A multi-centre, double-blind, randomised, placebo-controlled, 24-week trial with 410 outpatients was conducted to demonstrate efficacy and safety of a 240 mg once-daily formulation of Ginkgo biloba extract EGb 761(®) in patients with mild to moderate dementia (Alzheimer's disease or vascular dementia) associated with neuropsychiatric symptoms. Patients scored 9 to 23 on the SKT cognitive battery, at least 6 on the Neuropsychiatric Inventory (NPI), with at least one of four key items rated at least 4. Primary outcomes were the changes from baseline to week 24 in the SKT and NPI total scores. The ADCS Clinical Global Impression of Change (ADCS-CGIC), Verbal Fluency Test, Activities of Daily Living International Scale (ADL-IS), DEMQOL-Proxy quality-of-life scale and 11-point box scales for tinnitus and dizziness were secondary outcome measures. Patients treated with EGb 761(®) (n = 200) improved by 2.2 ± 3.5 points (mean ± sd) on the SKT total score, whereas those receiving placebo (n = 202) changed only slightly by 0.3 ± 3.7 points. The NPI composite score improved by 4.6 ± 7.1 in the EGb 761(®)-treated group and by 2.1 ± 6.5 in the placebo group. Both drug-placebo comparisons were significant at p < 0.001. Patients treated with EGb 761(®) also showed a more favourable course in most of the secondary efficacy variables. In conclusion, treatment with EGb 761(®) at a once-daily dose of 240 mg was safe and resulted in a significant and clinically relevant improvement in cognition, psychopathology, functional measures and quality of life of patients and caregivers.
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