Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
CNS Drugs. 2011 May;25(5):425-33. doi: 10.2165/11588160-000000000-00000.
Agitation and aggression are common neuropsychiatric symptoms of Alzheimer's disease (AD) with a negative impact on caregivers.
The aim of the study was to determine whether changes in agitation and aggression would follow memantine treatment and, if so, be associated with changes in nursing burden in institutionalized patients with moderate to severe AD.
This was a 3-month open-label trial of memantine.
The setting was two long-term care facilities.
Thirty-one institutionalized patients with moderate to severe AD and significant behavioural and psychiatric symptoms were included in the study.
Memantine was titrated to a target dose of 10 mg twice daily.
Effectiveness was assessed by the change in the Neuropsychiatric Inventory-Nursing Home (NPI-NH) agitation/aggression subscale and Clinical Global Impression of Change (CGI-C) scale using the intent-to-treat population. To establish caregiver impact, the effect on nursing burden was measured by the Modified Nursing Care Assessment Scale (primary outcome). As a secondary analysis, the caregiver distress subscale of the NPI-NH was examined, as well as changes in as required (pro re nata [prn]) psychotropic medication use.
Twenty-four patients completed the study. A significant decrease in agitation and aggression (F-test with 3 and 90 degrees of freedom [F(3,90)] = 3.721, p = 0.014) was demonstrated following memantine, with 48% of patients improving (either much improved or minimally improved) on the CGI-C scale. In addition, nursing burden (t-test with 30 degrees of freedom [t(30)] = 3.02, p = 0.005), caregiver distress (F(3,90) = 4.125, p = 0.009) and the use of prn psychotropics decreased following memantine treatment (Z = -1.99, p = 0.046). Fourteen patients experienced at least one adverse event during memantine treatment. The most common adverse event associated with treatment was somnolence (n = 5).
The results of this study suggest that the decreased agitated and aggressive behaviour in institutionalized patients with moderate to severe AD following treatment with memantine was accompanied by improvements in nursing burden and decreased psychotropic use. These findings should be confirmed in a larger, controlled trial.
激越和攻击是阿尔茨海默病（AD）的常见神经精神症状，对护理人员有负面影响。
本研究旨在确定美金刚治疗后激越和攻击是否会发生变化，如果会发生变化，是否与中重度 AD 住院患者的护理负担变化相关。
这是一项为期 3 个月的美金刚开放性标签试验。
该研究在两个长期护理机构进行。
31 名患有中重度 AD 且存在明显行为和精神症状的住院患者被纳入研究。
美金刚滴定至目标剂量 10mg，每日两次。
采用意向治疗人群评估神经精神疾病问卷-养老院（NPI-NH）激越/攻击亚量表和临床总体印象变化量表（CGI-C）的变化来评估疗效。为了确定护理人员的影响，采用改良护理评估量表（主要结局）测量对护理负担的影响。作为次要分析，还检查了 NPI-NH 的护理人员困扰亚量表，以及按需（prn）使用精神药物的变化。
24 名患者完成了研究。在接受美金刚治疗后，激越和攻击显著减少（F 检验自由度为 3 和 90 [F(3,90)]=3.721，p=0.014），48%的患者在 CGI-C 量表上改善（明显改善或轻度改善）。此外，护理负担（t 检验自由度为 30 [t(30)]=3.02，p=0.005）、护理人员困扰（F(3,90)=4.125，p=0.009）和 prn 精神药物的使用在接受美金刚治疗后减少（Z=-1.99，p=0.046）。14 名患者在接受美金刚治疗期间至少经历了一次不良事件。与治疗相关的最常见不良事件是嗜睡（n=5）。
本研究结果表明，中重度 AD 住院患者接受美金刚治疗后激越和攻击行为减少，同时护理负担减轻，精神药物使用减少。这些发现应在更大的对照试验中得到证实。
