Please use this identifier to cite or link to this item: https://doi.org/10.1371/journal.pone.0182123
Title: Efficacy and tolerability of rivastigmine patch therapy in patients with mild-to-moderate Alzheimer’s dementia associated with minimal and moderate ischemic white matter hyperintensities: A multicenter prospective open-label clinical trial
Authors: Park K.W.
Kim E.-J.
Han H.J.
Shim Y.S.
Kwon J.C.
Ku B.D.
Park K.H.
Yi H.-A.
Kim K.K.
Yang D.W. 
Lee H.-W.
Kang H.
Kwon O.D.
Kim S.
Lee J.-H.
Chung E.J.
Park S.-W.
Park M.Y.
Yoon B.
Kim B.C.
Seo S.W.
Choi S.H.
Keywords: rivastigmine
cholinesterase inhibitor
neuroprotective agent
rivastigmine
abscess
aged
Alzheimer disease
Alzheimer Disease Assessment Scale
anorexia
Article
bradycardia
clinical trial
dizziness
drug dose titration
drug efficacy
drug tolerability
drug withdrawal
dyspnea
edema
epigastric discomfort
epigastric pain
female
fracture
headache
herpes zoster
human
intention to treat analysis
major clinical study
male
multicenter study
nausea
nervous system parameters
open study
paresthesia
prospective study
pruritus
rash
shoulder pain
skin irritation
treatment outcome
upper respiratory tract infection
vomiting
white matter
white matter hyperintensity
Alzheimer disease
brain
diagnostic imaging
drug effects
middle aged
severity of illness index
South Korea
transdermal patch
very elderly
white matter
Aged
Aged, 80 and over
Alzheimer Disease
Brain
Cholinesterase Inhibitors
Female
Humans
Male
Middle Aged
Neuroprotective Agents
Republic of Korea
Rivastigmine
Severity of Illness Index
Transdermal Patch
Treatment Outcome
White Matter
Issue Date: 2017
Citation: Park K.W., Kim E.-J., Han H.J., Shim Y.S., Kwon J.C., Ku B.D., Park K.H., Yi H.-A., Kim K.K., Yang D.W., Lee H.-W., Kang H., Kwon O.D., Kim S., Lee J.-H., Chung E.J., Park S.-W., Park M.Y., Yoon B., Kim B.C., Seo S.W., Choi S.H. (2017). Efficacy and tolerability of rivastigmine patch therapy in patients with mild-to-moderate Alzheimer’s dementia associated with minimal and moderate ischemic white matter hyperintensities: A multicenter prospective open-label clinical trial. PLoS ONE 12 (8) : e0182123. ScholarBank@NUS Repository. https://doi.org/10.1371/journal.pone.0182123
Abstract: Background and objective: Studies investigating the impact of white matter hyperintensities (WMHs) on the response of acetylcholinesterase inhibitors in patients with Alzheimer’s disease (AD) have presented inconsistent results. We aimed to compare the effects of the rivastigmine patch between patients with AD with minimal WMHs and those with moderate WMHs. Methods: Three hundred patients with mild to moderate AD were enrolled in this multicenter prospective open-label study and divided into two groups. Group 1 comprised patients with AD with minimal WMHs and group 2 comprised those with moderate WMHs. The patients were treated with a rivastigmine patch for 24 weeks. Efficacy measures were obtained at baseline and after 24 weeks. The primary endpoint was the change in the AD Assessment Scale-Cognitive subscale (ADAS-Cog) from the baseline to the end of the study. Results: Of the 300 patients, there were 206 patients in group 1 and 94 patients in group 2. The intention-to-treat group comprised 198 patients (group 1, n = 136; group 2, n = 46) during the 24-week study period. Demographic factors did not differ between group 1 and group 2. There were no significant differences in change in ADAS-cog between group 1 (-0.62±5.70) and group 2 (-0.23±5.98) after the 24-week rivastigmine patch therapy (p = 0.378). The patients in group 1 had a 0.63-point improvement from baseline on the Frontal Assessment Battery, while group 2 had a 0.16-point decline compared to baseline at the end of the study (p = 0.037). The rates of adverse events (AEs) (42.6 vs. 40.3%) and discontinuation due to AEs (10.3% vs. 4.3%) did not differ between the groups. Conclusions: Although the efficacy and tolerability of rivastigmine patch therapy were not associated with WMH severity in patients with AD, some improvement in frontal function was observed in those with minimal WMHs. Trial registration: ClinicalTrials.gov NCT01380288. © 2017 Park et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Source Title: PLoS ONE
URI: https://scholarbank.nus.edu.sg/handle/10635/161180
ISSN: 19326203
DOI: 10.1371/journal.pone.0182123
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