Ginkgo Biloba Prevention Trial in Older Individuals

Last updated: March 11, 2013
Sponsor: National Center for Complementary and Integrative Health (NCCIH)
Overall Status: Completed

Phase

3

Condition

Dementia

Memory Loss

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT00010803
U01 AT000162-01M
  • Ages > 75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 3069
Study Start date:
October 01, 2000
Estimated Completion Date:
July 31, 2011

Study 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.

Connect with a study center

  • University of California, Davis

    Sacramento, California 95817
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina 27157-1063
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Pittsburgh/University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.