Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV 89106, USA.
Dement Geriatr Cogn Disord. 2012;33(5):341-53. doi: 10.1159/000340056. Epub 2012 Jul 11.
Determine whether patients with Alzheimer's disease demonstrating functional and cognitive decline, following 24-48 weeks of open-label treatment with 9.5 mg/24 h (10 cm(2)) rivastigmine patch, benefit from a dose increase in a double-blind (DB) comparative trial of two patch doses.
Patients meeting prespecified decline criteria were randomized to receive 9.5 or 13.3 mg/24 h (15 cm(2)) patch during a 48-week, DB phase. Coprimary outcomes were change from baseline to week 48 on the Instrumental Activities of Daily Living domain of the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-IADL) scale and the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). Safety and tolerability were assessed.
Of 1,584 patients enrolled, 567 met decline criteria and were randomized. At all timepoints, ADCS-IADL and ADAS-cog scores favoured the 13.3 mg/24 h patch. The 13.3 mg/24 h patch was statistically superior to the 9.5 mg/24 h patch on the ADCS-IADL scale from week 16 (p = 0.025) onwards including week 48 (p = 0.002), and ADAS-cog at week 24 (p = 0.027), but not at week 48 (p = 0.227). No unexpected safety concerns were observed.
The 13.3 mg/24 h rivastigmine patch significantly reduced deterioration in IADL, compared with the 9.5 mg/24 h patch, and was well tolerated.
确定在使用利伐斯的明贴片（9.5 毫克/24 小时，10 平方厘米）进行 24-48 周开放性治疗后，认知和功能出现下降的阿尔茨海默病患者，是否能从两种剂量的贴片双盲（DB）对比试验中增加剂量中获益。
符合预定义下降标准的患者被随机分配接受 9.5 或 13.3 毫克/24 小时（15 平方厘米）的贴片，在 48 周的 DB 阶段进行治疗。主要终点是从基线到第 48 周时，阿尔茨海默病合作研究-日常生活活动量表（ADCS-IADL）的工具性日常生活活动（IADL）领域和阿尔茨海默病评估量表认知子量表（ADAS-cog）的变化。评估安全性和耐受性。
在纳入的 1584 名患者中，有 567 名符合下降标准并被随机分组。在所有时间点，ADCS-IADL 和 ADAS-cog 评分均有利于 13.3 毫克/24 小时的贴片。13.3 毫克/24 小时的贴片在第 16 周（p=0.025）开始，包括第 48 周（p=0.002），以及第 24 周的 ADAS-cog（p=0.027），优于 9.5 毫克/24 小时的贴片，但第 48 周时没有统计学意义（p=0.227）。没有观察到新的安全性问题。
与 9.5 毫克/24 小时的贴片相比，13.3 毫克/24 小时的利伐斯的明贴片显著减少了 IADL 的恶化，并且耐受性良好。
