An interventional study of PET/MRI scanning session and Neuropsychological examination in Healthy Aging and Parkinson's Disease, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science
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).
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 165 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria for the patients with Parkinson's disease:
Exclusion Criteria for all participants :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
120 healthy participants (balanced for sex) ranging from 20 to 80 years old will be included.
Other: PET/MRI scanning session · Behavioral: Neuropsychological examination · Behavioral: Olfactory screening
45 parkinsonian patients with an akineto-rigid phenotype will be included.
Other: PET/MRI scanning session · Behavioral: Neuropsychological examination · Behavioral: Olfactory screening
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.
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.
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.
PET measures
Derived from the PET data, the binding potential (BPND) parametric maps will be calculated using compartmental modelling techniques.
Time frame: 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)
Time frame: Day 1
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.
Time frame: 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.
Time frame: Day 2
Working memory Assessment
Measured with the Digit Span Memory test. Outcome measure is the total number of items correctly repeated.
Time frame: 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.
Time frame: Day 2
Planning Functioning
Measured with the Tower of London test. Outcome measure is the total correct and total moves score.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Day 2
Impulsivity assessment
Measured by the UPPS Impulsive Behavior Scale. Outcome measure is between 0 and 80, higher score indicating severe impulsivity.
Time frame: 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.
Time frame: Day 2
Olfactory assessment: odor threshold
Outcome measure is between 0 and 16,higher score indicating better performance.
Time frame: Day 2
Olfactory assessment: odor discrimination
Outcome measure is between 0 and 16 with higher score indicating better performance.
Time frame: Day 2
Olfactory assessment: odor identification
Outcome measure is between 0 and 16 with higher score indicating better performance.
Time frame: Day 2
Started Jun 2026 (actual). Primary completion is estimated for Sep 2029, 39 months after the start.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 39 months is above that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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