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Randomized, double-blind, parallel-group, 48-week study for efficacy and safety of a higher-dose rivastigmine patch (15 vs. 10 cm²) in Alzheimer’s disease


Cummings, Jeffrey, Froelich, Lutz, Black, Sandra E., Bakchine, Serge, Bellelli, Giuseppe, Molinuevo, José L., Kressig, Reto W., Downs, Pamela, Caputo, Angelika, Strohmaier, Christine


Dementia And Geriatric Cognitive Disorders, Volume: 33, No.: 5, Pages.: 341-353

Year of Publication



Aim: 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.; Methods: 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.; Results: 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.; Conclusions: 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.; Copyright © 2012 S. Karger AG, Basel.

Bibtex Citation

@article{Cummings_2012, doi = {10.1159/000340056}, url = {}, year = 2012, publisher = {S. Karger {AG}}, volume = {33}, number = {5}, pages = {341--353}, author = {Jeffrey Cummings and Lutz Froelich and Sandra E. Black and Serge Bakchine and Giuseppe Bellelli and Jos{'{e}} L. Molinuevo and Reto W. Kressig and Pamela Downs and Angelika Caputo and Christine Strohmaier}, title = { Randomized, Double-Blind, Parallel-Group, 48-Week Study for Efficacy and Safety of a Higher-Dose Rivastigmine Patch (15 vs. 10 cm 2 ) in Alzheimer’s Disease }, journal = {Dementia and Geriatric Cognitive Disorders} }


activities of daily living, administration & dosage, adverse, aged, aged, 80 and over, alzheimer disease, cholinesterase inhibitors, disease progression, drug therapy, events, female, humans, male, middle aged, phenylcarbamates, rivastigimine, transdermal patch, treatment outcome

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Cognition, Other

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

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