Director of Geriatric Psychiatry Centre.
Efficacy and safety of a once-daily formulation of Ginkgo biloba extract EGb 761 in dementia with neuropsychiatric features: a randomized controlled trial
Article first published online: 7 DEC 2010
Copyright © 2010 John Wiley & Sons, Ltd.
International Journal of Geriatric Psychiatry
Volume 26, Issue 11, pages 1186–1194, November 2011
How to Cite
Ihl, R., Bachinskaya, N., Korczyn, A. D., Vakhapova, V., Tribanek, M., Hoerr, R., Napryeyenko, O. (2011), Efficacy and safety of a once-daily formulation of Ginkgo biloba extract EGb 761 in dementia with neuropsychiatric features: a randomized controlled trial. Int. J. Geriat. Psychiatry, 26: 1186–1194. doi: 10.1002/gps.2662
- Issue published online: 17 OCT 2011
- Article first published online: 7 DEC 2010
- Manuscript Accepted: 6 OCT 2010
- Manuscript Received: 13 APR 2010
- Willmar Schwabe GmbH & Co. KG Pharmaceuticals, Karlsruhe, Germany
- Alzheimer's disease;
- vascular dementia;
- Ginkgo biloba;
- EGb 761;
- randomized controlled trial
To test the efficacy and safety of a once-daily formulation of EGb 761 in the treatment of patients with dementia with neuropsychiatric features.
Multi-centre trial of 410 outpatients with mild to moderate dementia (Alzheimer's disease, vascular dementia or mixed form) scoring between 9 and 23 on the SKT cognitive test battery, at least five on the Neuropsychiatric Inventory (NPI) and three or higher in at least one item of the NPI. Patients were randomly allocated to double-blind treatment with 240 mg of EGb 761 or placebo once daily for 24 weeks. Primary outcomes were the changes from baseline in the SKT total score and the NPI total score. The Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC), Activities of Daily Living International Scale (ADL-IS), NPI distress score, DEMQOL-Proxy quality-of-life scale and Verbal Fluency Test were secondary outcomes.
At endpoint, patients treated with EGb 761 (n = 202) improved by −1.4 (95% confidence interval −1.8; −1.0) points on the SKT and by −3.2 (−4.0; −2.3) on the NPI total score, whereas those receiving placebo (n = 202) deteriorated by +0.3 (−0.1; 0.7) on the SKT and did not change on the NPI total score (−0.9; 0.9). Both drug-placebo comparisons were significant at p < 0.001. EGb 761 was significantly superior to placebo with respect to all secondary outcome measures. Adverse event rates were similar for both treatment groups.
EGb 761, 240 mg once-daily, was found significantly superior to placebo in the treatment of patients with dementia with neuropsychiatric symptoms. Copyright © 2010 John Wiley & Sons, Ltd.