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: 10411985
• 负责人: Brent Peter Forester
• 金额: --
• 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/10411985
• 关键词: Acceleration; Affect; Aggressive behavior; Aging; Agitation; Alzheimer' s Disease; Alzheimer' s disease patient; Antidepressive Agents; Antipsychotic Agents; Attention; Behavior; Behavior Therapy; Behavioral; Behavioral Symptoms; Caregiver Burden; Caregivers; Caring; Catatonia; Clinical; Clinical Trials; Cognition; Cognitive; Collaborations; Controlled Clinical Trials; Controlled Study; Country; Data; Delirium; Dementia; Development; Diagnosis; Elderly; Electroconvulsive Therapy; Emotions; Equipment and supply inventories; Health; Hospitalization; Impaired cognition; Impairment; Individual; Inpatients; Institutionalization; Intervention; Long-Term Care; Manic; Measures; Mental Depression; Mood Disorders; Morbidity - disease rate; National Institute on Alcohol Abuse and Alcoholism; Neurodegenerative Disorders; Outcome; Outpatients; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Physiologic pulse; Probability; 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; behavioral disinhibition; blind; caregiver stress; confusion assessment method; cooperative study; design; effective intervention; effective therapy; efficacy study; follow-up; impression; improved; meetings; mortality; mortality risk; neuropsychiatric symptom; neuropsychiatry; novel; novel therapeutic intervention; 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.

抽象的 阿尔茨海默氏症的痴呆（AD）是衰老的最普遍的神经退行性疾病，会影响认知， 情感和行为。躁动是一种常见的行为综合征，经常在中间出现 到后期AD，其特征是精神运动多动，攻击性，易怒，大喊大叫，抵抗力 照顾和失眠。躁动和相关行为干扰的不利后果是 相当大，包括生活质量受损，认知能力下降，风险增加 制度化，发病率和死亡率增加。躁动也增加了照顾者的负担， 包括压力和有害健康后果。然而，尽管激动造成破坏性影响 在患者和护理人员上，目前的治疗只有适中的功效。行为管理策略 被广泛使用，但仅在温和的情况下有效。抗精神病药，最常用的类 在对照研究中，痴呆症的躁动和精神病药物表现出不同的结果 并与发病率和死亡率升高有关。因此，显然需要改进 干预措施，尤其是为了严重的AD搅动。 电抽取疗法（ECT）是治疗严重情绪障碍的安全有效干预措施。 生活，包括精神病，躁狂或卡塔尼症复杂的抑郁症。对不良认知的担忧 但是，ECT的影响限制了ECT在躁动中治疗痴呆症中的临床用途。两者都回顾 我们小组进行的前瞻性研究支持ECT在AD患者中的安全性和功效 和严重的搅动。因此，ECT可能代表对AD中严重搅动的有效处理。我们 提出了一项五个站点，随机的单盲，对照临床试验，以确定的安全性和功效 与模拟ECT（S-ECT）以及200次住院的平常护理相比，ECT加上通常的护理 具有中度至重度阶段AD的个体，可能是阿尔茨海默氏症类型（基于NIA-AA标准）， 严重的搅动使其复杂。受试者将随机分为（1）ECT三周（最多9个ECT 治疗）以及常规护理（UC），定义为标准行为疗法和药物治疗或（2）模拟 ECT（S-ECT）加UC。一级功效将使用Cohen-Mansfield搅动库存（CMAI）测量。 安全参数包括ir妄的每日评估（混乱评估方法，CAM），认知 （严重的减值电池，SIB-8）和严重的不良事件。一项为期12周的随访包括每月一次 评估以探索减少搅拌的稳定性。