Ginkgo Biloba Prevention Trial in Older Individuals

Phase 3

Completed

• Conditions: Dementia; Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: Ginkgo biloba

• Registration Number: NCT00010803
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Brief 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.

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 Timeline

• Study Start: 2000-10
• Study First Submitted: 2001-02-02
• Study First Submitted QC: 2001-02-02
• Study First Posted: 2001-02-05
• Primary Completion: 2008-04
• Results First Submitted: 2009-03-27
• Results First Submitted QC: 2010-08-23
• Results First Posted: 2010-09-16
• Study Completion: 2011-07
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3069

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 1 pill twice a day
Ginkgo biloba	Ginkgo biloba	Ginkgo biloba EGb761 120 mg twice daily

Primary Outcome Measures

Name	Time	Method
Number of Participants With Incident Dementia	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With the Indicated Cardiovascular Disease or Mortality	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
Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance.	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).

Trial Locations

Locations (5)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States

Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States

University of Pittsburgh/University of Virginia; 🇺🇸 Charlottesville, Virginia, United States