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Ginkgo Biloba Prevention Trial in Older Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00010803
Recruitment Status : Completed
First Posted : February 5, 2001
Results First Posted : September 16, 2010
Last Update Posted : March 14, 2013
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)

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

Detailed Description:
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.

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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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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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)
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Principal Investigator: Steven T. DeKosky, M.D. University of Pittsburgh, Department of Neurology
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier: NCT00010803    
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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders