| ID | Type | Description | Link |
|---|---|---|---|
| U01AT000162-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Office of Dietary Supplements (ODS) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| National Institute on Aging (NIA) | NIH |
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This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence of dementia and specifically Alzheimer's disease (AD), slowing cognitive decline and functional disability, reducing incidence of cardiovascular disease, and decreasing total mortality.
Participants will be studied in a randomized trial of 240 mg of Ginkgo biloba as compared to placebo in healthy men and women, at least 75 years old. The trial will last approximately 8 years. The intervention will be considered unsuccessful in those participants who succumb to dementia, including Alzheimer's Disease and vascular dementia. There are four clinical centers: Pittsburgh, PA; Hagerstown, MD; Winston-Salem, NC; and Sacramento, CA; and a Coordinating Center at the University of Washington, Seattle. There will be a clinic visit every 6 months to determine morbidity, mortality and change in cognition that will include repeat of ADAS, CDR, and 10 battery neuropsychological evaluation and informant interview. The primary endpoint is dementia, specifically Alzheimer's disease, secondary endpoint will include the incidence of vascular disease, changes in cognitive function scores over time, total mortality and changes in functional status. The diagnosis of dementia will be based on neuropsychological testing, neurological exam, MRI, functional measurements, and review by a central adjudication committee and classified by DSM IV, NINCDS criteria and ADRTC criteria for vascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo 1 pill twice a day |
|
| Ginkgo biloba | Active Comparator | Ginkgo biloba EGb761 120 mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginkgo biloba | Drug | 120mg twice a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Incident Dementia | All cause dementia based on DSM-IV criteria as determined by an expert panel of clinicians using an adjudication process. A full neuropsychological battery was administered annually, or at 6 month visit if there was a diagnosis of dementia or initiation of medication for dementia by private physician, or change in Modified Mini Mental State Exam (3MSE), Clinical Dementia Rating (CDR), or Alzheimer Disease Assessment Scale (ADAS-Cog). Decline on tests scores based on an algorithm resulted in a neurological exam and brain imaging. These data were used in the adjudication process. | Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Indicated Cardiovascular Disease or Mortality | Myocardial infarction (MI), angina, stroke (CVA), transient ischemic attack (TIA), combined coronary heart disease (CHD) (MI/angina), combined cerebrovascular (CVA/TIA), peripheral vascular disease, and mortality | 6 months |
| Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven T. DeKosky, M.D. | University of Pittsburgh, Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | United States | ||
| Johns Hopkins University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16949348 | Background | 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. | |
| 16627007 | Background | 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. |
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After mailing brochures to potential participants, we conducted a telephone screening followed by an in-person clinic visit to finalize eligibility. Randomization was done at a second visit within close proximity to the screening visit.
Recruitment occured between September 2000 through June 2002 primarily using mass mailings from targeted lists such as voter's registration and commercially available lists. Some sites chose to supplement this approach with newspaper, radio and television ads plus newsletter articles, posters and community presentations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ginkgo Biloba | EGb 761 Ginkgo biloba 120 mg twice daily |
| FG001 | Placebo | Placebo twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ginkgo Biloba | 120 mg twice daily, total 240 mg |
| BG001 | Placebo | Placebo 1 pill twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Incident Dementia | All cause dementia based on DSM-IV criteria as determined by an expert panel of clinicians using an adjudication process. A full neuropsychological battery was administered annually, or at 6 month visit if there was a diagnosis of dementia or initiation of medication for dementia by private physician, or change in Modified Mini Mental State Exam (3MSE), Clinical Dementia Rating (CDR), or Alzheimer Disease Assessment Scale (ADAS-Cog). Decline on tests scores based on an algorithm resulted in a neurological exam and brain imaging. These data were used in the adjudication process. | Subjects developing incident dementia during trial in each group, intention to treat (ITT). | Posted | Feb 2009 | Number | Participants | Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up |
|
Adverse event data were collected every six months at testing visits, and at interim 3 month adherence phone calls.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ginkgo Biloba | EGb 761 Ginkgo biloba 120 mg twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | COSTART | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| non-hospitalized self-reported symptom | General disorders | COSTART | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven T. DeKosky MD | University of Virginia | 434-924-5118 | SD3ZC@hscmail.mcc.virginia.edu |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D000096983 | Ginkgo Extract |
