Diving Into the in Vivo Noradrenergic System : Role of the alpha2C-adrenergic Receptors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- PET 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 (here Parkinson's disease) through the use of a newly developed radiotracer visualizing alpha2C-ARs ([11C]ORM-13070) combined with a cutting-edge technology, the hybrid PET/MRI scanner. The secondary aim will be to determine whether the expected age- and PD-related changes in the noradrenergic system are paralleled by changes in neuropsychological performances (i.e. 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 40kg and 100kg
- •Without neurologic or psychiatric history
- •Without head trauma history including loss of consciousness superior to 30 minutes.
- •With highly effective contraception for women of childbearing age
- •Affiliated to a social security or similar scheme
- •Not subject to any legal protection measures
- •Participant must have signed an informed consent document
- •Inclusion Criteria for the patients with Parkinson's disease:
- •Age between 40 years and 80 years
- •Weight between 40kg and 100kg
- •With an idiopathic Parkinson's disease (Dopa-sensitive)
- •Without head trauma history including loss of consciousness superior to 30 minutes.
- •Without associated neurological pathology
- •With highly effective contraception for women of childbearing age
- •Affiliated to a social security or similar scheme
- •Not subject to any legal protection measures
- •Participant must have signed an informed consent document
排除标准
- •for all participants :
- •Subject receiving (or having received in the last month) somatic medication with cerebral or psychological effects (e.g., antihistamines), see list in Appendix1
- •Subjects with a current or past dependence on alcohol or any other addictive substance according to DSM-IV-TR criteria, with the exception of nicotine and caffeine; -
- •Subjects already participating in another biomedical research project or who have participated in a study using ionizing radiation within the past year;
- •Pregnant woman parturient or breastfeeding
- •MRI contraindications (: people using pacemaker or insulin pumps, with implanted or embedded metal objects in the head or body, claustrophobic, with neurosensory stimulators or implantable defibrillators, with cochlear implants, with ferromagnetic foreign bodies in the eye or brain close to nerve structures, agitation of the subject (uncooperative or agitated subjects), ventriculoperitoneal neurosurgical shunt valves, dental appliances)
- •Subject with a contraindication to PET scans at the ORM: hypersensitivity to the active substance or to any of the excipients (sodium chloride)
- •Subjects who are unable to understand or complete the study (language barrier, obvious lack of motivation, etc.) as judged by the investigator.
- •Subjects who do not agree to be informed in the event of an incidental finding of an abnormality on MRI or during neuropsychological assessment.
- •Persons deprived of their liberty by judicial or administrative decision.
- •Persons receiving psychiatric care.
- •Persons admitted to a health or social care facility for purposes other than research.
研究组 & 干预措施
Healthy controls
120 healthy participants (balanced for sex) ranging from 20 to 80 years old will be included.
干预措施: Neuropsychological examination (Behavioral)
Parkinson's disease
45 parkinsonian patients with an akineto-rigid phenotype will be included.
干预措施: Olfactory screening (Behavioral)
Healthy controls
120 healthy participants (balanced for sex) ranging from 20 to 80 years old will be included.
干预措施: PET/MRI scanning session (Other)
Healthy controls
120 healthy participants (balanced for sex) ranging from 20 to 80 years old will be included.
干预措施: Olfactory screening (Behavioral)
Parkinson's disease
45 parkinsonian patients with an akineto-rigid phenotype will be included.
干预措施: PET/MRI scanning session (Other)
Parkinson's disease
45 parkinsonian patients with an akineto-rigid phenotype will be included.
干预措施: Neuropsychological examination (Behavioral)
结局指标
主要结局
PET measures
时间窗: Day 1
Derived from the PET data, the binding potential (BPND) parametric maps will be calculated using compartmental modelling techniques.
IRM measure
时间窗: Day 1
Derived from the MRI data, the LC will be defined with a semi-automatic method from the MRI sequence sensitive to neuromelanin, and its signal intensity will be calculated for each participant as previously described (Laurencin et al., 2024a)
次要结局
- Global Cognitive Assessment(Day 2)
- Memory Assessment(Day 2)
- Working memory Assessment(Day 2)
- Executive Functioning(Day 2)
- Planning Functioning(Day 2)
- Verbal fluencies(Day 2)
- Visuo-spatial Assessment(Day 2)
- Depression Evaluation(Day 1)
- Anxiety Evaluation(Day 1)
- Day time sleepiness evaluation(Day 2)
- Sleep Quality(Day 2)
- Rapid Eye Movement Behavior disorder(Day 2)
- Pain Assessment(Day 1)
- Apathy Assessment(Day 2)
- Fatigue Assessment(Day 2)
- Impulsivity assessment(Day 2)
- Autonomic function(Day 2)
- Olfactory assessment: odor threshold(Day 2)
- Olfactory assessment: odor discrimination(Day 2)
- Olfactory assessment: odor identification(Day 2)