Investigating the Noradrenergic System in the Living Human Brain With Hybrid Molecular Functional Imaging
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
- 是
入选标准
- •for the healthy controls:
- •Age between 20 years and 80 years
- •Weight between 40 kilograms (kg) and 95kg
- •Without neurologic or psychiatric history
- •Without head trauma history including loss of consciousness superior to 30 minutes.
- •Affiliated to a social security or similar scheme
- •Not subject to any legal protection measures
- •Participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions
- •Inclusion Criteria for the patients with Parkinson's disease:
- •Age between 40 and 80 years old
- •Weight between 40 kilograms (kg) and 95kg
- •With an idiopathic Parkinson's disease (Dopa-sensitive)
- •Without head trauma history including loss of consciousness superior to 30 minutes.
- •Affiliated to a social security or similar scheme
- •Not subject to any legal protection measures
- •Participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions
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
干预措施: The role of the noradrenergic system across the life span (Healthy Subjects) (Other)
Parkinson disease
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)