Effects of rivastigmine treatment on the neuropsychiatric and behavioral disturbances of nursing home residents with moderate to severe probable Alzheimer's disease: a 26-week, multicenter, open-label study.
Effects of rivastigmine treatment on the neuropsychiatric and behavioral disturbances of nursing home residents with moderate to severe probable Alzheimer's disease: a 26-week, multicenter, open-label study.
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DOI：
10.1016/s1543-5946(05)80020-0
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发表时间：
2005-09-01
期刊：
影响因子：
--
通讯作者：
Mirski, Dario
中科院分区：
文献类型：
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作者：
Cummings, Jeffrey L;Koumaras, Barbara;Mirski, Dario
背景技术背景：阿尔茨海默病（Alzheimer's disease，AD）是最常见的痴呆形式，临床上以认知能力逐渐下降、日常生活活动能力日益受损以及神经精神和行为障碍为特征。目的：本研究的目的是评估利斯的明对中重度疑似AD的疗养院居民的神经精神和行为障碍的影响，评估rivastigmine在这一人群中的安全性和耐受性。方法：这项前瞻性的、为期26周的、开放标签的研究在美国的13个中心进行，共涉及29家疗养院。在患有中重度疑似AD的疗养院居民中评估了rivastigmine 3 - 12 mg/d治疗26周的效果。使用神经精神病量表-护理之家（NPI-NH）量表评估神经精神和行为障碍的疗效;使用简易精神状态检查和阿尔茨海默病评估量表-认知子量表的命名子集评估认知表现;使用简化的基于临床医生访谈的变化印象加护理人员输入评估整体功能。共入组173例患者（141例女性，32例男性;平均[SD]年龄，82.6 [5.9]岁）。rivastigmine治疗26周后，观察病例人群中所有治疗患者较基线的平均（SD）变化为-2.5（16.4）（n = 100; P = 0.138）;末次观察值结转人群为-0.8（16.5）（n = 149; P = 0.576）。基线时存在至少1种神经精神症状的患者显示NPI-NH总评分平均改善3.2分（n = 92; P = 0.062），其中49%的患者显示较基线有临床意义的降低（即≥ 30%）。在26周时，基线时存在特定症状的患者的12种神经精神和行为障碍中的8种评分显示出较基线的统计学显著改善（妄想32例，幻觉15例，激越58例，冷漠37例，差异有统计学意义（P <0.001））。P < 0.001]、易怒/不稳定[n = 50; P < 0.001]、异常运动行为[n = 32; P < 0.001]、夜间干扰[n = 22; P < 0.001]和食欲/进食变化[n = 28; P = 0.002]）。本研究的局限性包括，它是开放标签，并不限于患者的行为障碍在basel.CONCLUSION：在目前的研究中，rivastigmine治疗26周的疗养院居民与中度至重度可能的AD与减少NPI-NH项目评分为一个广泛的行为障碍在亚组的患者在基线时的行为症状。
BACKGROUND: Alzheimer's disease (AD) is the most common form of dementia and is characterized clinically by a gradual decline in cognitive performance, an increasingly impaired ability to perform activities of daily living, and neuropsychiatric and behavioral disturbances.OBJECTIVE: The goal of this study was to assess the effect of rivastigmine on the neuropsychiatric and behavioral disturbances of nursing home residents with moderate to severe probable AD and to evaluate the safety and tolerability of rivastigmine in this population.METHODS: This prospective, 26-week, open-label study was conducted in 13 centers in the United States and involved a total of 29 nursing homes. The effects of rivastigmine 3 to 12 mg/d for 26 weeks were assessed in nursing home residents with moderate to severe probable AD. Efficacy was evaluated using the Neuropsychiatric Inventory-Nursing Home (NPI-NH) scale for neuropsychiatric and behavioral disturbances; the Mini-Mental State Examination and the naming subset of the Alzheimer's Disease Assessment Scale-Cognitive subscale for cognitive performance; and the simplified Clinician's Interview-Based Impression of Change Plus Caregiver Input for global functioning.RESULTS: A total of 173 patients (141 women, 32 men; mean [SD]age, 82.6 [5.9] years) were enrolled. After 26 weeks of rivastigmine treatment, the mean (SD) change from baseline for all treated patients in the observed cases population was -2.5 (16.4) (n = 100; P = 0.138); it was -0.8 (16.5) (n = 149; P = 0.576) for the last-observation-carried-forward population. Patients with at least 1 neuropsychiatric symptom present at baseline showed a 3.2-point mean improvement in NPI-NH total score (n = 92; P = 0.062), with 49% of these patients demonstrating a clinically meaningful (ie, > or = 30%) reduction from baseline. At 26 weeks, scores for 8 of the 12 neuropsychiatric and behavioral disturbances in patients with the specific symptom present at baseline showed statistically significant improvements from baseline (delusions [n = 32; P = 0.007], hallucinations [n = 15; P < 0.001], agitation [n = 58; P = 0.044], apathy/indifference [n = 37; P < 0.001], irritability/lability [n = 50; P < 0.001], aberrant motor behavior [n = 32; P < 0.001], nighttime disturbances [n = 22; P < 0.001], and appetite/eating changes [n = 28; P = 0.002]) in the observed cases population. Limitations of this study include that it was open label and not restricted to patients with behavioral disturbances at baseline.CONCLUSION: In the current study, rivastigmine treatment for 26 weeks in nursing home residents with moderate to severe probable AD was associated with decreased NPI-NH item scores for a wide range of behavioral disturbances in the subgroup of patients with behavioral symptoms at baseline.