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Ginkgo Biloba Prevention Trial in Older Individuals

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010803
First received: February 2, 2001
Last updated: March 11, 2013
Last verified: March 2013

February 2, 2001
March 11, 2013
October 2000
April 2008   (final data collection date for primary outcome measure)
Number of Participants With Incident Dementia [ Time Frame: Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up ] [ Designated as safety issue: Yes ]
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.
Not Provided
Complete list of historical versions of study NCT00010803 on ClinicalTrials.gov Archive Site
  • Number of Participants With the Indicated Cardiovascular Disease or Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
Not Provided
Not Provided
Not Provided
 
Ginkgo Biloba Prevention Trial in Older Individuals
Ginkgo Biloba Prevention Trial in Older Individuals

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Dementia
  • Alzheimer's Disease
  • Drug: Ginkgo biloba
    120mg twice a day
    Other Name: EGb761
  • Drug: Placebo
    One pill twice daily
    Other Name: Identical appearance as Ginkgo biloba pill
  • Placebo Comparator: Placebo
    Placebo 1 pill twice a day
    Intervention: Drug: Placebo
  • Active Comparator: Ginkgo biloba
    Ginkgo biloba EGb761 120 mg twice daily
    Intervention: Drug: Ginkgo biloba

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3069
July 2011
April 2008   (final data collection date for primary outcome measure)

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
Both
75 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010803
U01 AT000162-01M
Yes
National Center for Complementary and Alternative Medicine (NCCAM)
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)
Principal Investigator: Steven T. DeKosky, M.D. University of Pittsburgh, Department of Neurology
National Center for Complementary and Alternative Medicine (NCCAM)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP