In Vivo Noradrenergic System and Aging

Официальное название

Diving Into the in Vivo Noradrenergic System : Role of the alpha2C-adrenergic Receptors

Обзор

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).

Вмешательства

• Другое PET/MRI scanning session
  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.
• Поведенческое Neuropsychological examination
  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
• Поведенческое Olfactory screening
  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) t

Первичные конечные точки

• PET measures [Срок оценки: Day 1]
• IRM measure [Срок оценки: Day 1]

Вторичные конечные точки (12)

• Global Cognitive Assessment [Срок оценки: Day 2]
• Memory Assessment [Срок оценки: Day 2]
• Working memory Assessment [Срок оценки: Day 2]
• Executive Functioning [Срок оценки: Day 2]
• Planning Functioning [Срок оценки: Day 2]
• Verbal fluencies [Срок оценки: Day 2]
• Visuo-spatial Assessment [Срок оценки: Day 2]
• Depression Evaluation [Срок оценки: Day 1]
• Anxiety Evaluation [Срок оценки: Day 1]
• Day time sleepiness evaluation [Срок оценки: Day 2]
• Sleep Quality [Срок оценки: Day 2]
• Rapid Eye Movement Behavior disorder [Срок оценки: Day 2]

Критерии участия

Inclusion Criteria for the healthy controls:

• 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

Inclusion Criteria for the patients with Parkinson's disease:

• 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
• Not subject to any legal protection measures
• Participant must have signed an informed consent document

Exclusion Criteria for all participants :

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Hôpital Neurologique Pierre Wertheimer - Service de Neurologie — Bron

Идентификаторы

NCT: NCT07569120 · 69HCL24_1120 · 2025-524602-15-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