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ID: 10277
Title:Ginkgo Evaluation of Memory (GEM) Study: Design and Baseline Data of a Randomized Trial of Ginkgo Biloba Extract in Prevention of Dementia.
Publication Year: 2006.
Format(s): Journal Article , Funded Research
Language(s): English
Audience(s): Physicians , Psychiatrists , Neurologists , Geriatricians
Author(s): DeKosky, S.T., et al.
Source: Contemporary Clinical Trials. 27(3): 238-253. June 2006. Epub 2006 April 19.

Abstract: This journal article describes the design and baseline data of the Ginkgo Evaluation of Memory (GEM) study. The study was initially designed as a 5-year, randomized, double-blind, placebo-controlled trial of Ginkgo biloba extract, administered in a dose of 120 mg twice per day as Egb761, in the prevention of dementia and Alzheimer’s disease in normal elderly and those with mild cognitive impairment. The researchers anticipate 8.5 years of participant follow-up. Initial power calculations based on estimates of incidence rates of dementia in the target population (age 75 and older) led to a sample size of 3,000, which was successfully recruited at four clinical sites across the United States from September 2000 to June 2002. Primary outcome is incidence of all-cause dementia, and secondary outcomes include rate of cognitive and functional decline, incidence of cardiovascular and cerebrovascular events, and mortality. Following screening to exclude participants with incident dementia at baseline, an extensive neuropsychological assessment was performed and participants were randomly assigned to treatment groups. All participants were required to have a proxy who could provide an independent assessment of the participant’s functional and cognitive abilities. Assessments are repeated every 6 months. Significant decline at any visit leads to a repeat neuropsychological battery, neurological and medical evaluations, and MRI scan of the brain. A panel of experts will make the final diagnosis of dementia, and side effects and adverse events will be tracked. 3 figures, 8 tables, 57 references. AA-M.

Major Descriptor(s): DEMENTIA , ALZHEIMERS-DISEASE , GINKGO-BILOBA , CLINICAL-TRIALS , PREVENTION , ALTERNATIVE-MEDICINE , HERBAL-MEDICINE , RESEARCH-METHODOLOGY
Minor Descriptor(s): LONGITUDINAL-STUDIES

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