Comparison of the effects of transdermal and oral rivastigmine on cognitive function and EEG markers in patients with Alzheimer's disease.

Comparison of the effects of transdermal and oral rivastigmine on cognitive function and EEG markers in patients with Alzheimer's disease.
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DOI:
10.3389/fnagi.2014.00179
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发表时间:
2014
影响因子:
4.8
通讯作者:
Zanetti O
Zanetti O
中科院分区:
医学2区
文献类型:
--
作者:
Moretti DV;Frisoni GB;Binetti G;Zanetti O

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背景:阿尔茨海默病(AD)是老年人痴呆的最常见原因。卡巴拉汀(RV,Exelon,Novartis)是一种可逆性胆碱酯酶抑制剂,可改善AD的临床表现,并可能增强ACh调制的脑电图(EEG)α频率。本初步研究旨在确定两种RV制剂[透皮贴剂(RV-TDP)和口服胶囊(TV-CP)]对AD患者的α频率(特别是后优势节律)和认知功能[通过简易精神状态检查(MMSE)评估]的影响。方法:AD受试者被分配接受RV-TDP 10 cm 2或RV-CP 12 mg/天。所有患者在18个月研究期开始和结束时使用P3、P4、O 1和O2电极进行EEG记录,每个电极的频率为高(10.5-13.0 Hz)和低(8.0-10.5 Hz)。在研究开始时(T0)和连续三个6个月的间隔(T1、T2和T3)测定MMSE评分。结果如下:RV-TDP给药(n = 10)维持了认知功能,表现为基线至18个月期间MMSE评分稳定(21.07 ± 2.4-21.2 ± 3.1),而RV-CP给药(n = 10)在18个月期间MMSE评分降低[18.3 ± 3.6-13.6 ± 5.06(经协变量校正,p = 0.006)]。从6个月开始,治疗组之间的MMSE评分存在显著差异(p = 0.04)。从基线到18个月,RV-TDP还增加了用电极P3测量的后部区域α波的频谱功率,显著高于TV-CP;分别为80%和30%[p = 0.025(χ2检验)]。结论:与RV-CP治疗相比,RV-TDP与18个月时后区α波谱功率增加和认知功能显著提高的患者比例更高相关。我们的研究结果表明,与口服RV-CP相比,RV-TDP为AD患者提供了一种有效的长期管理选择。本研究是一项具有明确探索性目的且患者数量较少的初探性、开放标签研究。需要进一步的随机、双盲、安慰剂对照试验研究,更大的样本量以及健康对照来支持这些初步结果。
Background: Alzheimer’s disease (AD) is the most common cause of dementia in older patients. Rivastigmine (RV, Exelon, Novartis), a reversible cholinesterase inhibitor, improves clinical manifestations of AD and may enhance ACh-modulated electroencephalogram (EEG) alpha frequency. This pilot study aimed to determine the effects of two formulations of RV [transdermal patch (RV-TDP) and oral capsules (TV-CP)] on alpha frequency, in particular the posterior dominant rhythm, and cognitive function [assessed by the Mini-Mental State Examination (MMSE)] in patients with AD. Methods: Subjects with AD were assigned to receive either RV-TDP 10 cm2 or RV-CP 12 mg/day. All patients underwent EEG recordings at the beginning and end of the 18-month study period using P3, P4, O1, and O2 electrodes, each at high (10.5–13.0 Hz) and low (8.0–10.5 Hz) frequency. MMSE scores were determined at the start of the study (T0) and at three successive 6-month intervals (T1, T2, and T3). Results: RV-TDP administration (n = 10) maintained cognitive function as evidenced by stable MMSE scores from baseline to 18 months (21.07 ± 2.4–21.2 ± 3.1) compared with a decrease in MMSE score with RV-CP (n = 10) over 18 months [18.3 ± 3.6–13.6 ± 5.06 (adjusted for covariates p = 0.006)]. MMSE scores were significantly different between treatment groups from 6 months (p = 0.04). RV-TDP also increased the spectral power of alpha waves in the posterior region measured with electrode P3 in a significantly great percentage of patients than TV-CP from baseline to 18 months; 80% vs 30%, respectively [p = 0.025 (χ2 test)]. Conclusions: RV-TDP was associated with a greater proportion of patients with increased posterior region alpha wave spectral power and significantly higher cognitive function at 18 months, compared with RV-CP treatment. Our findings suggest that RV-TDP provides an effective long-term management option in patients with AD compared with oral RV-CP. This study is a pilot, open-label study with a clear explorative purpose and with a small number of patients. Further randomized, double-blind, placebo-controlled trial studies with a bigger sample size as well as healthy controls are needed to support these initial results.
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发表时间: 2012-03-06
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