Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.
Am J Alzheimers Dis Other Demen. 2010 Sep;25(6):483-9. doi: 10.1177/1533317510372923. Epub 2010 Jun 17.
The aim of this 12-week, open-label study was to determine the safety and efficacy of donepezil in participants with Alzheimer's disease (AD) residing in assisted living facilities (ALFs). Participants received 5 mg donepezil daily for 6 weeks followed by 10 mg daily for 6 weeks. Primary and secondary outcomes were change from baseline in Mini-Mental State Examination (MMSE) and Neuropsychiatric Inventory 8 (NPI-8) scores, respectively. Safety was assessed by adverse events (AEs) and laboratory tests. Of the 97 participants, 76 completed the study. Mean MMSE score (18.7 at baseline) improved 1.8 points (P < .0001) at study end. Total NPI-8 score improved 1.8 points (P = .043). The most frequent AEs were nausea and diarrhea. Donepezil improved cognition and behavior and was safe and well tolerated. The results suggest a need for proactive screening and diagnosis of AD and support the value of treatment and use of donepezil in participants residing in ALFs.
这项为期 12 周、开放性标签的研究旨在确定多奈哌齐在居住在辅助生活设施(ALF)中的阿尔茨海默病(AD)患者中的安全性和疗效。参与者接受每日 5 毫克多奈哌齐治疗 6 周,然后每日 10 毫克治疗 6 周。主要和次要结局分别为从基线到迷你精神状态检查(MMSE)和神经精神问卷 8(NPI-8)评分的变化。安全性通过不良事件(AE)和实验室检查来评估。在 97 名参与者中,有 76 名完成了研究。平均 MMSE 评分(基线时为 18.7)在研究结束时提高了 1.8 分(P<.0001)。总 NPI-8 评分提高了 1.8 分(P=.043)。最常见的不良反应是恶心和腹泻。多奈哌齐改善了认知和行为,且安全且耐受良好。结果表明,需要积极主动地筛查和诊断 AD,并支持对居住在 ALF 中的参与者进行治疗和使用多奈哌齐。