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Ginkgo Extract Compares Favorably to Placebo in Effects on Elevated Neuropsychiatric Symptom Scores
Date 02-28-2011
HC# 101055-419
Ginkgo (Ginkgo biloba)
Neuropsychiatric Symptoms
Re:  Ginkgo Extract Compares Favorably to Placebo in Effects on Elevated Neuropsychiatric Symptom Scores

Ihl R, Tribanek M, Bachinskaya N. Baseline neuropsychiatric symptoms are effect modifiers in Ginkgo biloba extract (EGb 761®) treatment of dementia with neuropsychiatric features. Retrospective data analyses of a randomized controlled trial. J Neurol Sci. December 15, 2010;299(1-2):184-187.

Neuropsychiatric symptoms (i.e., depression, apathy, and anxiety) commonly occur in people with dementia, Alzheimer’s disease (AD), and vascular dementia. The symptoms can occur in people with mild cognitive impairment and may predict future progression to dementia. Neuropsychiatric symptoms adversely impact quality of life. One study of ginkgo (Ginkgo biloba) extract EGb 761® (Dr. Willmar Schwabe GmbH & Co., KG Pharmaceuticals; Karlsruhe, Germany) for the treatment of AD associated dementia revealed that EGb 761 may be more effective in patients with at least mild neuropsychiatric symptoms than in those without neuropsychiatric symptoms. Hence, the purpose of this study was to retrospectively analyze data from the most recent ginkgo clinical trial for dementia to determine whether treatment effects correlate with neuropsychiatric symptom burden at baseline.

This was a retrospective analysis of a randomized, placebo-controlled, double-blind, multi-center, clinical trial of EGb 761 in patients (n = 410, ≥ 50 years) with diagnosed mild to moderate dementia (AD, vascular dementia, or AD with cerebrovascular disease) associated with neuropsychiatric symptoms. Patients were randomized to receive 1 tablet per day of 240 mg EGb 761 or placebo for 24 weeks. EGb 761 is a dry extract from ginkgo leaves (drug-extract ratio 35-67:1), adjusted to 22.0-27.0% ginkgo flavonoids and 5.0-7.0% terpene lactones consisting of 2.8-3.4% ginkgolides A, B, C and 2.6-3.2% bilobalide, with a content of ginkgolic acids below 5 ppm. For the primary analysis (not the focus of this study), efficacy was evaluated via a battery of tests at 12 and 24 weeks post-baseline. For the retrospective analysis, patients were divided into 3 groups according to their NeuroPsychiatric Inventory (NPI) test score at baseline (< 12, 12-18, or > 18).

For patients treated with EGb 761, cognitive and non-cognitive changes from baseline to week 24 were similar for high and low NPI subgroups. In contrast, in the placebo group, patients with high baseline NPI composite scores had significantly worse outcomes in cognitive and functional measures than those with low NPI baseline scores. The correlation between baseline NPI composite score and changes from baseline in cognitive and non-cognitive outcome measures for the EGb 761 group were weak to modest and mainly non-significant. In contrast, in the placebo group, higher NPI baseline scores were significantly associated with faster deterioration in cognitive abilities (SKT test battery, P = 0.048), the cognitive part of the Test for Early Detection of Dementia with Discrimination from Depression (TE4D, P = 0.004), and activities of daily living (AD Activities-of-Daily-Living International Scale [ADL-IS], P = 0.009).

This indicates that, in contrast to placebo, a higher burden of neuropsychiatric symptoms does not diminish EGb 761 treatment effects. EGb 761 was safe and well-tolerated.

The findings are in agreement with other reports that neuropsychiatric symptoms are associated with a more rapid progression of dementia. Nonetheless, the results demonstrate that EGb 761 was effective irrespective of baseline neuropsychiatric symptom severity. A strength of this study is that it included patients with a wide range of diagnoses, which is closer to a real-world situation than a clinical trial that has more conservative inclusion criteria.

—Heather S. Oliff, PhD