other Study ID Numbers: |
U01 AT000162-01M |
| First Posted: | February 5, 2001 Key Record Dates |
| Results First Posted: | September 16, 2010 |
| Last Update Posted: | March 14, 2013 |
| Last Verified: | March 2013 |
Additional relevant MeSH terms:
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |