Ginkgo Biloba Prevention Trial in Older Individuals

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease; Dementia

Treatments: Drug: Ginkgo biloba; Drug: Placebo

Study type: Interventional

Funder types: NIH

Identifiers

NCT00010803

U01 AT000162-01M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,069 patients

Sex: All

Ages: 75+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,069 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo 1 pill twice a day

Treatment:

Drug: Placebo

Ginkgo biloba

Active Comparator group

Description:

Ginkgo biloba EGb761 120 mg twice daily

Treatment:

Drug: Ginkgo biloba