Pharmacopsychiatry 2012; 45(02): 41-46
DOI: 10.1055/s-0031-1291217
Original Paper
© Georg Thieme Verlag KG Stuttgart · New York

Efficacy and Tolerability of a Once Daily Formulation of Ginkgo biloba Extract EGb 761® in Alzheimer’s Disease and Vascular Dementia: Results from a Randomised Controlled Trial

R. Ihl
1   Geriatric Psychiatry Centre, Maria-Hilf Hospital Krefeld, Krefeld, Germany
M. Tribanek
2   Clinical Research Department, Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany
N. Bachinskaya
3   Institute of Gerontology, Academy of Medical Sciences, Kiev, Ukraine
for the GOTADAY Study Group › Author Affiliations
Further Information

Publication History

received 29 November 2010
revised 09 July 2011

accepted 18 July 2011

Publication Date:
15 November 2011 (online)



A 24-week randomised controlled trial was conducted to assess the efficacy of a 240 mg once-daily preparation of Ginkgo biloba extract EGb 761® in 404 outpatients≥50 years diagnosed with mild to moderate dementia (SKT 9–23), Alzheimer’s disease (AD) or vascular dementia (VaD), with neuropsychiatric features (NPI total score≥5).


Separate analyses were performed for diagnostic subgroups (probable or possible AD; VaD).


333 patients were diagnosed with AD and 71 with VaD. EGb 761® treatment was superior to placebo with respect to the SKT total score (drug-placebo differences: 1.7 for AD, p<0.001, and 1.4 for VaD, p<0.05) and the NPI total score (drug-placebo differences: 3.1 for AD, p<0.001 and 3.2 for VaD, p<0.05). Significant drug-placebo differences were found for most secondary outcome variables with no major differences between AD and VaD subgroups. Rates of adverse events in EGb 761® and placebo groups were essentially similar.


EGb 761® improved cognitive functioning, neuropsychiatric symptoms and functional abilities in both types of dementia.

