Healthy Aging and Parkinson's DiseaseNA2C-PET-MRINCT07569120
In Vivo Noradrenergic System and Aging
A study testing PET/MRI scanning session, Neuropsychological examination and Olfactory screening in people with Healthy Aging and Parkinson's Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging and Parkinson's Disease
- What is being tested?
- PET/MRI scanning session, Neuropsychological examination and Olfactory screening
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Neurologique Pierre Wertheimer - Service de Neurologie
Bron, 69500
Chloé Laurencin, MD, PhD, 472118022 ext. +33, chloe.laurencin@chu-lyon.fr
Chloé Laurencin, MD/PhD
About this study
Official title: 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).
- Conditions
- Healthy Aging and Parkinson's Disease
- Being tested
- PET/MRI scanning session, Neuropsychological examination, Olfactory screening
- Keywords
- Noradrenaline, alpha2C, Aging, Parkinson's disease, PET, MRI, Locus Coeruleus, Behavior
- Medical subject headings
- Parkinson Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRI scanning sessionOther
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.
Neuropsychological examinationBehavioural
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.
Olfactory screeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Other | 120 healthy participants (balanced for sex) ranging from 20 to 80 years old will be included. Receives: Other: PET/MRI scanning session; Behavioral: Neuropsychological examination; Behavioral: Olfactory screening |
| Parkinson's disease | Experimental | 45 parkinsonian patients with an akineto-rigid phenotype will be included. Receives: Other: PET/MRI scanning session; Behavioral: Neuropsychological examination; Behavioral: Olfactory screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET measures
Derived from the PET data, the binding potential (BPND) parametric maps will be calculated using compartmental modelling techniques.
Measured: Day 1
IRM measure
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)
Measured: Day 1
Secondary outcomes (20)
Global Cognitive Assessment
Measured with Montreal Cognitive Assessment. Outcome measure is between 0 and 30. A score of 26 or over is considered to be normal.
Measured: Day 2
Memory Assessment
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.
Measured: Day 2
Working memory Assessment
Measured with the Digit Span Memory test. Outcome measure is the total number of items correctly repeated.
Measured: Day 2
Executive Functioning
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.
Measured: Day 2
Planning Functioning
Measured with the Tower of London test. Outcome measure is the total correct and total moves score.
Measured: Day 2
Verbal fluencies
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
Measured: Day 2
Visuo-spatial Assessment
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)
Measured: Day 2
Depression Evaluation
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
Measured: Day 1
Anxiety Evaluation
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
Measured: Day 1
Day time sleepiness evaluation
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.
Measured: Day 2
Sleep Quality
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.
Measured: Day 2
Rapid Eye Movement Behavior disorder
Measured by the RBDSQ. Outcome measure is between 0 and 10 with 0 indicating no RBD problem and 10 major RBD disorder.
Measured: Day 2
Pain Assessment
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.
Measured: Day 1
Apathy Assessment
Measured by the Lille Apathy rating scale. Outcome measure is between -36 to 36 with -36 indicating absence of apathy and 36 severe apathy
Measured: Day 2
Fatigue Assessment
Measured by the Parkinson's disease fatigue Scale (PDFS-16).Outcome measure is between 0 and 80,higher score indicating extreme fatigue.
Measured: Day 2
Impulsivity assessment
Measured by the UPPS Impulsive Behavior Scale. Outcome measure is between 0 and 80, higher score indicating severe impulsivity.
Measured: Day 2
Autonomic function
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.
Measured: Day 2
Olfactory assessment: odor threshold
Outcome measure is between 0 and 16,higher score indicating better performance.
Measured: Day 2
Olfactory assessment: odor discrimination
Outcome measure is between 0 and 16 with higher score indicating better performance.
Measured: Day 2
Olfactory assessment: odor identification
Outcome measure is between 0 and 16 with higher score indicating better performance.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start29 Jun 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Aging and Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569120
- Sponsor's protocol ID
- 69HCL24_1120
- Other IDs
- 2025-524602-15-00, 2025
- Acronym
- NA2C-PET-MRI
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diving Into the in Vivo Noradrenergic System : Role of the alpha2C-adrenergic Receptors
- ClinicalTrials.gov ID
- NCT07569120
- Acronym / sponsor ID
- NA2C-PET-MRI / 69HCL24_1120
- Conditions
- Healthy Aging and Parkinson's Disease
- Keywords
- Noradrenaline, alpha2C, Aging, Parkinson's disease, PET, MRI, Locus Coeruleus, Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Other | Other: PET/MRI scanning session, Behavioral: Neuropsychological examination, Behavioral: Olfactory screening120 healthy participants (balanced for sex) ranging from 20 to 80 years old will be included. |
| Parkinson's disease | Experimental | Other: PET/MRI scanning session, Behavioral: Neuropsychological examination, Behavioral: Olfactory screening45 parkinsonian patients with an akineto-rigid phenotype will be included. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MRI scanning sessionEach 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. | Other | Healthy controls, Parkinson's disease |
| Neuropsychological examinationA 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. | Behavioural | Healthy controls, Parkinson's disease |
| Olfactory screeningAn 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. | Behavioural | Healthy controls, Parkinson's disease |
Primary outcome
PET measures
Time frame: Day 1
Derived from the PET data, the binding potential (BPND) parametric maps will be calculated using compartmental modelling techniques.
IRM measure
Time frame: 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)
20 secondary outcomes
Global Cognitive Assessment
Time frame: Day 2
Memory Assessment
Time frame: Day 2
Working memory Assessment
Time frame: Day 2
Executive Functioning
Time frame: Day 2
Planning Functioning
Time frame: Day 2
Verbal fluencies
Time frame: Day 2
Visuo-spatial Assessment
Time frame: Day 2
Depression Evaluation
Time frame: Day 1
Anxiety Evaluation
Time frame: Day 1
Day time sleepiness evaluation
Time frame: Day 2
Sleep Quality
Time frame: Day 2
Rapid Eye Movement Behavior disorder
Time frame: Day 2
Pain Assessment
Time frame: Day 1
Apathy Assessment
Time frame: Day 2
Fatigue Assessment
Time frame: Day 2
Impulsivity assessment
Time frame: Day 2
Autonomic function
Time frame: Day 2
Olfactory assessment: odor threshold
Time frame: Day 2
Olfactory assessment: odor discrimination
Time frame: Day 2
Olfactory assessment: odor identification
Time frame: Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MRI scanning session, Neuropsychological examination and Olfactory screening in people with Healthy Aging and Parkinson's Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chloé Laurencin, MD / PhD (472118022 ext. +33, chloe.laurencin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET measures (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.