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 visi…
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APOE*4 is associated with increased risk and earlier age-at-onset of Alzheimer's disease, while APOE*2 is associated with decreased risk and later age-at-onset compared to APOE*3.
“of which APOE*4 is associated with an increased risk and earlier age-at-onset (AAO) of Alzheimer’s disease (AD), while APOE*2 is associated with decreased risk and later AAO of AD as compared to the wild type APOE*3 [2–6]”
From Investigation of the independent role of a rare APOE variant (L28P; APOE*4Pittsburgh) in late-onset Alzheimer disease (2023) · cites this paper as [6]
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- Authors
- DeKosky, S. T., Fitzpatrick, A., Ives, D. G., Saxton, J., Williamson, J., Lopez, O. L., Burke, G., Fried, L., Kuller, L. H., Robbins, J., Tracy, R., Woolard, N., Dunn, L., Kronmal, R., Nahin, R., & Furberg, C.
- Affiliations
- University of Pittsburgh (US)
- University of Washington (US)
- Wake Forest University Health Sciences (US)
- Johns Hopkins University (US)
- University of California, Davis (US)
- University of Vermont (US)
- National Institutes of Health (US)
- Corresponding author
- DeKosky, Steven T.
- ORCID
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2006-06
- Volume
- 27
- Issue
- 3
- Pages
- 238-253
- ISSN
- 1551-7144 (ISSN-L)
- OpenAlex
- W2090161678
- Cited by
- 176
- References
- 5
- Citations by year
- 2026: 1 · 2025: 5 · 2024: 4 · 2023: 7 · 2022: 10 · 2021: 8 · 2020: 9 · 2019: 7 · 2018: 6 · 2017: 3 · 2016: 4 · 2015: 3 · 2014: 8 · 2013: 12 · 2012: 8
- FWCI
- 52.32
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Contemporary Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Wake Forest University
- University of Washington
- Johns Hopkins University
- University of Pittsburgh
- National Center for Complementary and Integrative Health (U01AT000162)
- Topics
- Health Sciences › Medicine › Complementary and alternative medicine › Ginkgo biloba and Cashew Applications
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Keywords
- Ginkgo biloba extract EGb 761, dementia prevention, Alzheimer's disease, mild cognitive impairment, older adults, cognitive decline, functional decline, neuropsychological assessment, dementia incidence, mortality, safety monitoring
- MeSH terms
- Ginkgo Extract, Aged, Aged, 80 and over, Cognition, Dementia, Female, Humans, Male, Phytotherapy, Neuropsychological Tests, Plant Extracts, Research Design, Randomized Controlled Trials as Topic, Patient Selection, Ginkgo biloba
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