Background: An effective hypnotic drug with a low risk of adverse reactions is required for Alzheimer’s disease (AD) patients, because the therapeutic interventions to improve sleep quality may help alleviate some symptoms of AD including cognitive function. Objective: The aim of this study was to investigate the efficacy and safety of Yokukansan in sleep disturbances in patients with AD and other dementia. Design: An open-label trial. Setting: Two sites consist of university and hospital in Japan. Participants: Thirteen patients (7 men and 6 women, average age = 76.0 ± 7.2 (mean ± SD) years old) including 12 AD and 1 frontotemporal dementia. Intervention: Treatment with Yokukansan (5–7.5 g/day) was given for 8 weeks. Measurements: The primary outcome measure was the Sleep Disorder Inventory (SDI) based on the Neuropsychiatric Inventory, an instrument developed by the Alzheimer’s Disease Cooperative Study. Secondary outcome measures included the objective actigraphic evaluations, Neuropsychiatric Inventory-Questionnaire (NPI-Q), MINI-Mental State Examination (MMSE). These assessments were evaluated at baseline, and weeks 4 and 8. Results: After 4 and 8 weeks treatment with Yokukansan, significant improvements were observed in the SDI total score, caregivers’ distress score, and NPI-Q total score. In actigraph data, wake after sleep onset (WASO) time (min), was significantly improved. The MMSE score did not change during the treatment. No serious adverse events were caused by YKS. Conclusion: The present results suggest that Yokukansan is safe and beneficial in the treatment of sleep disturbances and that it can possibly reduce the burden of care of demented patients.
The clinical meaningfulness of ADAS-Cog changes in Alzheimer's disease patients treated with donepezil in an open-label trial