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Table of Contents
Vol. 33, No. 5, 2012
Issue release date: July 2012
Section title: Original Research Article

Open Access Gateway

Dement Geriatr Cogn Disord 2012;33:341–353

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 J.a · Froelich L.c · Black S.E.d · Bakchine S.e · Bellelli G.f · Molinuevo J.L.g · Kressig R.W.h · Downs P.b · Caputo A.i · Strohmaier C.i
aCleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, N.V./Cleveland, Ohio, and bNovartis Pharmaceuticals Corporation, East Hanover, N.J., USA; cDepartment of Geriatric Psychiatry, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany; dNeurology Division, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ont., Canada; eHospital Maison Blanche, CMRR and Department of Neurology, Centre Hospitalo-Universitaire de Reims, Reims, France; fDepartment of Clinical and Preventive Medicine and Alzheimer Evaluation Unit, University Milano-Bicocca, Monza, and Geriatric Research Group, Brescia, Italy; gAlzheimer’s Disease and Other Cognitive Disorders Unit, ICN, Hospital Clínic i Universitari, Barcelona, Spain; hDepartment of Acute Geriatrics, University Hospital Basel, and iNovartis Pharma AG, Basel, Switzerland
email Corresponding Author

Prof. Jeffrey Cummings

Cleveland Clinic Lou Ruvo Center for Brain Health

888 W. Bonneville

Las Vegas, NV 89106 (USA)

Tel. +1 702 483 6029, E-Mail cumminj@ccf.org

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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 cm2) 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 cm2) 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.

© 2012 S. Karger AG, Basel

Article / Publication Details

First-Page Preview
Abstract of Original Research Article

Accepted: June 13, 2012
Published online: July 11, 2012
Issue release date: July 2012

Number of Print Pages: 13
Number of Figures: 2
Number of Tables: 4

ISSN: 1420-8008 (Print)
eISSN: 1421-9824 (Online)

For additional information: http://www.karger.com/DEM

Open Access License / Drug Dosage / Disclaimer

Open Access License: This is an Open Access article licensed under the terms of the Creative Commons Attribution-NonCommercial 3.0 Unported license (CC BY-NC) (www.karger.com/OA-license), applicable to the online version of the article only. Distribution permitted for non-commercial purposes only.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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