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The Ginkgo Evaluation of Memory (GEM) study: design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia.
Contemp Clin Trials 2006; 27(3):238-53CC

Abstract

The epidemic of late life dementia, prominence of use of alternative medications and supplements, and initiation of efforts to determine how to prevent dementia have led to efforts to conduct studies aimed at prevention of dementia. The GEM (Ginkgo Evaluation of Memory) study was initially designed as a 5-year, randomized double-blind, placebo-controlled trial of Ginkgo biloba, administered in a dose of 120 mg twice per day as EGb761, in the prevention of dementia (and especially Alzheimer's disease) in normal elderly or those with mild cognitive impairment. The study anticipates 8.5 years of participant follow-up. Initial power calculations based on estimates of incidence rates of dementia in the target population (age 75+) led to a 3000-person study, which was successfully recruited at four clinical sites around the United States from September 2000 to June 2002. Primary outcome is incidence of all-cause dementia; secondary outcomes include rate of cognitive and functional decline, the 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 are required to have a proxy who agreed to provide an independent assessment of the functional and cognitive abilities of the participant. Assessments are repeated every 6 months. Significant decline at any visit, defined by specific changes in cognitive screening scores, leads to a repeat detailed neuropsychological battery, neurological and medical evaluation and MRI scan of the brain. The final diagnosis of dementia is achieved by a consensus panel of experts. Side effects and adverse events are tracked by computer at the central data coordinating center and unblinded data are reviewed by an independent safety monitoring board. Studies such as these are necessary for this and a variety of other potential protective agents to evaluate their effectiveness in preventing or slowing the emergence of dementia in the elderly population.

Authors+Show Affiliations

Department of Neurology, University of Pittsburgh, 3471 Fifth Avenue, Suite 811, Pittsburgh, PA 15213, USA. DeKoskyST@upmc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

16627007

Citation

DeKosky, Steven T., et al. "The Ginkgo Evaluation of Memory (GEM) Study: Design and Baseline Data of a Randomized Trial of Ginkgo Biloba Extract in Prevention of Dementia." Contemporary Clinical Trials, vol. 27, no. 3, 2006, pp. 238-53.
DeKosky ST, Fitzpatrick A, Ives DG, et al. The Ginkgo Evaluation of Memory (GEM) study: design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia. Contemp Clin Trials. 2006;27(3):238-53.
DeKosky, S. T., Fitzpatrick, A., Ives, D. G., Saxton, J., Williamson, J., Lopez, O. L., ... Furberg, C. (2006). The Ginkgo Evaluation of Memory (GEM) study: design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia. Contemporary Clinical Trials, 27(3), pp. 238-53.
DeKosky ST, et al. The Ginkgo Evaluation of Memory (GEM) Study: Design and Baseline Data of a Randomized Trial of Ginkgo Biloba Extract in Prevention of Dementia. Contemp Clin Trials. 2006;27(3):238-53. PubMed PMID: 16627007.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Ginkgo Evaluation of Memory (GEM) study: design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia. AU - DeKosky,Steven T, AU - Fitzpatrick,Annette, AU - Ives,Diane G, AU - Saxton,Judith, AU - Williamson,Jeff, AU - Lopez,Oscar L, AU - Burke,Gregory, AU - Fried,Linda, AU - Kuller,Lewis H, AU - Robbins,John, AU - Tracy,Russell, AU - Woolard,Nancy, AU - Dunn,Leslie, AU - Kronmal,Richard, AU - Nahin,Richard, AU - Furberg,Curt, AU - ,, Y1 - 2006/04/19/ PY - 2005/04/20/received PY - 2006/01/16/revised PY - 2006/02/24/accepted PY - 2006/4/22/pubmed PY - 2006/10/27/medline PY - 2006/4/22/entrez SP - 238 EP - 53 JF - Contemporary clinical trials JO - Contemp Clin Trials VL - 27 IS - 3 N2 - The epidemic of late life dementia, prominence of use of alternative medications and supplements, and initiation of efforts to determine how to prevent dementia have led to efforts to conduct studies aimed at prevention of dementia. The GEM (Ginkgo Evaluation of Memory) study was initially designed as a 5-year, randomized double-blind, placebo-controlled trial of Ginkgo biloba, administered in a dose of 120 mg twice per day as EGb761, in the prevention of dementia (and especially Alzheimer's disease) in normal elderly or those with mild cognitive impairment. The study anticipates 8.5 years of participant follow-up. Initial power calculations based on estimates of incidence rates of dementia in the target population (age 75+) led to a 3000-person study, which was successfully recruited at four clinical sites around the United States from September 2000 to June 2002. Primary outcome is incidence of all-cause dementia; secondary outcomes include rate of cognitive and functional decline, the 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 are required to have a proxy who agreed to provide an independent assessment of the functional and cognitive abilities of the participant. Assessments are repeated every 6 months. Significant decline at any visit, defined by specific changes in cognitive screening scores, leads to a repeat detailed neuropsychological battery, neurological and medical evaluation and MRI scan of the brain. The final diagnosis of dementia is achieved by a consensus panel of experts. Side effects and adverse events are tracked by computer at the central data coordinating center and unblinded data are reviewed by an independent safety monitoring board. Studies such as these are necessary for this and a variety of other potential protective agents to evaluate their effectiveness in preventing or slowing the emergence of dementia in the elderly population. SN - 1551-7144 UR - https://www.unboundmedicine.com/medline/citation/16627007/The_Ginkgo_Evaluation_of_Memory__GEM__study:_design_and_baseline_data_of_a_randomized_trial_of_Ginkgo_biloba_extract_in_prevention_of_dementia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1551-7144(06)00008-5 DB - PRIME DP - Unbound Medicine ER -