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


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


Current Medical Research And Opinion, Volume: 26, No.: 10, Pages.: 2441-2447

Year of Publication



Background: 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.; 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 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.; Conclusions: 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.;

Bibtex Citation

@article{Farlow_2010, doi = {10.1185/03007995.2010.513849}, url = {}, year = 2010, month = {sep}, publisher = {Informa Healthcare}, volume = {26}, number = {10}, pages = {2441--2447}, author = {Martin R. Farlow and George Grossberg and Serge Gauthier and Xiangyi Meng and Jason T. Olin}, title = {The {ACTION} study: methodology of a trial to evaluate safety and efficacy of a higher dose rivastigmine transdermal patch in severe Alzheimer{textquotesingle}s disease}, journal = {Current Medical Research and Opinion} }


administration & dosage, adverse effects, aged, aged, 80 and over, alzheimer disease, clinical protocols, cognition, double-blind method, drug effects, drug therapy, female, humans, male, middle aged, neuroprotective agents, neuropsychological tests, patch, phenylcarbamates, placebos, rivastigmine, severity of illness index, transdermal patch, treatment outcome

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Behaviour, Cognition

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime