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

Geriatric Psychiatry Centre, Maria-Hilf Hospital Krefeld, Krefeld, Germany.
Pharmacopsychiatry (Impact Factor: 1.85). 11/2011; 45(2):41-6. DOI: 10.1055/s-0031-1291217
Source: PubMed


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.

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    • "These results imply that Gb drugs containing the recommended daily dose of 240 mg in a single tablet might be favorable for patients’ persistence - although according to the current label the tablet should be split and one half taken twice a day [22], i.e. the dosage interval thus remains unaltered compared to twice daily dosing of Gb products with 120 mg dosage strength. Nevertheless, we cannot exclude that patients may use the 240 mg product once daily, as this may be more practicable in real-life settings for patients with cognitive impairment and their care-givers [23]. A simpler and less frequent doses regime may increase patients’ adherence [16,17]. "
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    ABSTRACT: Ginkgo biloba drugs (Gb) are reimbursed within the German statutory health insurance (SHI) scheme for treatment of dementia. In 2008, a novel Gb product containing 240 mg Ginkgo extract EGb761(R) per tablet was introduced aiming to facilitate medication use by incorporating the recommended daily dose in one single tablet. The aim of this study was to evaluate the relationship between dosage strength and persistence in a representative population of patients treated with Gb. Retrospective cohort study in ambulatory drug claims database within the German SHI system. Persistence was defined as continuous treatment with an allowable gap of 20% between refills. Multivariate regression models were conducted to identify variables associated with persistence. Among 13,810 patients initiating treatment with Gb in 2008, 430 (3.1%) received a dosage strength of 240 mg, 7,070 (51.2%) a dosage strength of 120 mg and 6,310 (45.7%) dosage strengths containing less than 120 mg Gb per tablet. After 6 months, persistence was highest for patients treated with the 240 mg dosage form (22.8% of patients), although persistence was low in general (5.7% and 0% of patients treated with 120 mg and less than 120 mg, respectively). Risk for non-persistence was reduced in patients receiving 240 mg products compared to 120 mg (HR = 0.63; 95%CI 0.57 -- 0.70). Patients initially treated with Gb 240 mg were more persistent compared to those receiving lower dosage strengths. Nevertheless, persistence with Gb therapy is generally low and should be improved in order to better realize therapeutic effects.
    Full-text · Article · Oct 2013 · BMC Complementary and Alternative Medicine
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    • "The clinical efficacy of Ginkgo biloba extracts, including EGb 761, was observed (modest improvements in cognitive function) following administration to AD and non-AD patients in various studies [15,16]. In a 24-week randomised controlled trial, using 240 mg once-daily preparation of Ginkgo biloba extract EGb 761 in 404 outpatients, EGb 761 can improve cognitive functioning, neuropsychiatric symptoms and functional abilities in AD and VaD [17]. However, in Ginkgo Evaluation of Memory (GEM) study, a randomized, double-blind, placebo-controlled clinical trial of 3069 community-dwelling participants aged 72 to 96 years, with a median follow-up of 6.1 years, Snitz et al. reported that the use of G. biloba, 120 mg twice daily, did not result in less cognitive decline in older adults with normal cognition or with mild cognitive impairment [18], Which results has the negative study and it different from the results studied before. "
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    ABSTRACT: Alzheimer's disease (AD) is an age-related neurodegenerative disorder, characterized clinically by insidious onset of memory and cognition impairment, emergence of psychiatric symptoms and behavioral disorder, and impairment of activities of daily living (ADL). Traditional Chinese medicine (TCM) is practiced in the Chinese health care system for more than 2,000 years. In recent years, scientists have isolated many novel compounds from herbs, some of which improve dementia with fewer side effects than conventional drugs and are regarded as potential anti-AD drugs. In this review, we summarize the latest research progress on TCM showing their possible role of treatment of AD and other demented diseases and possible pharmacological actions.
    Full-text · Article · Feb 2013 · Translational Neurodegeneration
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    ABSTRACT: The global trend of the phenomenon of population ageing has dramatic consequences on public health and the incidence of neurodegenerative diseases. Physiological changes that occur during normal ageing of the brain may exacerbate and initiate pathological processes that may lead to neurodegenerative disorders, especially Alzheimer's disease (AD). Hence, the risk of AD rises exponentially with age. While there is no cure currently available, sufficient intake of certain micronutrients and secondary plant metabolites may prevent disease onset. Polyphenols are highly abundant in the human diet, and several experimental and epidemiological evidences indicate that these secondary plant products have beneficial effects on AD risks. This study reviews current knowledge on the potential of polyphenols and selected polyphenol-rich diets on memory and cognition in human subjects, focusing on recent data showing in vivo efficacy of polyphenols in preventing neurodegenerative events during brain ageing and in dementia. Concentrations of polyphenols in animal brains following oral administration have been consistently reported to be very low, thus eliciting controversial discussion on their neuroprotective effects and potential mechanisms. Whether polyphenols exert any direct antioxidant effects in the brain or rather act by evoking alterations in regulatory systems of the brain or even the body periphery is still unclear. To understand the mechanisms behind the protective abilities of polyphenol-rich foods, an overall understanding of the biotransformation of polyphenols and identification of the various metabolites arising in the human body is also urgently needed.
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