Ginkgo biloba Prevention Trials

Abstract

JAMA Ginkgo biloba for Prevention of Dementia: A Randomized Controlled Trial Steven T. DeKosky, MD; Jeff D. Williamson, MD, MHS; Annette L. Fitzpatrick, PhD; Richard A. Kronmal, PhD; Diane G. Ives, MPH; Judith A. Saxton, MD; Oscar L. Lopez, MD; Gregory Burke, MD; Michelle C. Carlson, PhD; Linda P. Fried, MD, MPH; Lewis H. Kuller, MD, DrPH; John A. Robbins, MD, MHS; Russell P. Tracy, PhD; Nancy F. Woolard; Leslie Dunn, MPH; Beth E. Snitz, PhD; Richard L. Nahin, PhD, MPH; Curt D. Furberg, MD, PhD; for the Ginkgo Evaluation of Memory (GEM) Study Investigators Context: 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. Objective: 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). Design, Setting, and Participants: 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. Intervention: Twice-daily dose of 120-mg extract of G biloba (n = 1545) or placebo (n = 1524). Main Outcome Measures: Incident dementia and AD determined by expert panel consensus. Results: 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). Conclusions: 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 JAMA. 2008;300(19):2253-2262..