The ACTION study: Methodology of a trial to evaluate safety and efficacy of a higher dose rivastigmine transdermal patch in severe Alzheimer's disease

Martin R. Farlow, George Grossberg, Serge Gauthier, Xiangyi Meng, Jason T. Olin

Research output: Contribution to journalArticle

22 Scopus citations

Abstract

Background: Two sizes of rivastigmine patch (5cm2 and 10cm 2) are currently approved in the US and Europe, while a 20cm 2 rivastigmine patch has also been tested. A 15cm2 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. Objective: 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. Methods: 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 312. Novartis began recruitment in July 2009 and is conducting the trial in the United States. Patients are randomized to receive either a 5cm2 (4.5mg/24h) or a 15cm2 rivastigmine patch (13.3mg/24h) for 24 weeks. Patients receiving the 15cm2 patch will be up-titrated over 8 weeks, via 5 and 10cm2 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. Conclusions: The ACTION trial examines the efficacy and tolerability of a 15cm2 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.

Original languageEnglish (US)
Pages (from-to)2441-2447
Number of pages7
JournalCurrent Medical Research and Opinion
Volume26
Issue number10
DOIs
StatePublished - Oct 1 2010

Keywords

  • Activities of daily living
  • Alzheimer's disease
  • Cognition
  • Dose-response relationship
  • Drug
  • Rivastigmine
  • Transdermal administration

ASJC Scopus subject areas

  • Medicine(all)

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