A Randomized Controlled Trial of Electroconvulsive Therapy plus Usual Care versus Simulated-ECT plus Usual Care for the Acute Management of Severe Agitation in Alzheimer's Dementia (ECT-AD)

电惊厥疗法加常规护理与模拟 ECT 加常规护理对阿尔茨海默氏痴呆症严重激越急性管理 (ECT-AD) 的随机对照试验

• 批准号: 10224086
• 负责人: Brent Peter Forester
• 金额: $ 232.43万
• 依托单位: MCLEAN HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10224086
• 关键词: Affect; Aggressive behavior; Aging; Agitation; Alzheimer' s Disease; Antidepressive Agents; Antipsychotic Agents; Attention; Behavior; Behavior Therapy; Behavioral; Behavioral Symptoms; Caregiver Burden; Caregivers; Caring; Catatonia; Clinical; Clinical Trials; Cognition; Cognitive; Confusion; Controlled Clinical Trials; Controlled Study; Data; Delirium; Dementia; Development; Diagnosis; Elderly; Electroconvulsive Therapy; Emotions; Equipment and supply inventories; Health; Impaired cognition; Impairment; Individual; Inpatients; Institutionalization; Intervention; Long-Term Care; Manic; Measures; Mental Depression; Mood Disorders; Morbidity - disease rate; Neurodegenerative Disorders; Outcome; Outpatients; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Physiologic pulse; Prospective Studies; Psychoses; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Refractory; Resistance; Retrospective Studies; Risk; Safety; Serious Adverse Event; Severities; Single-Blind Study; Site; Sleeplessness; Specific qualifier value; Stimulus; Stress; Support Groups; Syndrome; Techniques; United States; Universities; acute care; base; behavioral disinhibition; blind; confusion assessment method; cooperative study; design; effective intervention; effective therapy; efficacy study; follow-up; impression; improved; meetings; mortality; mortality risk; neuropsychiatric symptom; neuropsychiatry; novel; open label; primary outcome; safety and feasibility; safety outcomes; secondary outcome; treatment as usual

ABSTRACT Alzheimer's dementia (AD), the most prevalent neurodegenerative disease of aging, affects cognition, emotion, and behavior. Agitation is a common behavioral syndrome that frequently emerges during middle to late stage AD and is characterized by psychomotor hyperactivity, aggression, irritability, yelling, resistance to care, and insomnia. The untoward consequences of agitation and related behavioral disturbances are considerable and include impaired quality of life, accelerated cognitive decline, heightened risk of institutionalization, and increased morbidity and mortality. Agitation also increases caregiver burden, including stress and deleterious health consequences. However, despite the damaging impact of agitation on the patient and caregiver, current treatments have only modest efficacy. Behavior management strategies are widely employed, but effective only in mild cases. Antipsychotics, the most commonly used class of medication for agitation and psychosis in dementia, have demonstrated mixed results in controlled studies and are associated with elevated morbidity and mortality. Thus, there is a clear need for improved interventions, particularly for severe agitation in AD. Electroconvulsive Therapy (ECT) is a safe and effective intervention for severe mood disorders in later life, including depression complicated by psychosis, mania or catatonia. Concerns regarding adverse cognitive effects of ECT, however, have limited ECT's clinical use in treating dementia with agitation. Both retrospective and prospective studies conducted by our group support the safety and efficacy of ECT in patients with AD and severe agitation. ECT, therefore, may represent an effective treatment of severe agitation in AD. We propose a five-site, randomized, single-blind, controlled clinical trial to determine the safety and efficacy of ECT plus usual care compared with Simulated ECT (S-ECT) plus usual care in 200 hospitalized individuals with moderate to severe stage AD , probable Alzheimer's type (based on NIA-AA criteria), complicated by severe agitation. Subjects will be randomized to either (1) ECT for three weeks (up to 9 ECT treatments) plus usual care (UC), defined as standard behavioral therapy and pharmacotherapy or (2) Simulated ECT (S-ECT) plus UC. Primary efficacy will be measured with the Cohen-Mansfield Agitation Inventory (CMAI). Safety parameters include daily assessment of delirium (Confusion Assessment Method, CAM), cognition (Severe Impairment Battery, SIB-8) and serious adverse events. A 12-week follow-up includes monthly assessments to explore stability of agitation reduction.

摘要 阿尔茨海默病(AD)是最常见的老年神经退行性疾病，影响认知， 情感和行为。激越是一种常见的行为综合征，常见于中年 到晚期阿尔茨海默病，以精神运动多动、攻击性、易怒、大喊大叫、抵抗为特征 去关心，去失眠。情绪激动和相关行为障碍的不良后果是 相当大，包括生活质量受损，认知能力下降加速，罹患高血压的风险增加 制度化，以及发病率和死亡率的增加。情绪激动也增加了照顾者的负担， 包括压力和有害的健康后果。然而，尽管骚乱造成了破坏性的影响 对于患者和护理者，目前的治疗方法只有适度的疗效。行为管理策略 被广泛使用，但仅在轻微病例中有效。抗精神病药物，最常用的一类 在对照研究中，治疗痴呆症的激动症和精神病的药物效果喜忧参半。 并与较高的发病率和死亡率有关。因此，显然需要改进 干预措施，特别是对AD患者的严重骚动。 电休克治疗(ECT)是治疗晚期严重情绪障碍的一种安全有效的干预方法 生活，包括伴有精神病、躁狂症或紧张症的抑郁症。对不良认知的担忧 然而，ECT的效果限制了ECT在治疗躁动型痴呆方面的临床应用。两者都是回顾 我们小组进行的前瞻性研究支持电休克治疗AD患者的安全性和有效性 以及严重的骚动。因此，电休克疗法可能是治疗阿尔茨海默病严重激越的有效方法。我们 提出一项五点、随机、单盲、对照的临床试验，以确定该药的安全性和有效性。 200例住院患者电休克加常规护理与模拟电休克加常规护理的比较 中至重度AD、可能的阿尔茨海默病类型(根据NIA-AA标准)、 更复杂的是严重的骚动。受试者将随机接受(1)ECT治疗三周(最多9次ECT 治疗)加常规护理(UC)，定义为标准行为疗法和药物疗法或(2)模拟 ECT(S-ECT)+UC。初步疗效将使用科恩-曼斯菲尔德激越问卷(CMAI)进行评估。 安全参数包括日常精神错乱评估(混淆评估法，CAM)、认知 (严重损害电池，SIB-8)和严重不良事件。为期12周的随访包括每月一次 探索减震稳定性的评估。