Clinical trial NCT03942289: Human Aging and in Vivo Noradrenergic System
Official title: Investigating the Noradrenergic System in the Living Human Brain With Hybrid Molecular Functional Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Human
Aging
Behavior
Noradrenergic system
Positron Emission Tomography
Magnetic Resonance Imaging
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 135
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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).


Eligibility criteria: Inclusion Criteria 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) measures
timeFrame: Day 1 -180 minutes
Secondary outcomes:
measure: Global Cognitive Assessment
timeFrame: Day 2 - 10 minutes
measure: Memory Assessment
timeFrame: Day 2 - 20 minutes
measure: Working Memory Assessment
timeFrame: Day 2 - 20 minutes
measure: Executive Functioning
timeFrame: Day 2 - 20 minutes
measure: Planning Functioning
timeFrame: Day 2 - 20 minutes
measure: Visuo-spatial Assessment
timeFrame: Day 2 - 20 minutes
measure: Depression Evaluation
timeFrame: Day 2 - 10 minutes
measure: Anxiety Evaluation
timeFrame: Day 2 - 10 minutes
measure: Praxic Abilities
timeFrame: Day 2 - 10 minutes
measure: Day time sleepiness evaluation
timeFrame: Day 2 - 5 minutes
measure: Sleep Quality
timeFrame: Day 2 - 5 minutes
measure: Olfactory assessment : odor detection
timeFrame: Day 2 - 30 minutes
measure: Olfactory assessment: odor discrimination
timeFrame: Day 2 - 30 minutes
measure: Olfactory assessment : odor identification
timeFrame: Day 2 - 30 minutes
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Neurologique Pierre Wertheimer, Groupement Hospitalier Est
Study officials:
affiliation: Hospices Civils de Lyon
name: Chloé Laurencin, MD
role: PRINCIPAL_INVESTIGATOR
References: