Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3069 participants
INTERVENTIONAL
2000-10-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo
Placebo 1 pill twice a day
Placebo
One pill twice daily
Ginkgo biloba
Ginkgo biloba EGb761 120 mg twice daily
Ginkgo biloba
120mg twice a day
Interventions
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Ginkgo biloba
120mg twice a day
Placebo
One pill twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to participate in a seven-year follow-up trial of Ginkgo Biloba
* English is their usual language
* Willing informant who has frequent contact with the participant
Exclusion Criteria
* Cancer diagnosed and treated within the past two years (except for skin cancer)
* Participant with class III - IV congestive heart failure
* Currently being treated with psychopharmacological drugs for depression
* Hospitalized for depression within the last year
* Taking Aricept (or similar agents) for cognitive problems or dementia
* Baseline blood creatinine \>2
* Baseline SGGT is a marker of liver function (3 x normal\>or=90 IU)
* Baseline hematocrit\<30
* Baseline white blood count\>or=15,000
75 Years
ALL
Yes
Sponsors
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Office of Dietary Supplements (ODS)
NIH
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
National Institute on Aging (NIA)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
Responsible Party
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Principal Investigators
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Steven T. DeKosky, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh, Department of Neurology
Locations
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University of California, Davis
Sacramento, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Pittsburgh/University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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Fitzpatrick AL, Fried LP, Williamson J, Crowley P, Posey D, Kwong L, Bonk J, Moyer R, Chabot J, Kidoguchi L, Furberg CD, DeKosky ST; GEM Study Investigators. Recruitment of the elderly into a pharmacologic prevention trial: the Ginkgo Evaluation of Memory Study experience. Contemp Clin Trials. 2006 Dec;27(6):541-53. doi: 10.1016/j.cct.2006.06.007. Epub 2006 Jul 4.
DeKosky ST, Fitzpatrick A, Ives DG, Saxton J, Williamson J, Lopez OL, Burke G, Fried L, Kuller LH, Robbins J, Tracy R, Woolard N, Dunn L, Kronmal R, Nahin R, Furberg C; GEMS Investigators. 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 Jun;27(3):238-53. doi: 10.1016/j.cct.2006.02.007. Epub 2006 Apr 19.
Fitzpatrick AL, Buchanan CK, Nahin RL, Dekosky ST, Atkinson HH, Carlson MC, Williamson JD; Ginkgo Evaluation of Memory (GEM) Study Investigators. Associations of gait speed and other measures of physical function with cognition in a healthy cohort of elderly persons. J Gerontol A Biol Sci Med Sci. 2007 Nov;62(11):1244-51. doi: 10.1093/gerona/62.11.1244.
Nahin RL, Fitzpatrick AL, Williamson JD, Burke GL, Dekosky ST, Furberg C; GEM Study Investigators. Use of herbal medicine and other dietary supplements in community-dwelling older people: Baseline data from the ginkgo evaluation of memory study. J Am Geriatr Soc. 2006 Nov;54(11):1725-35. doi: 10.1111/j.1532-5415.2006.00942.x.
Rosano C, Aizenstein HJ, Cochran JL, Saxton JA, De Kosky ST, Newman AB, Kuller LH, Lopez OL, Carter CS. Event-related functional magnetic resonance imaging investigation of executive control in very old individuals with mild cognitive impairment. Biol Psychiatry. 2005 Apr 1;57(7):761-7. doi: 10.1016/j.biopsych.2004.12.031.
Rosano C, Aizenstein H, Cochran J, Saxton J, De Kosky S, Newman AB, Kuller LH, Lopez OL, Carter CS. Functional neuroimaging indicators of successful executive control in the oldest old. Neuroimage. 2005 Dec;28(4):881-9. doi: 10.1016/j.neuroimage.2005.05.059. Epub 2005 Oct 12.
Williamson JD, Vellas B, Furberg C, Nahin R, Dekosky ST. Comparison of the design differences between the Ginkgo Evaluation of Memory study and the GuidAge study. J Nutr Health Aging. 2008 Jan;12(1):73S-9S. doi: 10.1007/BF02982591.
Saxton J, Snitz BE, Lopez OL, Ives DG, Dunn LO, Fitzpatrick A, Carlson MC, Dekosky ST; GEM Study Investigators. Functional and cognitive criteria produce different rates of mild cognitive impairment and conversion to dementia. J Neurol Neurosurg Psychiatry. 2009 Jul;80(7):737-43. doi: 10.1136/jnnp.2008.160705. Epub 2009 Mar 11.
Snitz BE, Saxton J, Lopez OL, Ives DG, Dunn LO, Rapp SR, Carlson MC, Fitzpatrick AL, Dekosky ST; GEM study Investigators. Identifying mild cognitive impairment at baseline in the Ginkgo Evaluation of Memory (GEM) study. Aging Ment Health. 2009 Mar;13(2):171-82. doi: 10.1080/13607860802380656.
DeKosky ST, Williamson JD, Fitzpatrick AL, Kronmal RA, Ives DG, Saxton JA, Lopez OL, Burke G, Carlson MC, Fried LP, Kuller LH, Robbins JA, Tracy RP, Woolard NF, Dunn L, Snitz BE, Nahin RL, Furberg CD; Ginkgo Evaluation of Memory (GEM) Study Investigators. Ginkgo biloba for prevention of dementia: a randomized controlled trial. JAMA. 2008 Nov 19;300(19):2253-62. doi: 10.1001/jama.2008.683.
Kuller LH, Ives DG, Fitzpatrick AL, Carlson MC, Mercado C, Lopez OL, Burke GL, Furberg CD, DeKosky ST; Ginkgo Evaluation of Memory Study Investigators. Does Ginkgo biloba reduce the risk of cardiovascular events? Circ Cardiovasc Qual Outcomes. 2010 Jan;3(1):41-7. doi: 10.1161/CIRCOUTCOMES.109.871640. Epub 2009 Nov 24.
Snitz BE, O'Meara ES, Carlson MC, Arnold A, Ives DG, Rapp SR, Saxton J, Lopez OL, Dunn LO, Sink K, DeKosky ST for the Ginkgo Evaluation of Memory Study investigators. Ginkgo biloba in preventing cognitive decline in older adults: A randomized trial. Journal of the American Medical Aassociation, 2009, in press.
Snitz BE, O'Meara ES, Carlson MC, Arnold AM, Ives DG, Rapp SR, Saxton J, Lopez OL, Dunn LO, Sink KM, DeKosky ST; Ginkgo Evaluation of Memory (GEM) Study Investigators. Ginkgo biloba for preventing cognitive decline in older adults: a randomized trial. JAMA. 2009 Dec 23;302(24):2663-70. doi: 10.1001/jama.2009.1913.
Related Links
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Click here to learn more about The Ginkgo Evaluation of Memory Study
Other Identifiers
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U01 AT000162-01M
Identifier Type: -
Identifier Source: org_study_id
NCT00004535
Identifier Type: -
Identifier Source: nct_alias
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