  • References

  • 1 IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen . Ginkgohaltige Präparate bei Alzheimer Demenz. Abschlussbericht. Auftrag A05-19B. Version 1.0. [Ginkgo in Alzheimer’s disease. IQWiG Reports. Commission No. A05-19B.] Cologne: IQWiG; 2008
  • 2 Kasper S, Schubert H. Ginkgo-Spezialextrakt EGb 761® in der Behandlung der Demenz: Evidenz für Wirksamkeit und Verträglichkeit. [Ginkgo biloba extract EGb 761® in the treatment of dementia: evidence of efficacy and tolerability]. Fortschr Neurol Psychiatr 2009; 77: 494-506
  • 3 Weinmann S, Roll S, Schwarzbach C et al. Effects of Ginkgo biloba in dementia: systematic review and meta-analysis. BMC Geriatrics 2010; 14 DOI: 10.1186/1471-2318-10-14.
  • 4 Wang BS, Wang H, Song YY et al. Effectiveness of standardized Ginkgo biloba extract on cognitive symptoms of dementia with a six-month treatment: A bivariate random effect meta-analysis. Pharmacopsychiatry 2010; 43: 86-91
  • 5 Kampkötter A, Pielarski T, Rohrig R et al. The Ginkgo biloba extract EGb 761® reduces stress sensitivity, ROS accumulation and expression of catalase and glutathione S-transferase 4 in Caenorhabditis elegans. Pharmacol Res 2007; 55: 139-147
  • 6 Eckert A, Keil U, Kressmann S et al. Effects of EGb 761® Ginkgo biloba extract on mitochondrial function and oxidative stress. Pharmacopsychiatry 2003; 36 (Suppl. 01) S15-S23
  • 7 Abdel-Kader R, Hauptmann S, Keil U et al. Stabilization of mitochondrial function by Ginkgo biloba extract (EGb 761®). Pharmacol Res 2007; 56: 493-502
  • 8 Költringer P, Langsteger W, Eber O. Dose-dependent hemorheological effects and microcirulatory modifications following intravenous administration of Ginkgo biloba special extract EGb 761. Clin Hemorheol 1995; 15: 649-656
  • 9 Wu Y, Wu Z, Butko P et al. Amyloid-ß-induced pathological behaviors are suppressed by Ginkgo biloba extract EGb 761® and ginkgolides in transgenic caenorhabditis elegans. J Neurosci 2006; 26: 13102-13113
  • 10 Bastianetto S, Ramassamy C, Doré S et al. The Ginkgo biloba extract (EGb 761®) protects hippocampal neurons against cell death induced by β-amyloid. Eur J Neurosci 2000; 12: 1882-1890
  • 11 Tchantchou F, Xu Y, Wu Y et al. EGb 761 enhances adult hippocampal neurogenesis and phosphorylation of CREB in transgenic mouse model of Alzheimer’s disease. FASEB J 2007; 21: 2400-2408
  • 12 Tchantchou F, Lacor PN, Cao Z et al. Stimulation of neurogenesis and synaptogenesis by bilobalide and quercetin via common final pathway in hippocampal neurons. J Alzheimers Dis 2009; 18: 787-798
  • 13 Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001; 23: 1296-1310
  • 14 Cals JW, Hopstaken RM, Le Doux PH et al. Dose timing and patient compliance with two antibiotic treatment regimens for lower respiratory tract infections in primary care. Int J Antimicrob Agents 2008; 31: 531-536
  • 15 DeJesus E, Ruane P, McDonald C et al. Impact of switching virologically suppressed, HIV-1-infected patients from twice-daily fixed-dose zidovudine/lamivudine to once-daily fixed-dose tenofovir disoproxil fumarate/emtricitabine. HIV Clin Trials 2008; 9: 103-114
  • 16 Ihl R, Bachinskaya N, Korczyn A et al. Safety of a once-daily formulation of Ginkgo biloba extract EGb 761® in Dementia with Neuropsychiatric Features. A randomized controlled trial. Int J Geriatr Psychiatry, in press; DOI: 10.1002/gps.2662.
  • 17 McKhann G, Drachman D, Folstein M et al. Clinical diagnosis of Alzheimer’s disease: Report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer’s Disease. Neurology 1984; 34: 939-944
  • 18 Román GC, Tatemichi TK, Erkinjuntti T et al. Vascular dementia: diagnostic criteria for research studies. Report of the NINDS-AIREN International Workshop. Neurology 1993; 43: 250-260
  • 19 Ihl R, Biesenbach A, Brieber S et al. A head-to-head comparison of the sensitivity of two screening tests for dementia. Mini-mental-state-examination (MMSE) and the test for the early detection of dementia with discrimination from depression (TE4D). Psychogeriatria Polska 2005; 2: 263-271
  • 20 Kim YS, Nibbelink DW, Overall JE. Factor structure and scoring of the SKT test battery. J Clin Psychol 1993; 49: 61-71
  • 21 Cummings JL. The neuropsychiatric inventory: Assessing psychopathology in dementia patients. Neurology 1997; 48 (Suppl. 06) S10-S16
  • 22 Erzigkeit H. SKT Manual. Castrop-Rauxel: Geromed; 1992
  • 23 Lehfeld H, Rudinger G, Rietz C et al. Evidence of the cross-cultural stability of the factor structure of the SKT short test for assessing deficits of memory and attention. Int Psychogeriatr 1997; 9: 139-153
  • 24 Schneider LS, Olin JT, Doody RS et al. Validity and reliability of the alzheimer’s disease cooperative study-clinical global impression of change. Alzheimer Dis Assoc Disord 1997; 11 (Suppl. 02) S22-S32
  • 25 Reisberg B, Finkel S, Overall J et al. The Alzheimer’s disease activities of daily living international scale (ADL-IS). Int Psychogeriatr 2001; 13: 163-181
  • 26 Smith SC, Lamping DL, Banerjee S et al. Measurement of health-related quality of life for people with dementia: development of a new instrument (DEMQOL) and an evaluation of current methodology. Health Technol Assess 2005; 9 No. 10
  • 27 Mahoney R, Johnston K, Katona C et al. The TE4D-Cog: a new test for detecting early dementia in English-speaking populations. Int J Geriatr Psychiatry 2005; 20: 1172-1179
  • 28 Ihl R, Grass-Kapanke B, Jänner M et al. Neuropsychometric tests in cross sectional and longitudinal studies – a regression analysis of ADAS-Cog, SKT and MMSE. Pharmacopsychiatry 1999; 32: 248-254
  • 29 Mega MS, Masterman DM, O’Connor SM et al. The spectrum of behavioral responses to cholinesterase inhibitor therapy in Alzheimer disease. Arch Neurol 1999; 56: 1388-1393
  • 30 Kanowski S, Herrmann WM, Stephan K et al. Proof of efficacy of the Ginkgo biloba extract EGb 761 in outpatients suffering from mild to moderate primary degenerative dementia of the Alzheimer type or multi-infarct dementia. Pharmacopsychiatry 1996; 29: 47-56
  • 31 Napryeyenko O, Sonnik G, Tartakovsky I. Efficacy and tolerability of Ginkgo biloba extract EGb 761® by type of dementia: analyses of a randomised controlled trial. J Neurol Sci 2009; 283: 224-229
  • 32 Schneider LS, DeKosky ST, Farlow MR et al. A randomized, double-blind, placebo-controlled trial of two doses of Ginkgo biloba extract in dementia of the Alzheimer’s type. Curr Alzheimer Res 2005; 2: 541-551
  • 33 Holmes C, Cairns N, Lantos P et al. Validity of current clinical criteria for Alzheimer’s disease, vascular dementia and dementia with Lewy bodies. Br J Psychiatry 1999; 174: 45-50
  • 34 Korczyn AD. Mixed dementia – the most common cause of dementia. Ann NY Acad Sci 2002; 977: 129-134
  • 35 Hachinski V. Shifts in thinking about dementia. JAMA 2008; 300: 2172-2173
  • 36 Schneider JA, Arvanitakis Z, Bang W et al. Mixed brain pathologies account for most dementia cases in community-dwelling older persons. Neurology 2007; 69: 2197-2204
  • 37 Matthews FE, Brayne C, Lowe J et al. Epidemiological pathology of dementia: attributable-risks at death in the Medical Research Council cognitive function and ageing study. PLoS Med 2009; 6 e1000180