Diving into the noradrenergic system : Role of the alpha2C-adrenergic receptors NA2C-TEP-IRM

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospices Civils De Lyon

Participant type

Patients, Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-04-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

ANR 2025 · Association France Parkinson

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

The primary objective of the NA2C-PET-MRI study is to evaluate in vivo, using the radiotracer [¹¹C]ORM-13070, the effect of normal aging and Parkinson's disease on the availability of α₂C-adrenergic receptors in the human brain.

Secondary objectives 3

1. Noradrenergic structure–function relation : Determine whether α2C receptor availability (measured by [¹¹C]ORM-13070 BPND) correlates with LC structural integrity, assessed by neuromelanin signal intensity on MRI (LC/pons contrast ratio).
2. Normal aging: imaging-behavior links. Determining the influence of changes in the noradrenergic system on behavioral changes during normal aging
3. Parkinson's disease: links between imaging and clinical phenotype. Determine the influence of alterations in the noradrenergic system on the clinical signs of PD.

Conditions and MedDRA coding

Neurology

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 17

1. Healthy volunteers : Age between 20 years and 80 years
2. Healthy volunteers : Weight between 40kg and 100kg
3. Healthy volunteers : Without neurologic or psychiatric history
4. Healthy volunteers : Without head trauma history including loss of consciousness superior to 30 minutes
5. Healthy volunteers : With highly effective contraception for women of childbearing age
6. Healthy volunteers : Affiliated to a social security or similar scheme
7. Healthy volunteers : Not subject to any legal protection measures
8. Healthy volunteers : Participant must have signed an informed consent document
9. Patients : Age between 40 years and 80 years
10. Patients : Weight between 40kg and 100kg
11. Patients : With an idiopathic Parkinson’s disease (Dopa-sensitive)
12. Patients : Without head trauma history including loss of consciousness superior to 30 minutes
13. Patients : Without associated neurological pathology
14. Patients : With highly effective contraception for women of childbearing age
15. Patients : Affiliated to a social security or similar scheme
16. Patients : Not subject to any legal protection measures
17. Patients : Participant must have signed an informed consent document

Exclusion criteria 11

1. Subject receiving (or having received in the last month) somatic medication with cerebral or psychological effects (e.g., antihistamines)
2. 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
3. Subjects already participating in another biomedical research project or who have participated in a study using ionizing radiation within the past year
4. Pregnant woman parturient or breastfeeding
5. 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
6. Subject with a contraindication to PET scans at the ORM : hypersensitivity to the active substance or to any of the excipients (sodium chloride)
7. Subjects who are unable to understand or complete the study (language barrier, obvious lack of motivation, etc.) as judged by the investigator
8. Subjects who do not agree to be informed in the event of an incidental finding of an abnormality on MRI or during neuropsychological assessment
9. Persons deprived of their liberty by judicial or administrative decision
10. Persons receiving psychiatric care
11. Persons admitted to a health or social care facility for purposes other than research

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Derived from the PET data, the binding potential (BPND) parametric maps will be calculated using compartmental modelling techniques. 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)

Secondary endpoints 3

1. Correlation coefficients between regional BPND and contrast ratio in the LC (signal intensity).
2. Correlation coefficients between PET-MRI indices of the noradrenergic system (α₂C BPND and contrast ratio in the LC) and performance: · cognitive: MoCA, TMT A/B, Stroop; · memory: RL/RI-16, digit memory (span); · Language: verbal fluency; · Visuospatial: VOSP score; · Olfactory: Sniffin' Sticks (TDI score); · Affective/Mood: apathy (LARS), depression (BDI-II), anxiety (STAI), fatigue (PDFS-16), impulsivity (UPPS) · Sleep: Epworth, RBDSQ; · Dysautonomic: SCOPA-AUT score; · Pain (EVA score)
3. Correlation coefficients between PET-MRI indices of the noradrenergic system (α₂C BPND and contrast ratio in the LC) and clinical and behavioral variables: Disease severity; Cognition; Memory; Language; Visuospatial ability; Olfactory, Affective/Mood; Sleep ; Dysautonomia ; Pain

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospices Civils De Lyon

Sponsor organisation

Hospices Civils De Lyon

Address

3 Quai Des Celestins, Bp 2251 Bp 2251

City

Lyon Cedex 02

Postcode

69229

Country

France

Scientific contact point

Organisation

Hospices Civils De Lyon

Contact name

Dr Chloé LAURENCIN

Public contact point

Organisation

Hospices Civils De Lyon

Contact name

Dr Chloé LAURENCIN

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications