OBJECTIVE: To assess the feasibility, safety, and efficacy of Ginkgo biloba extract (GBE) on delaying the progression to cognitive impairment in normal elderlyaged 85 and older. METHODS: Randomized, placebo-controlled, double-blind, 42-month pilot study with 118 cognitively intact subjects randomized tostandardized GBE or placebo. Kaplan-Meier estimation, Cox proportional hazard, and random-effects models were used to compare the risk of progression from Clinical Dementia Rating (CDR) = 0 to CDR = 0.5 and decline in episodic memory function between GBE and placebo groups. RESULTS: In the intention-to-treat analysis, there was no reduced risk of progression to CDR = 0.5 (log-rank test, p = 0.06) among the GBE group. There was no less of a decline in memory function among the GBE group (p = 0.05). In the secondary analysis, where we controlled the medication adherence level, the GBE group had a lower risk of progression from CDR = 0 to CDR = 0.5 (HR = 0.33, p = 0.02), and a smaller decline in memory scores (p = 0.04). There were more ischemic strokes and TIAs in the GBE group (p = 0.01). CONCLUSIONS: In unadjusted analyses, Ginkgo biloba extract (GBE) neither altered the risk of progression from normal to Clinical Dementia Rating (CDR) = 0.5, nor protected against a decline in memory function. Secondary analysis taking into account medication adherence showed a protective effect of GBE on the progression to CDR = 0.5 and memory decline. Results of larger prevention trials taking into account medication adherence may clarify the effectiveness of GBE. More stroke and TIA cases observed among the GBE group requires further study to confirm.
RCT Entities:
OBJECTIVE: To assess the feasibility, safety, and efficacy of Ginkgo biloba extract (GBE) on delaying the progression to cognitive impairment in normal elderly aged 85 and older. METHODS: Randomized, placebo-controlled, double-blind, 42-month pilot study with 118 cognitively intact subjects randomized to standardized GBE or placebo. Kaplan-Meier estimation, Cox proportional hazard, and random-effects models were used to compare the risk of progression from Clinical Dementia Rating (CDR) = 0 to CDR = 0.5 and decline in episodic memory function between GBE and placebo groups. RESULTS: In the intention-to-treat analysis, there was no reduced risk of progression to CDR = 0.5 (log-rank test, p = 0.06) among the GBE group. There was no less of a decline in memory function among the GBE group (p = 0.05). In the secondary analysis, where we controlled the medication adherence level, the GBE group had a lower risk of progression from CDR = 0 to CDR = 0.5 (HR = 0.33, p = 0.02), and a smaller decline in memory scores (p = 0.04). There were more ischemic strokes and TIAs in the GBE group (p = 0.01). CONCLUSIONS: In unadjusted analyses, Ginkgo biloba extract (GBE) neither altered the risk of progression from normal to Clinical Dementia Rating (CDR) = 0.5, nor protected against a decline in memory function. Secondary analysis taking into account medication adherence showed a protective effect of GBE on the progression to CDR = 0.5 and memory decline. Results of larger prevention trials taking into account medication adherence may clarify the effectiveness of GBE. More stroke and TIA cases observed among the GBE group requires further study to confirm.
Authors: Steven T DeKosky; Annette Fitzpatrick; Diane G Ives; Judith Saxton; Jeff Williamson; Oscar L Lopez; Gregory Burke; Linda Fried; Lewis H Kuller; John Robbins; Russell Tracy; Nancy Woolard; Leslie Dunn; Richard Kronmal; Richard Nahin; Curt Furberg Journal: Contemp Clin Trials Date: 2006-04-19 Impact factor: 2.226
Authors: Shirley S Kishiyama; Marjorie J Leahy; Tracy A Zitzelberger; Robin Guariglia; Daniel P Zajdel; James F Calvert; Jeffrey A Kaye; Barry S Oken Journal: Altern Ther Health Med Date: 2005 May-Jun Impact factor: 1.305
Authors: Hiroko H Dodge; Yuriko Katsumata; Hidemi Todoriki; Shoutoku Yasura; D Craig Willcox; Gene L Bowman; Bradley Willcox; Scott Leonard; Aaron Clemons; Barry S Oken; Jeffrey A Kaye; Maret G Traber Journal: J Gerontol A Biol Sci Med Sci Date: 2010-07-19 Impact factor: 6.053
Authors: B Scherrer; S Andrieu; P J Ousset; G Berrut; J F Dartigues; B Dubois; F Pasquier; F Piette; P Robert; J Touchon; P Garnier; H Mathiex-Fortunet; B Vellas Journal: J Nutr Health Aging Date: 2015-12 Impact factor: 4.075
Authors: Stefan Weinmann; Stephanie Roll; Christoph Schwarzbach; Christoph Vauth; Stefan N Willich Journal: BMC Geriatr Date: 2010-03-17 Impact factor: 3.921
Authors: Debra L Barton; Kelli Burger; Paul J Novotny; Tom R Fitch; Sadhna Kohli; Gamini Soori; Mary Beth Wilwerding; Jeff A Sloan; Lisa A Kottschade; Kendrith M Rowland; Shaker R Dakhil; Daniel A Nikcevich; Charles L Loprinzi Journal: Support Care Cancer Date: 2012-11-13 Impact factor: 3.603