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Ginkgo biloba extract EGb 761(R), donepezil or both combined in the treatment of Alzheimer’s disease with neuropsychiatric features: a randomised, double-blind, exploratory trial

Authors

Yancheva, S., Ihl, R., Nikolova, G., Panayotov, P., Schlaefke, S., Hoerr, R.

Journal

Aging & Mental Health, Volume: 13, No.: 2, Pages.: 183-190

Year of Publication

2009

Abstract

Objective: This randomised, double-blind exploratory trial was undertaken to compare treatment effects and tolerability of EGb 761(R), 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(R) (240 mg per day), donepezil (initially 5 mg, after 4 weeks 10 mg per day) or EGb 761(R) 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(R) 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(R) 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.;

Bibtex Citation

@article{Yancheva_2009, doi = {10.1080/13607860902749057}, url = {http://dx.doi.org/10.1080/13607860902749057}, year = 2009, month = {mar}, publisher = {Informa {UK} Limited}, volume = {13}, number = {2}, pages = {183--190}, author = {S. Yancheva and R. Ihl and G. Nikolova and P. Panayotov and S. Schlaefke and R. Hoerr and for the GINDON Study Group}, title = { Ginkgo biloba extract {EGb} 761{textregistered}, donepezil or both combined in the treatment of Alzheimer{textquotesingle}s disease with neuropsychiatric features: A randomised, double-blind, exploratory trial }, journal = {Aging {&} Mental Health} }

Keywords

administration & dosage, aged, aged, 80 and over, alzheimer disease, biloba, bulgaria, donezepil, double-blind method, drug therapy, drug therapy combination, extract, female, ginkgo, ginkgo biloba, humans, indans, male, middle aged, nootropic agents, outcome assessment (health care), pharmacology, physiopathology, piperidines, plant extracts, psychology, therapeutic use

Countries of Study

Bulgaria

Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Behaviour, Cognition

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime, Herbal remedies, vitamins, dietary supplements