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
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.
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A Gingko biloba extract and donepezil have comparable efficacy in Alzheimer's disease patients with associated neuropsychiatric problems.
“A randomized, double-blind exploratory trial reported comparable efficacy of a Gingko biloba extract and donepezil in AD patients with associated neuropsychiatric problems.”
From Indian Medicinal Herbs and Formulations for Alzheimer’s Disease, from Traditional Knowledge to Scientific Assessment (2020) · cites this paper as [49]
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“The combination was reported to be superior to donepezil monotherapy in terms of both safety and efficacy [49].”
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- Authors
- Yancheva, S., Ihl, R., Nikolova, G., Panayotov, P., Schlaefke, S., Hoerr, R., & for the GINDON Study Group
- Affiliations
- a Hospital St. Naum , Sofia, Bulgaria
- Heinrich Heine University Düsseldorf (DE)
- Kharkiv Regional Clinical Psychiatric Hospital No 3 (UA)
- Dr Willmar Schwabe (Germany) (DE)
- Corresponding author
- Hoerr, R.
- Venue
- Aging & Mental Health
- Publisher
- Informa UK Limited
- Published
- 2009-03-01
- Volume
- 13
- Issue
- 2
- Pages
- 183-190
- ISSN
- 1360-7863 (ISSN-L)
- 1364-6915
- OpenAlex
- W1980059384
- Cited by
- 127
- References
- 28
- Citations by year
- 2026: 4 · 2025: 6 · 2024: 7 · 2023: 8 · 2022: 8 · 2021: 9 · 2020: 9 · 2019: 6 · 2018: 6 · 2017: 9 · 2016: 2 · 2015: 9 · 2014: 5 · 2013: 13 · 2012: 7
- FWCI
- 20.16
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Aging & Mental Health (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Complementary and alternative medicine › Ginkgo biloba and Cashew Applications
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Keywords
- Alzheimer's disease, Ginkgo biloba extract EGb 761, donepezil, combination therapy, neuropsychiatric symptoms, cholinesterase inhibitors, cognitive function, activities of daily living, adverse events, tolerability
- MeSH terms
- Donepezil, Ginkgo Extract, Aged, Aged, 80 and over, Alzheimer Disease, Bulgaria, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Indans, Male, Middle Aged, Piperidines, Plant Extracts, Outcome Assessment, Health Care, Nootropic Agents, Ginkgo biloba
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