| C063170 | Ginkgo biloba extract |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
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| National Heart, Lung, and Blood Institute (NHLBI) |
| NIH |
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| Placebo | Drug | One pill twice daily |
|
|
Rate of annual change by cognitive domain in standardized Z-score scale. Higher Z-scores indicate worse performance. Best score = -2.0 Z-score change per year (improvement); worse score = 2.0 Z-score change per year (decline). |
| 6 months/annually |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157-1063 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Pittsburgh/University of Virginia | Charlottesville | Virginia | 22908 | United States |
| 18000144 | Background | 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. |
| 17087700 | Background | 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. |
| 15820233 | Background | 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. |
| 16226041 | Background | 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. |
| 18165850 | Background | 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. |
| 19279031 | Background | 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. |
| 19347684 | Background | 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. |
| 19017911 | Result | 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. |
| 20123670 | Result | 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. |
| Result | 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. |
| 20040554 | Derived | 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. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
120 mg twice daily, total 240 mg
| OG001 | Placebo | Placebo 1 pill twice a day |
|
|
|
| Secondary | Number of Participants With the Indicated Cardiovascular Disease or Mortality | Myocardial infarction (MI), angina, stroke (CVA), transient ischemic attack (TIA), combined coronary heart disease (CHD) (MI/angina), combined cerebrovascular (CVA/TIA), peripheral vascular disease, and mortality | Total cohort of 3069 based on same design as primary outcome, ITT. | Posted | Nov 2009 | Number | Participants | 6 months |
|
|
|
|
| Secondary | Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance. | Rate of annual change by cognitive domain in standardized Z-score scale. Higher Z-scores indicate worse performance. Best score = -2.0 Z-score change per year (improvement); worse score = 2.0 Z-score change per year (decline). | Final test scores were imputed for participants who did not have a cognitive exam during the year before death (n=234) or dropout (n=154) or during the month before censoring for dementia (n=70). Factors in imputed model included treatment group, demographic and health history variables, study site, and other cognitive scores. Higher Z-scores worse | Posted | Nov 2009 | Mean | 95% Confidence Interval | Z-score units | 6 months/annually |
|
|
|
|
| 1,000 |
| 1,545 |
| 1,504 |
| 1,545 |
| EG001 | Placebo | Placebo twice daily | 961 | 1,524 | 1,469 | 1,524 |
| Bleeding | General disorders | COSTART | Systematic Assessment | Gastrointestinal and all other |
|
| Coronary Heart Disease Total | Vascular disorders | COSTART | Systematic Assessment | Myocardial infarction, angina, angioplasty, coronary artery bypass graft, coronary heart disease death |
|
| Stroke | Vascular disorders | COSTART | Systematic Assessment | Ischemic, hemorrhagic and unknown |
|
| All other SAEs | General disorders | COSTART | Systematic Assessment |
|
| All adverse events | General disorders | COSTART | Systematic Assessment | There were no statistically significant differences. |
|
| Self-reported non-hospitalized symptom collected every 6 months | General disorders | COSTART | Systematic Assessment |
|
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| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| Incident MI |
|
| Incident Angina |
|
| Incident CHD (MI &/or angina) |
|
| Incident CHF |
|
| Incident Stroke |
|
| Incident TIA |
|
| Incident CVD (stroke &/or TIA) |
|
| Total CHD and CVD |
|
| Log Rank |
| 0.78 |
| Hazard Ratio (HR) |
| 1.06 |
| 2-Sided |
| 95 |
| 0.70 |
| 1.62 |
| Yes |
| Non-Inferiority or Equivalence |
Previously provided |
| Incident Myocardial Infarction | Log Rank | 0.54 | Hazard Ratio (HR) | 1.12 | 2-Sided | 95 | 0.79 | 1.58 | Yes | Non-Inferiority or Equivalence | Previously provided |
| Incident Angina | Log Rank | 0.32 | Hazard Ratio (HR) | 0.84 | 2-Sided | 95 | 0.61 | 1.18 | Yes | Non-Inferiority or Equivalence | Previously Provided |
| Incident CHD | Log Rank | 0.66 | Hazard Ratio (HR) | 0.94 | 2-Sided | 95 | 0.72 | 1.23 | Yes | Non-Inferiority or Equivalence | Previously provided |
| Incident CHF | Log Rank | 0.48 | Hazard Ratio (HR) | 0.91 | 2-Sided | 95 | 0.71 | 1.18 | Yes | Non-Inferiority or Equivalence | Previously Provided |
| Incident Stroke | Log Rank | 0.25 | Hazard Ratio (HR) | 0.87 | 2-Sided | 95 | 0.52 | 1.45 | Yes | Non-Inferiority or Equivalence | Previously provided |
| Incident TIA | Log Rank | 0.59 | Hazard Ratio (HR) | 0.87 | 2-Sided | 95 | 0.52 | 1.45 | Yes | Non-Inferiority or Equivalence | Previously provided |
| Incident CVD | Log Rank | 0.42 | Cox Proportional Hazard | 1.12 | 2-Sided | 95 | 0.84 | 1.50 | Yes | Non-Inferiority or Equivalence | Previously provided |
| Total CHD and CVD combined | Log Rank | 0.98 | Hazard Ratio (HR) | 1.00 | 2-Sided | 95 | 0.80 | 1.25 | Yes | Non-Inferiority or Equivalence | Previously provided |
| Attention (mean Z-score of 2 attention tests) |
|
| Visuospatial Abilities (mean Z-score of 2 tests) |
|
| Language (mean Z-score of 2 language tests) |
|
| Executive Functions (mean Z-score of 2 tests) |
|