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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
  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
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Ginkgo Biloba Prevention Trial in Older Individuals

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 3069
Study Start Date: October 2000
Study Completion Date: July 2011
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00010803     History of Changes
Obsolete Identifiers: NCT00004535
Other Study ID Numbers: U01 AT000162-01M
Study First Received: February 2, 2001
Results First Received: March 27, 2009
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014