IngentaConnect Ginkgo biloba extract EGb 761, donepezil or both combined in the ...

Authors: Yancheva, S.¹; Ihl, R.²; Nikolova, G.¹; Panayotov, P.³; Schlaefke, S.⁴; Hoerr, R.⁴

Source: Aging and Mental Health, Volume 13, Number 2, March 2009 , pp. 183-190(8)

Publisher: Routledge, part of the Taylor & Francis Group

Abstract:

Objective: This randomised, double-blind exploratory trial was undertaken to compare treatment effects and tolerability of EGb 761®, donepezil and combined treatment in patients with AD and neuropsychiatric features. Method: We enrolled 96 outpatients, aged 50 years or above, who met the NINCDS/ADRDA criteria for probable AD, scored below 36 on the TE4D, a screening test for dementia, below 6 on the Clock-Drawing Test (CDT) and between 9 and 23 on the SKT, a cross-culturally validated cognitive test battery. They scored at least five on the 12-item Neuropsychiatric Inventory (NPI). EGb 761® (240 mg per day), donepezil (initially 5 mg, after 4 weeks 10 mg per day) or EGb 761® and donepezil combined (same doses) were administered for 22 weeks. Results: Changes from baseline to week 22 and response rates were similar for all three treatment groups with respect to all outcome measures (SKT, NPI, total score and activities-of-daily-living sub-score of the Gottfries-Bråne-Steen Scale, Hamilton Rating Scale for Depression, CDT and Verbal Fluency Test). An apparent tendency in favour of combination treatment warrants further scrutiny. Compared to donepezil mono-therapy, the adverse event rate was lower under EGb 761® treatment and even under the combination treatment. Conclusion: These exploratory findings helped to develop three hypotheses that will have to be proven in further studies: (1) there is no significant difference in the efficiency between EGb 761® and donepezil, (2) a combination therapy will be superior to a mono-therapy with one of both substances and (3) there will be less side effects under a combination therapy than under mono-therapy with donepezil.

Keywords: dementia; double-dummy technique; randomised controlled trial

Document Type: Research article

DOI: 10.1080/13607860902749057

Affiliations: 1: Hospital St. Naum, Sofia, Bulgaria 2: University of Duesseldorf, Duesseldorf, Germany,Alexian Hospital, Krefeld, Germany 3: Psychiatric Hospital, Rousse, Bulgaria 4: Dr Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany

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Ginkgo biloba extract EGb 761®, donepezil or both combined in the treatment of Alzheimer's disease with neuropsychiatric features: A randomised, double-blind, exploratory trial