In Vivo Noradrenergic System and Aging
NA2C-PET-MRI
Diving Into the in Vivo Noradrenergic System : Role of the alpha2C-adrenergic Receptors
2 other identifiers
interventional
165
1 country
1
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 (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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2026
CompletedFirst Posted
Study publicly available on registry
May 6, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
Study Completion
Last participant's last visit for all outcomes
October 1, 2029
May 6, 2026
April 1, 2026
3.3 years
April 28, 2026
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PET measures
Derived from the PET data, the binding potential (BPND) parametric maps will be calculated using compartmental modelling techniques.
Day 1
IRM measure
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)
Day 1
Secondary Outcomes (20)
Global Cognitive Assessment
Day 2
Memory Assessment
Day 2
Working memory Assessment
Day 2
Executive Functioning
Day 2
Planning Functioning
Day 2
- +15 more secondary outcomes
Study Arms (2)
Healthy controls
OTHER120 healthy participants (balanced for sex) ranging from 20 to 80 years old will be included.
Parkinson's disease
EXPERIMENTAL45 parkinsonian patients with an akineto-rigid phenotype will be included.
Interventions
Each participant will undergo 45 min of PET/MRI recording that will begin immediately after an intravenous bolus injection of \[11C\]ORM-13070 (350 MBq ± 10%) and will last for 45 minutes in a resting state. During this time, MRI acquisition will include several MRI sequences: 1) One sagittal MP-RAGE sequence of high-resolution anatomical 3D T1-weighted images (5 min); 2) One 3D T2 FLAIR sequence (5 min); (3) One turbo spin-echo (TSE) neuromelanin-sensitive sequence (7 min, Garcia-Lorenzo et al., 2013); 3) One echo-planar imaging (EPI) sequence in the axial plane (15 min duration) to acquire diffusion images; and 4) One 13-min resting-state fMRI run using high resolution T2\* weighted gradient-echo EPI sequences covering the entire brain and including the lower brainstem.
A battery of neuropsychological tests will assess cognitive, emotional, and sensory domains linked to noradrenaline function. Participants will complete the Montreal Cognitive Assessment for global cognitive function, the Digit Span and Free Recall tests for memory, the Trail Making, Tower of London and Stroop tests for executive functioning, Beck Depression Inventory for mood, State-Trait Anxiety Inventory for anxiety, the Epworth and RBD screening questionnaire for sleep, the visual analog and Kings PD scales for pain, the Lille Apathy Rating Scale for apathy, the VOSP for visuo-spatial capacity, the PDFS-16 for fatigue, the UPPS for impulsivity, and the SCOPA-AUT for autonomic assessment.
An olfactory screening (30-40 min) using the extended ODOFIN (BURGHART) Sniffin' Sticks Test battery (Burghart Messtechnik Denmark). This battery consists of 3 tests: The threshold (T) test has 48 Sniffin' Sticks (32 blanks and 16 dilutions with 2-Phenylethanol) and is used to ascertain the participant's olfactory threshold. The discrimination (D) test consists of 48 Sniffin' Sticks (16 triplets of odorants) where the participant must tell the odd one out in the triplet. The identification (I) test consists of 16 Sniffin' Sticks with everyday smells which the participant has to name using a selection card containing four choices. Together, these make up the TDI score.
Eligibility Criteria
You may qualify if:
- 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
- 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
- +2 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Neurologique Pierre Wertheimer - Service de Neurologie
Bron, 69500, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2026
First Posted
May 6, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
October 1, 2029
Last Updated
May 6, 2026
Record last verified: 2026-04