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临床试验/NCT03942289
NCT03942289Unknown不适用

Investigating the Noradrenergic System in the Living Human Brain With Hybrid Molecular Functional Imaging

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2019年4月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
135
试验地点
1
主要终点
Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) measures

研究概览

简要总结

The main goal of this research proposal is to provide, for the first time in humans, a wider understanding of the role of the noradrenergic system both in health and illness (Parkinson's disease) through the use of a newly developed radiotracer (11Carbon [11C]Yohimbine) visualizing alpha-2 (α2) adrenergic receptors (AR) combined with cutting-edge technology, the hybrid positron emission tomography (PET)/magnetic resonance imaging (MRI) scanner. The secondary aim of this study will be to determine whether the expected age- and Parkinson's disease (PD)-related changes in the noradrenergic system are paralleled by changes in neuropsychological performances (such as cognitive, motor and/or olfactory abilities).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Subject with alcohol or substance abuse history
  • Subject with somatic drug therapies
  • Magnetic Resonance Imaging (MRI) contraindications (implanted or embedded metal objects in the head or body)
  • Positron Emission Tomography (PET) contraindications
  • Exposed to 1 millisievert or more of ionizing radiation in the year before the start of this study
  • Subject unable to sign written consent for participation in the study

研究组 & 干预措施

Healthy controls

Experimental

干预措施: The role of the noradrenergic system across the life span (Healthy Subjects) (Other)

Parkinson disease

Experimental

干预措施: The role of the noradrenergic system across the life span (Parkinson's Disease Subjects) (Other)

结局指标

主要结局

Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) measures

时间窗: Day 1 -180 minutes

Derived from the Positron Emission Tomography (PET) data, the binding potentials will be calculated using compartmental modelling techniques. Derived from the Magnetic Resonance Imaging (MRI) data.

次要结局

  • Global Cognitive Assessment(Day 2 - 10 minutes)
  • Memory Assessment(Day 2 - 20 minutes)
  • Working Memory Assessment(Day 2 - 20 minutes)
  • Olfactory assessment : odor detection(Day 2 - 30 minutes)
  • Planning Functioning(Day 2 - 20 minutes)
  • Visuo-spatial Assessment(Day 2 - 20 minutes)
  • Anxiety Evaluation(Day 2 - 10 minutes)
  • Olfactory assessment : odor identification(Day 2 - 30 minutes)
  • Depression Evaluation(Day 2 - 10 minutes)
  • Olfactory assessment: odor discrimination(Day 2 - 30 minutes)
  • Executive Functioning(Day 2 - 20 minutes)
  • Praxic Abilities(Day 2 - 10 minutes)
  • Day time sleepiness evaluation(Day 2 - 5 minutes)
  • Sleep Quality(Day 2 - 5 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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