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- Title
Ginkgo biloba for prevention of dementia: a randomized controlled trial.
- Authors
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; DeKosky, Steven T
- Abstract
<bold>Context: </bold>Ginkgo biloba is widely used for its potential effects on memory and cognition. To date, adequately powered clinical trials testing the effect of G. biloba on dementia incidence are lacking.<bold>Objective: </bold>To determine effectiveness of G. biloba vs placebo in reducing the incidence of all-cause dementia and Alzheimer disease (AD) in elderly individuals with normal cognition and those with mild cognitive impairment (MCI).<bold>Design, Setting, and Participants: </bold>Randomized, double-blind, placebo-controlled clinical trial conducted in 5 academic medical centers in the United States between 2000 and 2008 with a median follow-up of 6.1 years. Three thousand sixty-nine community volunteers aged 75 years or older with normal cognition (n = 2587) or MCI (n = 482) at study entry were assessed every 6 months for incident dementia.<bold>Intervention: </bold>Twice-daily dose of 120-mg extract of G. biloba (n = 1545) or placebo (n = 1524).<bold>Main Outcome Measures: </bold>Incident dementia and AD determined by expert panel consensus.<bold>Results: </bold>Five hundred twenty-three individuals developed dementia (246 receiving placebo and 277 receiving G. biloba) with 92% of the dementia cases classified as possible or probable AD, or AD with evidence of vascular disease of the brain. Rates of dropout and loss to follow-up were low (6.3%), and the adverse effect profiles were similar for both groups. The overall dementia rate was 3.3 per 100 person-years in participants assigned to G. biloba and 2.9 per 100 person-years in the placebo group. The hazard ratio (HR) for G. biloba compared with placebo for all-cause dementia was 1.12 (95% confidence interval [CI], 0.94-1.33; P = .21) and for AD, 1.16 (95% CI, 0.97-1.39; P = .11). G. biloba also had no effect on the rate of progression to dementia in participants with MCI (HR, 1.13; 95% CI, 0.85-1.50; P = .39).<bold>Conclusions: </bold>In this study, G. biloba at 120 mg twice a day was not effective in reducing either the overall incidence rate of dementia or AD incidence in elderly individuals with normal cognition or those with MCI. Trial Registration clinicaltrials.gov Identifier: NCT00010803.
- Publication
JAMA: Journal of the American Medical Association, 2008, Vol 300, Issue 19, p2253
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2008.683