Methylphenidate Primed iTBS for Apathy in Neurocognitive Disorders
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Neuropsychiatric Inventory-Apathy (NPI-A) score
研究概览
简要总结
This study evaluates whether the combined treatment of methylphenidate and non-invasive brain stimulation, called intermittent theta burst stimulation, can effectively treat apathy in individuals with Alzheimer's disease or mixed AD/vascular dementia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alzheimer's disease or mixed Alzheimer's disease and vascular disease
- •MMSE score 10-28 inclusive
- •Clinically significant apathy
- •Stable dose of psychotropic medication
- •Care partner must spend at least 10hrs/week with the participant
排除标准
- •Major Depressive Episode
- •Clinically significant agitation, delusions, hallucinations
- •Currently talking a dopaminergic agent other than methylphenidate
- •Failure to clear the TMS adult safety scale (e.g. unapproved pacemakers, metallic implants, history of epilepsy)
- •Central nervous system abnormalities (other than Alzheimer's disease) deemed clinically significant by study physician or seizures
- •Any condition that in the opinion of the study physician, makes it medically unsafe for the patient to enroll in the trial
研究组 & 干预措施
Methylphenidate + iTBS
Participants are currently receiving methylphenidate and receive iTBS in this study.
干预措施: intermittent theta burst stimulation (iTBS) (Device)
Methylphenidate + iTBS
Participants are currently receiving methylphenidate and receive iTBS in this study.
干预措施: Methylphenidate (MPH) (Drug)
iTBS only
iTBS only, no medication for apathy
干预措施: intermittent theta burst stimulation (iTBS) (Device)
结局指标
主要结局
Change in Neuropsychiatric Inventory-Apathy (NPI-A) score
时间窗: 2 weeks
Assesses apathy total (frequency x severity) using the NPI-A based on scores provided by the care-partner through an interview with the assessor. Scores range from 0-12 with a higher score representing worse apathy.
次要结局
未报告次要终点