O3-04-03: A 240-mg once-daily formulation of Ginkgo Biloba extract EGb 761® is effective in both Alzheimer's disease and vascular dementia: Results from a randomized controlled trial

Background: Secondary analyses of a randomized controlled trial were performed to investigate whether treatment effects of a once-daily formulation of Ginkgo biloba extract EGb 761® differed by type of dementia. Methods: 410 patients ≥ 50 years of age diagnosed with mild to moderate dementia (Alzheimer's disease or vascular dementia) with neuropsychiatric features were enrolled and treated with a once-daily formulation of 240 mg of EGb 761® or placebo for a period of 24 weeks. Patients scored below 36 on the TE4D screening test for dementia and between 9 and 23 on the cross-culturally validated SKT cognitive test battery. Their total score on the Neuropsychiatric Inventory (NPI) was at least 5. Efficacy was assessed by the total scores of the SKT cognitive battery and the NPI (primary outcomes). The Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC), the Alzheimer's Disease Activities of Daily Living International Scale (ADL-IS), the Quality of Life Scale for People with Dementia (DEMQOL-Proxy), and the Verbal Fluency Test were secondary outcomes. Results: Of the 404 patients evaluable for efficacy, 333 patients were prospectively diagnosed with Alzheimer's disease (AD) and 71 with vascular dementia (VaD). Under EGb 761® treatment the SKT total score improved by -1.4 ± 2.8 points in both AD and VaD subgroups, whereas the AD and VaD patients on placebo deteriorated by +0.3 ± 2.7 points or remained unchanged, respectively (p < 0.01 and p < 0.05 for drug-placebo differences). The NPI total score improved by -2.9 ± 5.9 points in AD patients and by -4.5 ± 6.5 in VaD patients following EGb 761® treatment, whereas a deterioration by +0.2 ± 6.2 and a slight improvement by -1.3 ± 5.9 were observed in the corresponding sub-groups under placebo (p < 0.01 and p < 0.05 for drug-placebo differences). Significant drug-placebo differences were found for all secondary outcome variables with no major differences between AD and VaD subgroups, except for the DEMQOL-Proxy. Conclusions: EGb 761® distinctly improved cognitive functioning, non-cognitive symptoms and functional abilities in both AD and VaD, while the rates of adverse events in EGb 761® and placebo groups were essentially similar.