We are proposing to study 2000 participants in a randomized trial of 240 mg of ginkgo biloba as compared to placebo in men and women, median age of 80. Approximately 1500 participants will be recruited from current Cardiovascular Health Study (CHS) participants who had a clinic visit in 1998-99 and 500 will be recruited from the community. There are four clinical centers: Pittsburgh, Hagerstown, Winston-Salem and Sacramento, California, and a Coordinating Center at the University of Washington, Seattle. Following randomization, participants will be seen at 1 month, 4 months, 8 months and every four months thereafter during the trial for evaluation of adherence, and side effects. There will be a telephone call at every 6 months to determine morbidity and change in cognition (telephone interview for cognition (TICS), and annual examination that will include repeat of 3MSE, DSST, and 10 battery neuropsychological evaluation and informant interview. ApoE has already been measured for all CHS participants. The primary endpoint is dementia, secondary endpoint will be Alzheimer's Disease, vascular dementia, and other endpoints include incidence of vascular disease, changes in cognitive function scores over time, and changes in functional status. We are proposing a six year study. We estimate incidence of dementia at about 3.5 percent/year over six years and a total mortality of 6 percent/year. We would have about 90 percent power alpha.05 to determine a 35 percent reduction, and 80 percent power for 30 percent reduction in incidence of dementia. We estimate approximately 250 dementia cases in the study based on 3.5 percent yearly incidence. 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.
| Koch, Manja; DeKosky, Steven T; Fitzpatrick, Annette L et al. (2018) Apolipoproteins and Alzheimer's pathophysiology. Alzheimers Dement (Amst) 10:545-553 |
| Nadkarni, Neelesh K; Perera, Subashan; Snitz, Beth E et al. (2017) Association of Brain Amyloid-? With Slow Gait in Elderly Individuals Without Dementia: Influence of Cognition and Apolipoprotein E ?4 Genotype. JAMA Neurol 74:82-90 |
| Sharma, Monisha; Fitzpatrick, Annette L; Arnold, Alice M et al. (2016) Inflammatory Biomarkers and Cognitive Decline: The Ginkgo Evaluation of Memory Study. J Am Geriatr Soc 64:1171-7 |
| Callahan, Kathryn E; Lovato, James F; Miller, Michael E et al. (2015) Associations Between Mild Cognitive Impairment and Hospitalization and Readmission. J Am Geriatr Soc 63:1880-5 |
| Rosenthal, Samantha L; Bamne, Mikhil N; Wang, Xingbin et al. (2015) More evidence for association of a rare TREM2 mutation (R47H) with Alzheimer's disease risk. Neurobiol Aging 36:2443.e21-6 |
| Nichols, Noah; Bras, Jose M; Hernandez, Dena G et al. (2015) EIF4G1 mutations do not cause Parkinson's disease. Neurobiol Aging 36:2444.e1-4 |
| Tate, Judith A; Snitz, Beth E; Alvarez, Karina A et al. (2014) Infection hospitalization increases risk of dementia in the elderly. Crit Care Med 42:1037-46 |
| Lopez, Oscar L; Klunk, William E; Mathis, Chester et al. (2014) Amyloid, neurodegeneration, and small vessel disease as predictors of dementia in the oldest-old. Neurology 83:1804-11 |
| Bamne, Mikhil N; Demirci, F Yesim; Berman, Sarah et al. (2014) Investigation of an amyloid precursor protein protective mutation (A673T) in a North American case-control sample of late-onset Alzheimer's disease. Neurobiol Aging 35:1779.e15-6 |
| Yasar, Sevil; Xia, Jin; Yao, Wenliang et al. (2013) Antihypertensive drugs decrease risk of Alzheimer disease: Ginkgo Evaluation of Memory Study. Neurology 81:896-903 |
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