Department of Neurology, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA.
Curr Med Res Opin. 2010 Oct;26(10):2441-7. doi: 10.1185/03007995.2010.513849.
Two sizes of rivastigmine patch (5 cm(2) and 10 cm(2)) are currently approved in the US and Europe, while a 20 cm(2) rivastigmine patch has also been tested. A 15 cm(2) rivastigmine patch may provide an optimal balance between efficacy and safety. Earlier studies have demonstrated the efficacy of rivastigmine in severe Alzheimer's disease (AD), and supported the use of a higher dose patch in AD.
The ACTION (ACTivities of daily living and cognitION) trial (Study CENA713DUS44) is designed to evaluate the efficacy and safety of low-dose versus high-dose rivastigmine transdermal patch in patients with severe AD.
ACTION is a prospective, randomized, parallel-group, double-blind, multicenter study of patients (aged ≥50 years) with severe AD and a Mini-Mental State Examination score of 3-12. Novartis began recruitment in July 2009 and is conducting the trial in the United States. Patients are randomized to receive either a 5 cm(2) (4.5 mg/24 h) or a 15 cm(2) rivastigmine patch (13.3 mg/24 h) for 24 weeks. Patients receiving the 15 cm(2) patch will be up-titrated over 8 weeks, via 5 and 10 cm(2) patches. The primary efficacy outcomes include activities of daily living (ADLs), assessed with the Alzheimer's Disease Cooperative Study - Activities of Daily Living - Severe Impairment Version (ADCS-ADL-SIV), and cognition, assessed with the Severe Impairment Battery (SIB). Secondary outcomes include behavior (Neuropsychiatric Inventory), global functioning (Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change), response rates, and safety.
The ACTION trial examines the efficacy and tolerability of a 15 cm(2) rivastigmine patch over a 24-week period in patients with severe AD. This is a novel trial in the development of rivastigmine, as it uses a design that does not include a placebo arm, is recruiting patients with severe AD, and includes an ADL measure as a co-primary efficacy variable. CLINICAL REGISTRATION NUMBER: CENA713D US44.
两种规格的rivastigmine 贴片（5cm(2) 和 10cm(2)）目前已在美国和欧洲获得批准，而一种 20cm(2) 的 rivastigmine 贴片也已进行了测试。15cm(2) 的 rivastigmine 贴片可能在疗效和安全性之间达到最佳平衡。早期的研究已经证明了 rivastigmine 在严重阿尔茨海默病（AD）中的疗效，并支持在 AD 中使用更高剂量的贴片。
ACTION（日常活动和认知）试验（Study CENA713DUS44）旨在评估低剂量与高剂量 rivastigmine 透皮贴片在严重 AD 患者中的疗效和安全性。
ACTION 是一项前瞻性、随机、平行组、双盲、多中心研究，纳入了年龄≥50 岁的严重 AD 患者（Mini-Mental State Examination 评分 3-12）。诺华于 2009 年 7 月开始招募患者，并在美国开展这项试验。患者被随机分配接受 5cm(2)（4.5mg/24h）或 15cm(2) rivastigmine 贴片（13.3mg/24h）治疗 24 周。接受 15cm(2)贴片治疗的患者将在 8 周内通过 5cm(2)和 10cm(2)贴片进行滴定。主要疗效结局包括使用 Alzheimer's Disease Cooperative Study - Activities of Daily Living - Severe Impairment Version（ADCS-ADL-SIV）评估的日常生活活动（ADL），以及使用严重损害认知量表（SIB）评估的认知。次要结局包括行为（神经精神疾病问卷）、整体功能（Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change）、应答率和安全性。
ACTION 试验在 24 周内评估了 15cm(2) rivastigmine 贴片在严重 AD 患者中的疗效和耐受性。这是 rivastigmine 开发中的一项新试验，因为它采用了一种不包括安慰剂组的设计，招募了严重 AD 患者，并将 ADL 测量作为主要疗效变量之一。临床试验注册号：CENA713D US44。
