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

2026년 7월 7일 업데이트: 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).

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

165

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 프랑스
      • Bron, 프랑스, 69500
        • 모병
        • Hôpital Neurologique Pierre Wertheimer - Service de Neurologie
        • 연락하다:
        • 수석 연구원:
          • Chloé Laurencin, MD/PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Healthy controls
120 healthy participants (balanced for sex) ranging from 20 to 80 years old will be included.
다른: 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.
행동: 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.
행동: 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.
실험적: Parkinson's disease
45 parkinsonian patients with an akineto-rigid phenotype will be included.
다른: 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.
행동: 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.
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
PET measures
기간: Day 1
Derived from the PET data, the binding potential (BPND) parametric maps will be calculated using compartmental modelling techniques.
Day 1
IRM measure
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Global Cognitive Assessment
기간: 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
기간: 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
기간: Day 2
Measured with the Digit Span Memory test. Outcome measure is the total number of items correctly repeated.
Day 2
Executive Functioning
기간: 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
기간: Day 2
Measured with the Tower of London test. Outcome measure is the total correct and total moves score.
Day 2
Verbal fluencies
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Day 2
Outcome measure is between 0 and 16,higher score indicating better performance.
Day 2
Olfactory assessment: odor discrimination
기간: Day 2
Outcome measure is between 0 and 16 with higher score indicating better performance.
Day 2
Olfactory assessment: odor identification
기간: Day 2
Outcome measure is between 0 and 16 with higher score indicating better performance.
Day 2

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hospices Civils de Lyon

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 29일

기본 완료 (추정된)

2029년 9월 1일

연구 완료 (추정된)

2029년 9월 1일

연구 등록 날짜

최초 제출

2026년 4월 28일

QC 기준을 충족하는 최초 제출

2026년 4월 28일

처음 게시됨 (실제)

2026년 5월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 7일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다