Ginkgo Biloba Prevention Trial in Older Individuals

Dementia Clinical Trial

Official title:

Ginkgo Biloba Prevention Trial in Older Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00010803
• Other study ID #: U01 AT000162-01M
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2001
• Last updated: March 11, 2013
• Start date: October 2000
• Est. completion date: July 2011

Study information

• Verified date: March 2013
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Other known NCT identifiers

• NCT00004535

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3069
• Est. completion date: July 2011
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Non-demented participants

• 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:

• Currently on anticoagulant therapy

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Drug:
• Ginkgo biloba
120mg twice a day
• Placebo
One pill twice daily

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Pittsburgh/University of Virginia	Charlottesville	Virginia
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of California, Davis	Sacramento	California
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (5)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)	National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. Epub 2006 Apr 19. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jul 4. — View Citation

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( — View Citation

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. — View Citation

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. Epub 2005 Oct 12. — View Citation

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. — View Citation

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. — View Citation

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. JAM — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up	Yes
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	6 months	No
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).	6 months/annually	No

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