Department of Neuropsychiatry, Faculty of Medicine, Kagawa University, Kita-gun, Japan.
Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Kobe, Japan.
J Alzheimers Dis. 2023;94(2):685-693. doi: 10.3233/JAD-230387.
In Japan, only oral formulation of donepezil hydrochloride is approved for the treatment of Alzheimer's disease.
To evaluate safety and efficacy of a donepezil patch 27.5 mg application for 52 weeks in patients with mild-to-moderate Alzheimer's disease; and to evaluate safety on switching from donepezil hydrochloride tablets.
This 28-week, open-label study (jRCT2080224517) is an extension of a 24-week double-blind (donepezil patch 27.5 mg versus donepezil hydrochloride tablet 5 mg) noninferiority study. The patch group (continuation group) continued administration of the patch and the tablet group (switch group) switched to the patch in this study.
A total of 301 patients participated (156 patients continued using patches; 145 patients switched). Both groups showed similar course on the Alzheimer's Disease Assessment Scale-cognitive component-Japanese version (ADAS-Jcog) and ABC dementia scales. At weeks 36 and 52, changes in ADAS-Jcog from week 24 [mean (standard deviation)] were 1.4 (4.8) and 2.1 (4.9) in the continuation group, and 1.0 (4.2), and 1.6 (5.4) in the switch group. The incidence of adverse events at application site in the continuation group over 52 weeks was 56.6% (98/173). Erythema, pruritus, and contact dermatitis at application site were observed in more than 10 patients each. There was no additional adverse event of clinical concern, and no increase in their incidence from the double-blind study. During the four weeks following switching, no patient discontinued or suspended administration due to adverse events.
Application of the patch for 52 weeks was well tolerated and feasible, including switching from tablets.
在日本，仅有盐酸多奈哌齐口服制剂被批准用于治疗阿尔茨海默病。
评估 27.5mg 多奈哌齐贴剂应用 52 周治疗轻中度阿尔茨海默病患者的安全性和疗效；并评估从盐酸多奈哌齐片转换的安全性。
这是一项 28 周、开放性标签研究（jRCT2080224517），是一项 24 周双盲（多奈哌齐贴剂 27.5mg 与盐酸多奈哌齐片 5mg 比较非劣效性）研究的延伸。该贴剂组（延续组）继续使用贴剂，而片剂组（转换组）在本研究中转换为贴剂。
共有 301 名患者参与（156 名患者继续使用贴剂；145 名患者转换）。两组在阿尔茨海默病评估量表-认知分量表-日本版（ADAS-Jcog）和 ABC 痴呆量表上均表现出相似的进程。在第 36 周和第 52 周，与第 24 周相比，ADAS-Jcog 的变化[平均值（标准差）]在延续组中分别为 1.4（4.8）和 2.1（4.9），在转换组中分别为 1.0（4.2）和 1.6（5.4）。延续组在 52 周内应用部位不良反应的发生率为 56.6%（98/173）。应用部位红斑、瘙痒和接触性皮炎的发生率均超过 10%。每个不良反应的发生率均超过 10%。没有其他临床关注的不良反应，且从双盲研究开始，其发生率没有增加。在转换后的四周内，没有患者因不良反应而停止或暂停治疗。
贴剂应用 52 周耐受性良好且可行，包括从片剂转换。
