Open Access Journal of Clinical Trials (Jan 2016)
Neuropsychiatric symptoms in dementia and the effects of Ginkgo biloba extract EGb 761® treatment: additional results from a 24-week randomized, placebo-controlled trial
Abstract
Anatol Nacu,1 Robert Hoerr21Clinical Psychiatry Hospital, State University of Medicine and Pharmacy Nicolae Testemiţanu, Chişinău, Republic of Moldova; 2Clinical Research Department, Dr Willmar Schwabe GmbH and Co. KG, Karlsruhe, GermanyBackground: In randomized controlled trials, Ginkgo biloba extract EGb 761® has proven to be effective in the treatment of dementia.Trial registration: Clinical-Trials.ru 390378.Patients and methods: In pre-specified descriptive analyses of data from a recently published trial, we examined the effects of EGb 761® on specific neuropsychiatric symptoms. In a 24-week, double-blind, multi-center trial, 410 outpatients with mild to moderate dementia and clinically significant neuropsychiatric symptoms were enrolled and randomized to receive 240 mg/day EGb 761® or placebo. The Neuropsychiatric Inventory composite score and the SKT short cognitive performance test were prospectively defined as co-primary outcomes; caregiver distress scores and single item scores were prospectively defined as secondary outcomes.Results: Post-baseline efficacy data were available for 402 patients included in the full analysis set. Neuropsychiatric Inventory composite and caregiver distress scores improved significantly more under EGb 761® treatment than under placebo (P<0.001). Composite and caregiver distress scores of anxiety, apathy, and disturbances of sleep and nighttime behavior, as well as caregiver distress scores of depression and aberrant motor behavior, were improved most markedly by EGb 761® (P<0.05 vs placebo).Conclusion: EGb 761® at daily doses of 240 mg alleviated neuropsychiatric symptoms of dementia and reduced related caregiver distress.Keywords: dementia, neuropsychiatric symptoms, Ginkgo biloba, EGb 761®, randomized controlled trial
