Ginkgo Biloba Prevention Trial in Older Individuals

NCT00010803 | Completed Phase 3 Results DMC

• 2 other identifiers: U01 AT000162-01MU01AT000162-01
• Study Type: interventional
• Target: 3,069
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Dementia; Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of Participants With the Indicated Cardiovascular Disease or Mortality

  6 months

• Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance.

  6 months/annually

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo 1 pill twice a day

Drug: Placebo

Ginkgo biloba

ACTIVE COMPARATOR

Ginkgo biloba EGb761 120 mg twice daily

Drug: Ginkgo biloba

Interventions

Ginkgo biloba DRUG

120mg twice a day

Also known as: EGb761

Ginkgo biloba

Placebo DRUG

One pill twice daily

Also known as: Identical appearance as Ginkgo biloba pill

Placebo

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (5)

University of California, Davis

Sacramento, California, 95817, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157-1063, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh/University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (13)

• 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.

  PMID: 16949348 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.

  PMID: 16627007 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.

  PMID: 18000144 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.

  PMID: 17087700 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.

  PMID: 15820233 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.

  PMID: 16226041 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.

  PMID: 18165850 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.

  PMID: 19279031 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.

  PMID: 19347684 BACKGROUND

• 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.

  PMID: 19017911 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.

  PMID: 20123670 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.

  RESULT

• 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.

  PMID: 20040554 DERIVED

Related Links

• Click here to learn more about The Ginkgo Evaluation of Memory Study

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Interventions

Ginkgo Extract; Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Steven T. DeKosky MD
• Organization: University of Virginia

SD3ZC@hscmail.mcc.virginia.edu

434-924-5118

Study Officials

• Steven T. DeKosky, M.D.

  University of Pittsburgh, Department of Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: February 5, 2001
• Study Start: October 1, 2000
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2011
• Last Updated: March 14, 2013
• Results First Posted: September 16, 2010

Record last verified: 2013-03

Locations

US (5)