Ginkgo biloba for prevention of dementia: A randomized controlled trial

Steven T. DeKosky, Jeff D. Williamson, Annette L. Fitzpatrick, Richard A. Kronmal, Diane G. Ives, Judith A. Saxton, Oscar L. Lopez, Gregory Burke, Michelle C Carlson, Linda P Fried, Lewis H. Kuller, John A. Robbins, Russell P. Tracy, Nancy F. Woolard, Leslie Dunn, Beth E. Snitz, Richard L. Nahin, Curt D. Furberg

Research output: Contribution to journalArticle

Abstract

Context: Ginkgo biloba is widely used for its potential effects on memory and cognition. To date, adequately powered clinical trials testing the effect of G biloba on dementia incidence are lacking. Objective: To determine effectiveness of G biloba vs placebo in reducing the incidence of all-cause dementia and Alzheimer disease (AD) in elderly individuals with normal cognition and those with mild cognitive impairment (MCI). Design, Setting, and Participants: Randomized, double-blind, placebo-controlled clinical trial conducted in 5 academic medical centers in the United States between 2000 and 2008 with a median follow-up of 6.1 years. Three thousand sixty-nine community volunteers aged 75 years or older with normal cognition (n=2587) or MCI (n=482) at study entry were assessed every 6 months for incident dementia. Intervention: Twice-daily dose of 120-mg extract of G biloba (n=1545) or placebo (n=1524). Main Outcome Measures: Incident dementia and AD determined by expert panel consensus. Results: Five hundred twenty-three individuals developed dementia (246 receiving placebo and 277 receiving G biloba) with 92% of the dementia cases classified as possible or probable AD, or AD with evidence of vascular disease of the brain. Rates of dropout and loss to follow-up were low (6.3%), and the adverse effect profiles were similar for both groups. The overall dementia rate was 3.3 per 100 person-years in participants assigned to G biloba and 2.9 per 100 person-years in the placebo group. The hazard ratio (HR) for G biloba compared with placebo for all-cause dementia was 1.12 (95% confidence interval [CI], 0.94-1.33; P=.21) and for AD, 1.16 (95% CI, 0.97-1.39; P=.11). G biloba also had no effect on the rate of progression to dementia in participants with MCI (HR, 1.13; 95% CI, 0.85-1.50; P=.39). Conclusions: In this study, G biloba at 120 mg twice a day was not effective in reducing either the overall incidence rate of dementia or AD incidence in elderly individuals with normal cognition or those with MCI. Trial Registration: clinicaltrials.gov Identifier: NCT00010803.

Original languageEnglish (US)
Pages (from-to)2253-2262
Number of pages10
JournalJournal of the American Medical Association
Volume300
Issue number19
DOIs
StatePublished - Nov 19 2008

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Ginkgo biloba
Dementia
Randomized Controlled Trials
Alzheimer Disease
Placebos
Cognition
Incidence
Confidence Intervals
Controlled Clinical Trials
Vascular Diseases
Volunteers
Consensus
Outcome Assessment (Health Care)
Clinical Trials

ASJC Scopus subject areas

  • Medicine(all)

Cite this

DeKosky, S. T., Williamson, J. D., Fitzpatrick, A. L., Kronmal, R. A., Ives, D. G., Saxton, J. A., ... Furberg, C. D. (2008). Ginkgo biloba for prevention of dementia: A randomized controlled trial. Journal of the American Medical Association, 300(19), 2253-2262. https://doi.org/10.1001/jama.2008.683

Ginkgo biloba for prevention of dementia : A randomized controlled trial. / DeKosky, Steven T.; Williamson, Jeff D.; Fitzpatrick, Annette L.; Kronmal, Richard A.; Ives, Diane G.; Saxton, Judith A.; Lopez, Oscar L.; Burke, Gregory; Carlson, Michelle C; Fried, Linda P; Kuller, Lewis H.; Robbins, John A.; Tracy, Russell P.; Woolard, Nancy F.; Dunn, Leslie; Snitz, Beth E.; Nahin, Richard L.; Furberg, Curt D.

In: Journal of the American Medical Association, Vol. 300, No. 19, 19.11.2008, p. 2253-2262.

