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

Introduction: 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 (R) 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). Methods: Separate analyses were performed for diagnostic subgroups (probable or possible AD; VaD). Results: 333 patients were diagnosed with AD and 71 with VaD. EGb 761 (R) 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 (R) and placebo groups were essentially similar. Conclusion: EGb 761 (R) improved cognitive functioning, neuropsychiatric symptoms and functional abilities in both types of dementia.