eprintid: 17823
rev_number: 16
eprint_status: archive
userid: 1329
dir: disk0/00/01/78/23
datestamp: 2014-12-22 08:09:06
lastmod: 2015-02-05 06:39:08
status_changed: 2014-12-22 08:09:06
type: article
metadata_visibility: show
creators_name: Cummings, Jeffrey
creators_name: Frölich, Lutz
creators_name: Black, Sandra E.
creators_name: Bakchine, Serge
creators_name: Bellelli, Giuseppe
creators_name: Molinuevo, Jose L.
creators_name: Kressig, Reto W.
creators_name: Downs, Pamela
creators_name: Caputo, Angelika
creators_name: Strohmaier, Christine
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
subjects: ddc-610
divisions: i-851200
cterms_swd: Alzheimer-Krankheit
cterms_swd: Rivastigmin
abstract: 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 ADAScog 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
date: 2012
publisher: S. Karger AG
id_scheme: DOI
id_number: 10.11588/heidok.00017823
ppn_swb: 1495684458
own_urn: urn:nbn:de:bsz:16-heidok-178235
language: eng
bibsort: CUMMINGSJERANDOMIZED2012
full_text_status: public
publication: Dementia and geriatric cognitive disorders
volume: 33
number: 5
pagerange: 341-353
issn: 1420-8008
citation:   Cummings, Jeffrey ; Frölich, Lutz ; Black, Sandra E. ; Bakchine, Serge ; Bellelli, Giuseppe ; Molinuevo, Jose L. ; Kressig, Reto W. ; Downs, Pamela ; Caputo, Angelika ; Strohmaier, Christine  (2012) 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.  Dementia and geriatric cognitive disorders, 33 (5).  pp. 341-353.  ISSN 1420-8008     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/17823/1/DEM2012033005341.pdf