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	Treatment or Intervention	Phase
Dementia Alzheimer's Disease	Drug: Ginkgo biloba	Phase III

Further Study Details: 

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 5 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, neuro exam, MRI, functional measurements, and review by a central adjudication committee and classified by DSM IV, NINCDS criteria and ADRTC criteria for vascular disease.

Ages Eligible for Study:  75 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Non-demented participants
• Willing to participate in a six-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

California
      University of California, Davis, Sacramento,  California,  95817,  United States
Maryland
      Johns Hopkins University, Hagerstown,  Maryland,  United States
North Carolina
      Wake Forest University School of Medicine, Winston Salem,  North Carolina,  27157-1063,  United States
Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15260,  United States

Study chairs or principal investigators

Steven T. DeKosky, M.D.,  Principal Investigator,  University of Pittsburgh, Department of Neurology   

Study ID Numbers:  1 U01 AT00162-01M; 1 U01 AT00162-01
Record last reviewed:  October 2004
Last Updated:  October 28, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010803
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08