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

Neuropsychiatric symptoms in dementia and the effects of Ginkgo biloba extract EGb 761® treatment: additional results from a 24-week randomized, placebo-controlled trial 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