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 DiseaseCummings J. · Froelich L. · Black S.E. · Bakchine S. · Bellelli G. · Molinuevo J.L. · Kressig R.W. · Downs P. · Caputo A. · Strohmaier C.
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
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.
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 email@example.com
Accepted: June 13, 2012
Published online: July 11, 2012
Number of Print Pages : 13
Dementia and Geriatric Cognitive Disorders
Vol. 33, No. 5, Year 2012 (Cover Date: July 2012)
Journal Editor: Chan-Palay V. (Boston, Mass.)
ISSN: 1420-8008 (Print), eISSN: 1421-9824 (Online)
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