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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 DiseaseCummings 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 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 email@example.com
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