A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
Oxytocin is a hormone produced by the brain that appears to have important roles in social cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia were investigated. The results from the pilot study suggested that oxytocin may be associated with a modest improvement in neuropsychiatric behaviours seen in patients with Frontotemporal Dementia. To further examine the safety and tolerability of oxytocin in this disorder, the present study will examine the safety and tolerability of three different doses of intranasal oxytocin administered to patients with Frontotemporal Dementia twice daily for 1 week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-80 years
- •Meets "Neary criteria" for diagnosis of probable frontotemporal dementia
- •Neuroimaging (CT, MRI or SPECT scan) supports diagnosis of frontotemporal dementia
- •Provides written informed consent and has a caregiver or legally acceptable representative who provides written informed consent.
排除标准
- •Has a history of a myocardial infarction within the last two years or congestive heart failure.
- •Current uncontrolled hypertension
- •Current bradycardia (rate < 50 beats per minute/bpm) or tachycardia (rate > 100 bpm)
- •Current hyponatremia
- •Current use of prostaglandin medications
- •Females who are pregnant or breastfeeding
- •Use of any investigational or experimental drug or device within the last 60 days prior to screening or within 5 half-lives of the experimental drug , whichever is longer.
研究组 & 干预措施
Oxytocin 24IU
Oxytocin 24 IU administered intranasally twice daily for 1 week
干预措施: oxytocin (Drug)
Oxytocin 48 IU
48 IU of intranasal oxytocin administered twice daily for 1 week
干预措施: oxytocin (Drug)
72 IU oxytocin
72 IU of intranasal oxytocin administered twice daily for 1 week
干预措施: oxytocin (Drug)
Saline nasal spray
干预措施: oxytocin (Drug)
Saline nasal spray
干预措施: Saline Nasal Mist (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 2 week
Safety and Tolerability of 24 international units (IU), 48 IU and 72 IU of intranasal oxytocin administered twice daily for 1 week to patients with Frontotemporal Dementia as assessed by the number of participants with adverse events. Adverse events will be assessed by a standardized questionnaire and serum sodium levels will be monitored.
次要结局
- Neuropsychiatric Inventory(1 week)
- Frontal Behavioural Inventory(1 week)
- Clinicians Global Impression of Change(1 week)
- Clinical Dementia Rating- Frontotemporal Lobar Degeneration(1 week)
- Interpersonal Reactivity Index(1 week)
- Multi-faceted Empathy Test(1 week)
研究者
Elizabeth Finger
Cognitive Neurologist
Lawson Health Research Institute