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Ginkgo Biloba Prevention Trial in Older Individuals

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: National Center for Complementary and Alternative Medicine (NCCAM)
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
Phase III

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Disease    Dementia   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Ginkgo Biloba Prevention Trial in Older Individuals

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Dementia [ Time Frame: 6 months/annually ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Cardiovascular disease [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Progression of cognitive decline [ Time Frame: 6 months/annually ] [ Designated as safety issue: Yes ]

Enrollment:   3069
Study Start Date:   October 2000
Estimated Study Completion Date:   July 2010
Primary Completion Date:   April 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Placebo: Placebo Comparator
Placebo 1 pill twice a day
Drug: Ginkgo biloba
120 mg twice a day

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.

  Eligibility
Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

Investigators
Principal Investigator:     Steven T. DeKosky, M.D.     University of Pittsburgh, Department of Neurology    
  More Information


Click here to learn more about The Ginkgo Evaluation of Memory Study  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   University of Pittsburgh/University of Virginia ( Steven T. DeKosky MD )
Study ID Numbers:   U01 AT000162-01M, 1 U01 AT000162-01
First Received:   February 2, 2001
Last Updated:   September 24, 2008
ClinicalTrials.gov Identifier:   NCT00010803
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 20, 2008




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