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.

抽象的 阿尔茨海默氏痴呆 (AD) 是最常见的衰老神经退行性疾病，影响认知、 情绪、行为。激越是一种常见的行为综合症，经常出现在中年时期。 到 AD 晚期，其特征是精神运动性过度活跃、攻击性、易怒、大喊大叫、抵抗 照顾，失眠。烦躁和相关行为障碍的不良后果是 相当大的影响，包括生活质量受损、认知能力加速下降、罹患疾病的风险增加 制度化，以及发病率和死亡率的增加。烦躁也会增加护理人员的负担， 包括压力和有害的健康后果。然而，尽管骚动造成了破坏性影响 对于患者和护理人员来说，目前的治疗效果有限。行为管理策略 广泛使用，但仅在轻微情况下有效。抗精神病药，最常用的一类 对照研究显示，用于治疗痴呆症躁动和精神病的药物，结果好坏参半 并与发病率和死亡率升高相关。因此，显然需要改进 干预措施，特别是针对 AD 中的严重躁动。 电休克疗法 (ECT) 是一种安全有效的治疗后期严重情绪障碍的方法 生活，包括并发精神病、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 在治疗躁动性痴呆方面的临床应用。均具有回顾性 我们小组进行的前瞻性研究支持 ECT 对 AD 患者的安全性和有效性 和剧烈的躁动。因此，ECT 可能是治疗 AD 严重躁动的有效方法。我们 提出一项五中心、随机、单盲、对照临床试验，以确定其安全性和有效性 200 名住院患者中 ECT 加常规护理与模拟 ECT (S-ECT) 加常规护理的比较 患有中度至重度 AD 期的个体，可能是阿尔茨海默病类型（基于 NIA-AA 标准）， 因剧烈搅动而复杂化。受试者将被随机分配至 (1) ECT，为期三周（最多 9 ECT 治疗）加上常规护理（UC），定义为标准行为疗法和药物疗法或（2）模拟 ECT (S-ECT) 加 UC。主要疗效将通过科恩-曼斯菲尔德激动量表 (CMAI) 进行测量。 安全参数包括每日评估谵妄（混乱评估方法，CAM）、认知 （严重损伤电池，SIB-8）和严重不良事件。为期 12 周的随访包括每月 评估以探索搅拌减少的稳定性。