Alleviating neuropsychiatric symptoms in dementia: the effects of Ginkgo biloba extract EGb 761. Findings from a randomized controlled trial

Neuropsychiatric Disease and Treatment, 04/22/2011

Bachinskaya N et al. – Treatment with EGb 761, at a once–daily dose of 240 mg, was safe, effectively alleviated behavioral and neuropsychiatric symptoms in patients with mild to moderate dementia, and improved the wellbeing of their caregivers.

Methods

  • Randomized, controlled, double-blind, multicenter clinical trial involving 410 outpatients with mild to moderate dementia (Alzheimer’s disease with or without cerebrovascular disease, vascular dementia), scoring at least 5 on the Neuropsychiatric Inventory (NPI), with at least one item score of 3 or more.
  • Total scores on the SKT cognitive test battery (Erzigkeit’s short syndrome test) were between 9 and 23.
  • After random allocation, the patients took 240 mg of EGb 761 or placebo once daily for a period of 24 weeks.
  • Changes from baseline to week 24 in the NPI composite and in the SKT total score were the primary outcomes.
  • NPI distress score was chosen as a secondary outcome measure to evaluate caregivers’ distress.

Results

  • NPI composite score improved by -3.2 (95% confidence interval -4.0 to -2.3) in patients taking EGb 761 (n = 202), but did not change (-0.9; 0.9) in those receiving placebo (n = 202), which resulted in a statistically significant difference in favor of EGb 761 (P < 0.001).
  • Treatment with EGb 761 was significantly superior to placebo for the symptoms apathy/indifference, sleep/night-time behavior, irritability/lability, depression/dysphoria, and aberrant motor behavior.
  • Caregivers’ distress evaluation revealed similar baseline pattern and improvements.

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