Ginkgo biloba special extract in dementia with neuropsychiatric features. A randomised, placebo-controlled, double-blind clinical trial.

摘要

BACKGROUND: In previous trials of the Ginkgo biloba special extract EGb 761 improvements in cognitive functioning and behavioural symptoms were found in patients with aging-associated cognitive impairment or dementia. This trial was undertaken to assess the efficacy of EGb 761 in mild to moderate dementia with neuropsychiatric features. METHODS: Double-blind trial including 400 patients aged 50 years or above with Alzheimer's disease (AD) or vascular dementia (VaD), randomized to receive EGb 761 or placebo for 22 weeks. Patients scored below 36 on the Test for the Early Detection of Dementia with Discrimination from Depression (TE4D), between 9 and 23 on the SKT test battery and at least 5 on the Neuropsychiatric Inventory (NPI). RESULTS: There was a mean -3.2-point improvement in the SKT upon EGb 761 treatment and an average deterioration by +1.3 points on placebo (p < 0.001, two-sided, ANOVA). EGb 761 was significantly superior to placebo on all secondary outcome measures, including the NPI and an activities-of-daily-living scale. Treatment results were essentially similar for AD and VaD subgroups. The drug was well tolerated; adverse events were no more frequent under drug than under placebo treatment. CONCLUSION: The data add further evidence on the safety and efficacy of EGb 761 in the treatment of cognitive and non-cognitive symptoms of dementia.