NCT02546310已完成1 期
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Phase 1, Exploratory Study Investigating the Effects of HTL0009936 on Cognition and BOLD fMRI Signals in Healthy Elderly Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Blood oxygen level dependent (BOLD) signal in functional Magnetic Resonance Imaging (fMRI) of the brain areas associated with cognitive tasks
研究概览
简要总结
To determine if treatment with HTL0009936 will lead to changes in neural activity, measured using the fMRI BOLD signal and ASL, in brain areas that are associated with spatial and working memory, learning and executive functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of medical history, physical examination, vital signs, 12-lead ECG, haematology, blood chemistry, urinalysis and a pre-study psychological assessment.
- •Mini Mental State Examination (MMSE) Score of ≥
- •Intermediate or extensive metaboliser as determined by CYP2D6 genotype.
- •Fluent English speaker.
- •Right-handed.
- •Not a regular smoker
排除标准
- •Recreational drug use within 3 months prior to Screening Visit.
- •Positive alcohol breath test.
- •Positive urine drug screen.
- •Consumption of large amounts of caffeinated drinks.
- •Consumption of any food or any drinks containing cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges.
- •Ultra-rapid or poor metabolizer as determined by CYP2D6 genotype.
- •By self-report, taking two or more daytime naps per week which in the opinion of the investigator is likely to interfere with the ability of the subject to complete the study procedures.
- •History of, or presents (in the opinion of the Investigator) with, significant neurological or psychiatric conditions.
- •Personal or family history of congenital long QT syndrome or sudden death.
- •Concomitant use of drugs that are metabolised by and/or are inhibitors of CYP2D
- •Concomitant use of drugs that are substrates for the organic cation transporter
- •History of significant claustrophobia.
- •Fulfils any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants).
研究组 & 干预措施
HTL0009936 high dose
Experimental
high dose infusion
干预措施: HTL0009936 (Drug)
HTL0009936 low dose
Experimental
low dose infusion
干预措施: HTL0009936 (Drug)
HTL0009936 matching placebo
Placebo Comparator
matching infusion
干预措施: HTL0009936 matching placebo (Drug)
结局指标
主要结局
Blood oxygen level dependent (BOLD) signal in functional Magnetic Resonance Imaging (fMRI) of the brain areas associated with cognitive tasks
时间窗: Day 1
次要结局
- BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during cognitive tasks(Day 1)
- cerebral blood flow, assessed using Arterial Spin Labelling (ASL)(Day 1)
- adverse events(Day 1)
- blood pressure(Day 1)
- 12-lead electrocardiogram(Day 1)
研究者
研究点 (1)
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