Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 5
- 主要终点
- CMAI total score
研究概览
简要总结
This study will explore the effect of ECT treatments plus usual care (ECT+UC) in reducing severe agitation in patients with moderate to severe dementia including Alzheimer's Disease, Vascular dementia, Frontotemporal dementia, and Dementia with Lewy Bodies. The study will also determine the tolerability/safety outcomes of ECT+UC.
详细描述
This study will be a single-arm, unblinded, non-randomized trial to determine the effect and safety of ECT for severe agitation in moderate to severe stage dementia, while also examining the durability of the acute treatment effect in an exploratory maintenance naturalistic design. We plan to enroll 50 participants with an estimated dropout rate of 20%. We expect 50 participants to complete at least 1 ECT treatment before moving into the 12-month naturalistic follow-up phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Dementia, of the following subtypes,
- •Alzheimer's dementia, according to NIA-AA Criteria for dementia
- •Vascular dementia based on:
- •i. History consistent with insidious onset of illness and gradual clinical decline ii. MRI evidence of microvascular ischemic disease (microinfarcts) iii. Physical and neurological examination do not indicate current or prior stroke c. Frontotemporal dementia d. Dementia with Lewy Bodies
- •Mini Mental Status Exam (MMSE) less than or equal to 15
- •Cohen-Mansfield Agitation Inventory Nursing Home Version (CMAI) score of 5 or more on at least one item or score of 4 on two items of aggression or physical nonaggression that holds potentially dangerous consequences including hitting (including self), kicking, grabbing onto people, pushing, throwing things, biting, scratching, spitting, hurting self or other, tearing things or destroying property, making physical sexual advances, trying to get to a different place, or intentional falling (items 1-11, 14, 15) OR one score of 5 or more in items of verbal aggression including screaming, making verbal sexual advances, and cursing or verbal aggression (items 22-24).
- •At least one failed pharmacological intervention to manage behavioral symptoms
- •Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries and brain imaging when clinically indicated
- •Comprehension of English language
- •Authorized legal representative able and willing to give informed consent
- •Age 40 and above
排除标准
- •Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (CAM) and by clinical diagnosis
- •Diagnosis of vascular dementia due to stroke, based on:
- •History consistent with abrupt onset and step-wise progression of cognitive and functional decline
- •MRI scan within the past 12 months demonstrating evidence of hemorrhagic and embolic stroke
- •Physical and neurologic examination consistent with current or prior stroke
- •Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder
- •Active substance use disorder within past 6 months
- •Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months
研究组 & 干预措施
ECT+UC group
ECT with Usual Care
干预措施: Electroconvulsive Therapy (ECT) (Device)
结局指标
主要结局
CMAI total score
时间窗: The CMAI will be collected through study completion, about 13 months
The CMAI measures the efficacy of ECT+UC in reducing severe agitation in AD subjects. The CMAI is a 29-item scale with each item ranging from 1-7 in frequency with 7 being the highest and therefore worst outcome.
次要结局
- Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC)(The ADCS-CGIC will be collected for one month)
- Neuropsychiatric Inventory, Clinician Version (NPI-C)(The NPI-C will be collected for one month)
- Pittsburgh Agitation Scale (PAS)(The PAS will be collected for one month)
研究者
Brent Forester
Principal Investigator
Mclean Hospital