Research output: Contribution to journalArticle

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 2008, 'Ginkgo biloba for prevention of dementia: A randomized controlled trial', Journal of the American Medical Association, vol. 300, no. 19, pp. 2253-2262. https://doi.org/10.1001/jama.2008.683
DeKosky ST, Williamson JD, Fitzpatrick AL, Kronmal RA, Ives DG, Saxton JA et al. Ginkgo biloba for prevention of dementia: A randomized controlled trial. Journal of the American Medical Association. 2008 Nov 19;300(19):2253-2262. https://doi.org/10.1001/jama.2008.683
DeKosky, Steven T. ; Williamson, Jeff D. ; Fitzpatrick, Annette L. ; Kronmal, Richard A. ; Ives, Diane G. ; Saxton, Judith A. ; Lopez, Oscar L. ; Burke, Gregory ; Carlson, Michelle C ; Fried, Linda P ; Kuller, Lewis H. ; Robbins, John A. ; Tracy, Russell P. ; Woolard, Nancy F. ; Dunn, Leslie ; Snitz, Beth E. ; Nahin, Richard L. ; Furberg, Curt D. / Ginkgo biloba for prevention of dementia : A randomized controlled trial. In: Journal of the American Medical Association. 2008 ; Vol. 300, No. 19. pp. 2253-2262.
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abstract = "Context: Ginkgo biloba is widely used for its potential effects on memory and cognition. To date, adequately powered clinical trials testing the effect of G biloba on dementia incidence are lacking. Objective: To determine effectiveness of G biloba vs placebo in reducing the incidence of all-cause dementia and Alzheimer disease (AD) in elderly individuals with normal cognition and those with mild cognitive impairment (MCI). Design, Setting, and Participants: Randomized, double-blind, placebo-controlled clinical trial conducted in 5 academic medical centers in the United States between 2000 and 2008 with a median follow-up of 6.1 years. Three thousand sixty-nine community volunteers aged 75 years or older with normal cognition (n=2587) or MCI (n=482) at study entry were assessed every 6 months for incident dementia. Intervention: Twice-daily dose of 120-mg extract of G biloba (n=1545) or placebo (n=1524). Main Outcome Measures: Incident dementia and AD determined by expert panel consensus. Results: Five hundred twenty-three individuals developed dementia (246 receiving placebo and 277 receiving G biloba) with 92{\%} of the dementia cases classified as possible or probable AD, or AD with evidence of vascular disease of the brain. Rates of dropout and loss to follow-up were low (6.3{\%}), and the adverse effect profiles were similar for both groups. The overall dementia rate was 3.3 per 100 person-years in participants assigned to G biloba and 2.9 per 100 person-years in the placebo group. The hazard ratio (HR) for G biloba compared with placebo for all-cause dementia was 1.12 (95{\%} confidence interval [CI], 0.94-1.33; P=.21) and for AD, 1.16 (95{\%} CI, 0.97-1.39; P=.11). G biloba also had no effect on the rate of progression to dementia in participants with MCI (HR, 1.13; 95{\%} CI, 0.85-1.50; P=.39). Conclusions: In this study, G biloba at 120 mg twice a day was not effective in reducing either the overall incidence rate of dementia or AD incidence in elderly individuals with normal cognition or those with MCI. Trial Registration: clinicaltrials.gov Identifier: NCT00010803.",
author = "DeKosky, {Steven T.} and Williamson, {Jeff D.} and Fitzpatrick, {Annette L.} and Kronmal, {Richard A.} and Ives, {Diane G.} and Saxton, {Judith A.} and Lopez, {Oscar L.} and Gregory Burke and Carlson, {Michelle C} and Fried, {Linda P} and Kuller, {Lewis H.} and Robbins, {John A.} and Tracy, {Russell P.} and Woolard, {Nancy F.} and Leslie Dunn and Snitz, {Beth E.} and Nahin, {Richard L.} and Furberg, {Curt D.}",
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T1 - Ginkgo biloba for prevention of dementia

T2 - A randomized controlled trial

AU - DeKosky, Steven T.

AU - Williamson, Jeff D.

AU - Fitzpatrick, Annette L.

AU - Kronmal, Richard A.

AU - Ives, Diane G.

AU - Saxton, Judith A.

AU - Lopez, Oscar L.

AU - Burke, Gregory

AU - Carlson, Michelle C

AU - Fried, Linda P

AU - Kuller, Lewis H.

AU - Robbins, John A.

AU - Tracy, Russell P.

AU - Woolard, Nancy F.

AU - Dunn, Leslie

AU - Snitz, Beth E.

AU - Nahin, Richard L.

AU - Furberg, Curt D.

PY - 2008/11/19

Y1 - 2008/11/19

N2 - Context: Ginkgo biloba is widely used for its potential effects on memory and cognition. To date, adequately powered clinical trials testing the effect of G biloba on dementia incidence are lacking. Objective: To determine effectiveness of G biloba vs placebo in reducing the incidence of all-cause dementia and Alzheimer disease (AD) in elderly individuals with normal cognition and those with mild cognitive impairment (MCI). Design, Setting, and Participants: Randomized, double-blind, placebo-controlled clinical trial conducted in 5 academic medical centers in the United States between 2000 and 2008 with a median follow-up of 6.1 years. Three thousand sixty-nine community volunteers aged 75 years or older with normal cognition (n=2587) or MCI (n=482) at study entry were assessed every 6 months for incident dementia. Intervention: Twice-daily dose of 120-mg extract of G biloba (n=1545) or placebo (n=1524). Main Outcome Measures: Incident dementia and AD determined by expert panel consensus. Results: Five hundred twenty-three individuals developed dementia (246 receiving placebo and 277 receiving G biloba) with 92% of the dementia cases classified as possible or probable AD, or AD with evidence of vascular disease of the brain. Rates of dropout and loss to follow-up were low (6.3%), and the adverse effect profiles were similar for both groups. The overall dementia rate was 3.3 per 100 person-years in participants assigned to G biloba and 2.9 per 100 person-years in the placebo group. The hazard ratio (HR) for G biloba compared with placebo for all-cause dementia was 1.12 (95% confidence interval [CI], 0.94-1.33; P=.21) and for AD, 1.16 (95% CI, 0.97-1.39; P=.11). G biloba also had no effect on the rate of progression to dementia in participants with MCI (HR, 1.13; 95% CI, 0.85-1.50; P=.39). Conclusions: In this study, G biloba at 120 mg twice a day was not effective in reducing either the overall incidence rate of dementia or AD incidence in elderly individuals with normal cognition or those with MCI. Trial Registration: clinicaltrials.gov Identifier: NCT00010803.

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