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Clinical Trial
. 2017 Aug 7;12(8):e0182123.
doi: 10.1371/journal.pone.0182123. eCollection 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

Kyung Won Park  1 , Eun-Joo Kim  2 , Hyun Jeong Han  3 , Yong S Shim  4 , Jae C Kwon  5 , Bon D Ku  6 , Kee Hyung Park  7 , Hyon-Ah Yi  8 , Kwang K Kim  9 , Dong Won Yang  10 , Ho-Won Lee  11 , Heeyoung Kang  12 , Oh Dae Kwon  13 , SangYun Kim  14 , Jae-Hyeok Lee  15 , Eun Joo Chung  16 , Sang-Won Park  17 , Mee Young Park  18 , Bora Yoon  19 , Byeong C Kim  20 , Sang Won Seo  21 , Seong Hye Choi  22
Affiliations
Clinical Trial

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

Kyung Won Park et al. PLoS One. .

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.

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Conflict of interest statement

Competing Interests: KWP received funding from Novartis for this study. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials. There are no patents, products in development or marketed products to declare.

Figures

Fig 1
Fig 1. Flow chart of the study design and patient participation.
Fig 2
Fig 2. Changes from the baseline at 24 weeks in the ADAS-cog, MMSE, FAB, CGA-NPI, CDR-SB, ADCS-ADL, and Mini-Zarit (ITT-LOCF population) in the patients from groups 1 and 2.
See this image and copyright information in PMC

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