Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Functional magnetic resonance imaging (fMRI) BOLD signal
研究概览
简要总结
This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.
详细描述
Frontotemporal dementia (FTD) and Pick's disease cause changes in personality, behaviour, and emotional responses. The usual treatments for Frontotemporal dementia focus on reducing agitation and aggressive behaviours. However, these drugs do not help all patients who experience blunting of emotion and loss of empathy. This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 30-85
- •meet consensus criteria for probable behavioural variant FTD (bvFTD)
- •Age and sex matched with patients
- •Mini-Mental State Exam (MMSE) scores >27
排除标准
- •history of stroke
- •intracranial haemorrhage or other medical or neurological disorder apart from FTD that could affect cognition
- •diagnosis of bipolar disorder or schizophrenia not better accounted for by the diagnosis of FTD
- •cognitive impairment that precludes comprehension of task instructions
- •contraindication to MRI scanning
- •severe language or memory deficits that preclude participation in the study visits and measures
- •females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause).
- •uncontrolled hypertension
- •bradycardia (rate <48 bpm) or tachycardia (rate > 100 bpm)
- •current use of prostaglandins
- •history of stroke
- •intracranial haemorrhage or other medical or neurological disorder
- •diagnosis of bipolar disorder or schizophrenia
- •cognitive impairment that precludes comprehension of task instructions
- •contraindication to MRI scanning
- •severe language or memory deficits that preclude participation in the study visits and measures
- •females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause).
- •uncontrolled hypertension
- •bradycardia (rate <48 bpm) or tachycardia (rate > 100 bpm)
- •current use of prostaglandins
研究组 & 干预措施
Intranasal Oxytocin
Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3
干预措施: Intranasal oxytocin (Drug)
Saline Nasal Mist
Participants will be randomized to receive intranasal saline mist (placebo) on opposite visits from the interventional drug visit 2 or 3
干预措施: Saline Nasal Mist (Drug)
结局指标
主要结局
Functional magnetic resonance imaging (fMRI) BOLD signal
时间窗: 2 weeks
Measures of BOLD (Blood Oxygen-Level Dependent) signal change during oxytocin compared to placebo during functional MRI scans
次要结局
- Cognitive and Emotional Task performance(2 weeks)
研究者
Elizabeth Finger
Principle Investigator
Lawson Health Research Institute