ACTRN12617001531303终止4 期
Pilot study: Intranasal oxytocin administration as a potential symptomatic intervention treatment to improve emotion recognition in patients with dementia
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 60 Years 至 90 Years（—）
- 性别
- All
入选标准
- •To be eligible participants must:
- •1. 60 to 90 years of age
- •2. Have a diagnosis of mild AD, Vascular Dementia or mixed AD / Vascular Dementia
- •(MMSE >= 20)
- •3. Have a carer who will be able to live with the participant during the study
排除标准
- •Participants will be excluded if they:
- •1. Have prior history of psychiatric disorders (e.g. major depression, schizophrenia, bipolar disorder)
- •2. Have a score of =< 40 on the Benton Facial Recognition Test
- •3. Have a score on the 18-item Hamilton Depression Rating Scale greater than 16
- •4. Have been prescribed an anticholinesterase medication for less than three months or are experiencing side effects secondary to this class of medication.
- •5. Have been prescribed an antidepressant medication for less than one month or if they are experiencing side effects related to this medication or if the particular antidepressant is contraindicated with an INOT intervention
- •6. Currently prescribed any of the following classes of medications: non-anticholinesterase medications for dementia, antipsychotics, benzodiazepines, sedatives, and hypnotics
- •7. Have prior history of neurological disorder (e.g., head injury, stroke or transient ischemic attack, epilepsy)
- •8. Have a diagnosis of another neurodegenerative disease (e.g., Dementia with Lewy Bodies, Frontotemporal Dementia, Parkinson’ Disease Dementia)
- •9. Have an intellectual disability
- •10. Have a current history of substance abuse
- •11. Has a history of a myocardial infarction within the last two years or congestive heart failure
- •12. Current uncontrolled hypertension
- •13. Current bradycardia (rate < 50 beats per minute/bpm) or tachycardia (rate > 100 bpm)
- •14. Has a diagnosis of long QT syndrome
- •15. Current use of prostaglandins and their analogues
- •16. Current use of any anaesthetic (inhalation or caudal)
- •17. Known allergies to oxytocin or to preservatives in the nasal spray
- •18. Participants with severe nasal obstruction/blockage
- •19. Participants with severely compromised hepatic function
- •20. Participants with severely compromised renal function
研究者
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