Ginkgo Biloba Prevention Trial in Older Individuals

March 11, 2013 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3069

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1063
        • Wake Forest University School of Medicine
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Pittsburgh/University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo 1 pill twice a day
Drug: Placebo
One pill twice daily
Other Names:
  • 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 Names:
  • EGb761

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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).
6 months/annually

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
Office of Dietary Supplements (ODS)

Investigators

  • Principal Investigator: Steven T. DeKosky, M.D., University of Pittsburgh, Department of Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

February 2, 2001

First Posted (ESTIMATE)

February 5, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2013

Last Update Submitted That Met QC Criteria

March 11, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01 AT000162-01M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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