2025-524602-15-00RecruitingPhase 2
Diving into the noradrenergic system : Role of the alpha2C-adrenergic receptors NA2C-TEP-IRM
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Hospices Civils De Lyon
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
Brief Summary
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.
Study Design
- Allocation
- Na
- Primary Purpose
- [11c]orm-13070
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteers : Age between 20 years and 80 years
- •Patients : Weight between 40kg and 100kg
- •Patients : With an idiopathic Parkinson’s disease (Dopa-sensitive)
- •Patients : Without head trauma history including loss of consciousness superior to 30 minutes
- •Patients : Without associated neurological pathology
- •Patients : With highly effective contraception for women of childbearing age
- •Patients : Affiliated to a social security or similar scheme
- •Patients : Not subject to any legal protection measures
- •Patients : Participant must have signed an informed consent document
- •Healthy volunteers : Weight between 40kg and 100kg
- •Healthy volunteers : Without neurologic or psychiatric history
- •Healthy volunteers : Without head trauma history including loss of consciousness superior to 30 minutes
- •Healthy volunteers : With highly effective contraception for women of childbearing age
- •Healthy volunteers : Affiliated to a social security or similar scheme
- •Healthy volunteers : Not subject to any legal protection measures
- •Healthy volunteers : Participant must have signed an informed consent document
- •Patients : Age between 40 years and 80 years
Exclusion Criteria
- •Subject receiving (or having received in the last month) somatic medication with cerebral or psychological effects (e.g., antihistamines)
- •Persons receiving psychiatric care
- •Persons admitted to a health or social care facility for purposes other than research
- •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
Arms & Interventions
[11C]ORM-13070
Test
Intervention: [11C]ORM-13070 (Drug)
Outcomes
Primary Outcomes
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)
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 Outcomes
- Correlation coefficients between regional BPND and contrast ratio in the LC (signal intensity).
- 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)
- 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
Investigators
Dr Chloé LAURENCIN
Scientific
Hospices Civils De Lyon
Study Sites (1)
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