1-[[(3S)-2,3-DIHYDRO-1,4-BENZODIOXIN-3-YL]METHYL]-4-[3-((11C)METHOXYMETHYL)-2-PYRIDINYL]PIPERAZINE for Parkinson's disease | Normal aging

Inclusion criteria

• {"criterion_text":"- Healthy volunteers : Age between 20 years and 80 years\n- Patients : Weight between 40kg and 100kg\n- Patients : With an idiopathic Parkinson’s disease (Dopa-sensitive)\n- Patients : Without head trauma history including loss of consciousness superior to 30 minutes\n- Patients : Without associated neurological pathology\n- Patients : With highly effective contraception for women of childbearing age\n- Patients : Affiliated to a social security or similar scheme\n- Patients : Not subject to any legal protection measures\n- Patients : Participant must have signed an informed consent document\n- Healthy volunteers : Weight between 40kg and 100kg\n- Healthy volunteers : Without neurologic or psychiatric history\n- Healthy volunteers : Without head trauma history including loss of consciousness superior to 30 minutes\n- Healthy volunteers : With highly effective contraception for women of childbearing age\n- Healthy volunteers : Affiliated to a social security or similar scheme\n- Healthy volunteers : Not subject to any legal protection measures\n- Healthy volunteers : Participant must have signed an informed consent document\n- Patients : Age between 40 years and 80 years"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"BPND will be estimated from PET data using compartmental modelling techniques (SRTM referenced in translations) with the cerebellum as reference region; LC will be defined on MRI using a semi-automatic neuromelanin-sensitive sequence and its signal intensity (LC/pons contrast ratio) calculated per participant."}

Secondary endpoints

• {"endpoint_text":"- Correlation coefficients between regional BPND and contrast ratio in the LC (signal intensity).","definition_or_measurement_approach":"Statistical correlation coefficients between regional PET-derived BPND values and MRI-derived LC contrast ratio (signal intensity)."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Correlation analyses between α₂C BPND and LC contrast ratio and a battery of clinical/neuropsychological tests listed (MoCA, TMT A/B, Stroop, RL/RI-16, digit span, verbal fluency, VOSP, Sniffin' Sticks TDI, LARS, BDI-II, STAI, PDFS-16, UPPS, Epworth, RBDSQ, SCOPA-AUT, EVA)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Correlation analyses between PET-MRI indices (α₂C BPND and LC contrast ratio) and clinical/behavioral variables including disease severity and the listed functional domains."}

France

Earliest CTIS Part Ii Submission Date

05-03-2026

Latest Decision Or Authorization Date

24-04-2026

Processing Time Days

50

Number Of Sites

1

Number Of Participants

165

Primary sponsor

Full Name

Hospices Civils De Lyon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"ANR 2025","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Association France Parkinson","duties_or_roles":"Source of monetary support","organisation_type":""}