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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: 2.17). 11/2011; 45(2):41-6. DOI: 10.1055/s-0031-1291217
Source: PubMed

ABSTRACT 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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    • "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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