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A 24-week, randomized, controlled trial of rivastigmine patch 13.3 mg/24 h versus 4.6 mg/24 h in severe Alzheimer’s dementia


Farlow, Martin R., Grossberg, George T., Sadowsky, Carl H., Meng, Xiangyi, Somogyi, Monique


CNS Neuroscience & Therapeutics, Volume: 19, No.: 10, Pages.: 745-752

Year of Publication



Aims: The 24-week, prospective, randomized, double-blind ACTION study investigated the efficacy, safety, and tolerability of 13.3 versus 4.6 mg/24 h rivastigmine patch in patients with severe Alzheimer’s disease (AD).; Methods: Patients had probable AD and Mini-Mental State Examination scores ≥3-≤12. Primary outcome measures were as follows: Severe Impairment Battery (SIB) and AD Cooperative Study-Activities of Daily Living scale-Severe Impairment Version (ADCS-ADL-SIV). Secondary outcomes were as follows: ADCS-Clinical Global Impression of Change (ADCS-CGIC), 12-item Neuropsychiatric Inventory (NPI-12), and safety/tolerability.; Results: Of 1014 patients screened, 716 were randomized to 13.3 mg/24 h (N = 356) or 4.6 mg/24 h (N = 360) patch. Baseline characteristics/demographics were comparable. Completion rates were as follows: 64.3% (N = 229) with 13.3 mg/24 h and 65.0% (N = 234) with 4.6 mg/24 h patch. The 13.3 mg/24 h patch was significantly superior to 4.6 mg/24 h patch on cognition (SIB) and function (ADCS-ADL-SIV) at Week 16 (P < 0.0001 and P = 0.049, respectively) and 24 (primary endpoint; P < 0.0001 and P = 0.025). Significant between-group differences (Week 24) were observed on the ADCS-CGIC (P = 0.0023), not NPI-12 (P = 0.1437). A similar proportion of the 13.3 mg/24 h and 4.6 mg/24 h patch groups reported adverse events (AEs; 74.6% and 73.3%, respectively) and serious AEs (14.9% and 13.6%).; Conclusions: The 13.3 mg/24 h patch demonstrated superior efficacy to 4.6 mg/24 h patch on SIB and ADCS-ADL-SIV, without marked increase in AEs, suggesting higher-dose patch has a favorable benefit-to-risk profile in severe AD.; © 2013 The Authors. CNS Neuroscience & Therapeutics published by John Wiley & Sons Ltd.

Bibtex Citation

@article{Farlow_2013, doi = {10.1111/cns.12158}, url = {}, year = 2013, month = {aug}, publisher = {Wiley-Blackwell}, pages = {n/a--n/a}, author = {Martin R. Farlow and George T. Grossberg and Carl H. Sadowsky and Xiangyi Meng and Monique Somogyi}, title = {A 24-Week, Randomized, Controlled Trial of Rivastigmine Patch 13.3~mg/24~h Versus 4.6~mg/24~h in Severe Alzheimer{textquotesingle}s Dementia}, journal = {{CNS} Neuroscience {&} Therapeutics} }


administration & dosage, aged, aged, 80 and over, alzheimer disease, clinical trial, double-blind method, drug therapy, female, humans, male, middle aged, neuroprotective agents, patch, phenylcarbamates, prospective studies, psychology, rivastigmine, severe alzheimers disease, severity of illness index, transdermal patch

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