The Ginkgo Evaluation of Memory (GEM) study: Design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia

Steven T. DeKosky, Annette Fitzpatrick, Diane G. Ives, Judith Saxton, Jeff Williamson, Oscar L. Lopez, Gregory Burke, Linda Fried, Lewis H. Kuller, John A Robbins, Russell Tracy, Nancy Woolard, Leslie Dunn, Richard Kronmal, Richard Nahin, Curt Furberg

Research output: Contribution to journalArticle

125 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)238-253
Number of pages16
JournalContemporary Clinical Trials
Volume27
Issue number3
DOIs
StatePublished - Jun 2006

Fingerprint

Ginkgo biloba
Dementia
Incidence
Clinical Trials Data Monitoring Committees
Protective Agents
Aptitude
Health Services Needs and Demand
Proxy
Consensus
Alzheimer Disease
Placebos
Magnetic Resonance Imaging
Mortality

Keywords

  • Alzheimer's disease
  • Dementia
  • Ginkgo biloba
  • Primary prevention trial

ASJC Scopus subject areas

  • Pharmacology

Cite this

The Ginkgo Evaluation of Memory (GEM) study : Design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia. / DeKosky, Steven T.; Fitzpatrick, Annette; Ives, Diane G.; Saxton, Judith; Williamson, Jeff; Lopez, Oscar L.; Burke, Gregory; Fried, Linda; Kuller, Lewis H.; Robbins, John A; Tracy, Russell; Woolard, Nancy; Dunn, Leslie; Kronmal, Richard; Nahin, Richard; Furberg, Curt.

In: Contemporary Clinical Trials, Vol. 27, No. 3, 06.2006, p. 238-253.

Research output: Contribution to journalArticle

DeKosky, ST, Fitzpatrick, A, Ives, DG, Saxton, J, Williamson, J, Lopez, OL, Burke, G, Fried, L, Kuller, LH, Robbins, JA, Tracy, R, Woolard, N, Dunn, L, Kronmal, R, Nahin, R & 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, vol. 27, no. 3, pp. 238-253. https://doi.org/10.1016/j.cct.2006.02.007
DeKosky, Steven T. ; Fitzpatrick, Annette ; Ives, Diane G. ; Saxton, Judith ; Williamson, Jeff ; Lopez, Oscar L. ; Burke, Gregory ; Fried, Linda ; Kuller, Lewis H. ; Robbins, John A ; Tracy, Russell ; Woolard, Nancy ; Dunn, Leslie ; Kronmal, Richard ; Nahin, Richard ; Furberg, Curt. / The Ginkgo Evaluation of Memory (GEM) study : Design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia. In: Contemporary Clinical Trials. 2006 ; Vol. 27, No. 3. pp. 238-253.
@article{d29ba6149bfd426d8492ff992e802c16,
title = "The Ginkgo Evaluation of Memory (GEM) study: Design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia",
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.",
keywords = "Alzheimer's disease, Dementia, Ginkgo biloba, Primary prevention trial",
author = "DeKosky, {Steven T.} and Annette Fitzpatrick and Ives, {Diane G.} and Judith Saxton and Jeff Williamson and Lopez, {Oscar L.} and Gregory Burke and Linda Fried and Kuller, {Lewis H.} and Robbins, {John A} and Russell Tracy and Nancy Woolard and Leslie Dunn and Richard Kronmal and Richard Nahin and Curt Furberg",
year = "2006",
month = "6",
doi = "10.1016/j.cct.2006.02.007",
language = "English (US)",
volume = "27",
pages = "238--253",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",
number = "3",

}

TY - JOUR

T1 - The Ginkgo Evaluation of Memory (GEM) study

T2 - 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 A

AU - Tracy, Russell

AU - Woolard, Nancy

AU - Dunn, Leslie

AU - Kronmal, Richard

AU - Nahin, Richard

AU - Furberg, Curt

PY - 2006/6

Y1 - 2006/6

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.

AB - 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.

KW - Alzheimer's disease

KW - Dementia

KW - Ginkgo biloba

KW - Primary prevention trial

UR - http://www.scopus.com/inward/record.url?scp=33646205347&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33646205347&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2006.02.007

DO - 10.1016/j.cct.2006.02.007

M3 - Article

C2 - 16627007

AN - SCOPUS:33646205347

VL - 27

SP - 238

EP - 253

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

IS - 3

ER -