Abstract

Ginkgo biloba extract EGb 761 ® improved neuropsychiatric symptoms (NPS) in patients with dementia in a series of trials. To explore the effects of EGb 761 ® on NPS in patients with mild cognitive impairment (MCI). A randomized, placebo-controlled, double-blind, 24-week, multi-center trial was conducted, including 160 patients with MCI who scored at least 6 on the 12-item Neuropsychiatric Inventory (NPI). Effects on NPS were assessed using the NPI, the state sub-score of the State-Trait Anxiety Inventory (STAI-X1) and the Geriatric Depression Scale (GDS). Further outcome measures were the Trail-Making Test (TMT, Forms A and B) and global ratings of change. Descriptive statistical analyses followed the intention-to-treat principle. The NPI composite score decreased by 7.0 ± 4.5 (mean, standard deviation) points in the EGb 761 ® -treated group and by 5.5 ± 5.2 points in the placebo group (p = 0.001). Improvement by at least 4 points was found in 78.8% of patients treated with EGb 761 ® and in 55.7% of those receiving placebo (p = 0.002). Significant superiority of EGb 761 ® over placebo was also found for the STAI-X1 score, the informants' global impression of change and both TMT scores. There were statistical trends favoring EGb 761 ® in the GDS and the patients' global impression of change. Adverse events were reported by 37 patients taking EGb 761 ® and 36 patients receiving placebo; there were no serious adverse events. EGb 761 ® improved NPS and cognitive performance in patients with MCI. The drug was safe and well tolerated.

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