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In Vivo Noradrenergic System and Aging (NA2C-PET-MRI)

7 de julho de 2026 atualizado por: Hospices Civils de Lyon

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

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).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

165

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • França
      • Bron, França, 69500
        • Recrutamento
        • Hôpital Neurologique Pierre Wertheimer - Service de Neurologie
        • Contato:
        • Investigador principal:
          • Chloé Laurencin, MD/PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: Healthy controls
120 healthy participants (balanced for sex) ranging from 20 to 80 years old will be included.
Outro: 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., 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.
Comportamental: 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 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.
Comportamental: 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) 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.
Experimental: Parkinson's disease
45 parkinsonian patients with an akineto-rigid phenotype will be included.
Outro: 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., 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.
Comportamental: 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 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.
Comportamental: 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) 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
PET measures
Prazo: Day 1
Derived from the PET data, the binding potential (BPND) parametric maps will be calculated using compartmental modelling techniques.
Day 1
IRM measure
Prazo: Day 1
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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Global Cognitive Assessment
Prazo: Day 2
Measured with Montreal Cognitive Assessment. Outcome measure is between 0 and 30. A score of 26 or over is considered to be normal.
Day 2
Memory Assessment
Prazo: Day 2
Measured with the 16-item Free and Cued Recall test. Outcome measure is the total immediate recall which is the sum of free and cued recall.
Day 2
Working memory Assessment
Prazo: Day 2
Measured with the Digit Span Memory test. Outcome measure is the total number of items correctly repeated.
Day 2
Executive Functioning
Prazo: Day 2
Measured with the Trail Making test. Unit of measure is first seconds to perform the test, which will be converted in a percentile score and then number of errors made during the test.
Day 2
Planning Functioning
Prazo: Day 2
Measured with the Tower of London test. Outcome measure is the total correct and total moves score.
Day 2
Verbal fluencies
Prazo: Day 2
Measured with both the category (semantic fluency) and letter (phonemic fluency) test. Outcome measure is the total number of words generated within 60 sec excluding repetitions
Day 2
Visuo-spatial Assessment
Prazo: Day 2
Measured by the Visual Object and Space Perception Battery. The study will use a selection of theses tests : incomplete letters (outcome measure is between 0 and 20; cut-off score = 16) and number position discrimination (outcome measure is between 0 and 10; cut-off score = 7)
Day 2
Depression Evaluation
Prazo: Day 1
Measured by the Beck Depression Inventory-II Questionnaire. Outcome measure is between 0 and 20 with a cut-off score = 13. A score higher than 14 indicates the presence of depression
Day 1
Anxiety Evaluation
Prazo: Day 1
Measured by the State-Trait Anxiety Inventory (STAI) form Y questionnaire. Outcome measure is between 20 and 80, with higher scores correlating with greater anxiety
Day 1
Day time sleepiness evaluation
Prazo: Day 2
Measured by the Epworth Sleepiness Scale Questionnaire. Outcome measure is between 0 and 24 with a score between 0-8 indicating normal Daytime sleepiness, a score between 9-14 indicating mild sleep deficiency and a score above 15 an excessive daytime sleepiness.
Day 2
Sleep Quality
Prazo: Day 2
Measured by the Pittsburgh Sleep Quality Index (PSQI). Outcome measure is between 0 and 21 with 0 indicating no sleep problem and 21 major sleep disorder.
Day 2
Rapid Eye Movement Behavior disorder
Prazo: Day 2
Measured by the RBDSQ. Outcome measure is between 0 and 10 with 0 indicating no RBD problem and 10 major RBD disorder.
Day 2
Pain Assessment
Prazo: Day 1
Measured by the Visual Analog Pain Scale. Outcome measure is between 0 and 10 with 0 indicating no pain problem and a score higher than 7 an extreme pain.
Day 1
Apathy Assessment
Prazo: Day 2
Measured by the Lille Apathy rating scale. Outcome measure is between -36 to 36 with -36 indicating absence of apathy and 36 severe apathy
Day 2
Fatigue Assessment
Prazo: Day 2
Measured by the Parkinson's disease fatigue Scale (PDFS-16).Outcome measure is between 0 and 80,higher score indicating extreme fatigue.
Day 2
Impulsivity assessment
Prazo: Day 2
Measured by the UPPS Impulsive Behavior Scale. Outcome measure is between 0 and 80, higher score indicating severe impulsivity.
Day 2
Autonomic function
Prazo: Day 2
Measured by the Scales for Outcomes in Parkinson's disease (SCOPA-AUT). Outcome measure is between 0 and 69,higher score indicating presence of autonomic dysfunctions.
Day 2
Olfactory assessment: odor threshold
Prazo: Day 2
Outcome measure is between 0 and 16,higher score indicating better performance.
Day 2
Olfactory assessment: odor discrimination
Prazo: Day 2
Outcome measure is between 0 and 16 with higher score indicating better performance.
Day 2
Olfactory assessment: odor identification
Prazo: Day 2
Outcome measure is between 0 and 16 with higher score indicating better performance.
Day 2

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hospices Civils de Lyon

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

29 de junho de 2026

Conclusão Primária (Estimado)

1 de setembro de 2029

Conclusão do estudo (Estimado)

1 de setembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

28 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de abril de 2026

Primeira postagem (Real)

6 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 69HCL24_1120
  • 2025-524602-15-00 (Ctis)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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