• 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 ]

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.

• Dementia
• Alzheimer's Disease

• Kleijnen J, Knipschild P. Ginkgo biloba for cerebral insufficiency. Br J Clin Pharmacol. 1992 Oct;34(4):352-8. Review.
• Hopfenmüller W. [Evidence for a therapeutic effect of Ginkgo biloba special extract. Meta-analysis of 11 clinical studies in patients with cerebrovascular insufficiency in old age] Arzneimittelforschung. 1994 Sep;44(9):1005-13. German.
• Le Bars PL, Katz MM, Berman N, Itil TM, Freedman AM, Schatzberg AF. A placebo-controlled, double-blind, randomized trial of an extract of Ginkgo biloba for dementia. North American EGb Study Group. JAMA. 1997 Oct 22-29;278(16):1327-32.
• DeKosky ST, Williamson JD, Fitzpatrick AL, Kronmal RA, Ives DG, Saxton JA, Lopez OL, Burke G, Carlson MC, Fried LP, Kuller LH, Robbins JA, Tracy RP, Woolard NF, Dunn L, Snitz BE, Nahin RL, Furberg CD; Ginkgo Evaluation of Memory (GEM) Study Investigators. Ginkgo biloba for prevention of dementia: a randomized controlled trial. JAMA. 2008 Nov 19;300(19):2253-62.

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

• 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)