Alleviating neuropsychiatric symptoms in dementia: the effects of Ginkgo biloba extract EGb 761®. Findings from a randomized controlled trial

Abstract

Natalia Bachinskaya1, Robert Hoerr2, Ralf Ihl3For the GOTADAY Study Group1Institute of Gerontology, Academy of Medical Sciences, Kiev, Ukraine; 2Clinical Research Department, Dr Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany; 3Geriatric Psychiatry Center, Maria-Hilf Hospital Krefeld, Krefeld, GermanyPurpose: To examine the effects of Ginkgo biloba extract EGb 761® on neuropsychiatric symptoms of dementia.Patients and methods: Randomized, controlled, double-blind, multicenter clinical trial involving 410 outpatients with mild to moderate dementia (Alzheimer’s disease with or without cerebrovascular disease, vascular dementia), scoring at least 5 on the Neuropsychiatric Inventory (NPI), with at least one item score of 3 or more. Total scores on the SKT cognitive test battery (Erzigkeit’s short syndrome test) were between 9 and 23. After random allocation, the patients took 240 mg of EGb 761® or placebo once daily for a period of 24 weeks. Changes from baseline to week 24 in the NPI composite and in the SKT total score were the primary outcomes. The NPI distress score was chosen as a secondary outcome measure to evaluate caregivers’ distress.Results: The NPI composite score improved by -3.2 (95% confidence interval -4.0 to -2.3) in patients taking EGb 761® (n = 202), but did not change (-0.9; 0.9) in those receiving placebo (n = 202), which resulted in a statistically significant difference in favor of EGb 761® (P < 0.001). Treatment with EGb 761® was significantly superior to placebo for the symptoms apathy/indifference, sleep/night-time behavior, irritability/lability, depression/dysphoria, and aberrant motor behavior. Caregivers’ distress evaluation revealed similar baseline pattern and improvements.Conclusion: Treatment with EGb 761®, at a once-daily dose of 240 mg, was safe, effectively alleviated behavioral and neuropsychiatric symptoms in patients with mild to moderate dementia, and improved the wellbeing of their caregivers.Keywords: Alzheimer's disease, vascular dementia, patients, caregivers, Ginkgo biloba, EGb 761®