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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003999-13 | EudraCT Number |
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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 (Parkinson's disease) through the use of a newly developed radiotracer (11Carbon [11C]Yohimbine) visualizing alpha-2 (α2) adrenergic receptors (AR) combined with cutting-edge technology, the hybrid positron emission tomography (PET)/magnetic resonance imaging (MRI) scanner. The secondary aim of this study will be to determine whether the expected age- and Parkinson's disease (PD)-related changes in the noradrenergic system are paralleled by changes in neuropsychological performances (such as cognitive, motor and/or olfactory abilities).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy controls | Experimental |
| |
| Parkinson disease | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The role of the noradrenergic system across the life span (Healthy Subjects) | Other | A sample (n=90) of balanced distribution of healthy males and females within a continuous segment of the adult life span from 20 to 80 years old will be recruited, with approximately 7 males and 7 females subjects for each decade of age. Each participant will undergo 1) a neuropsychological examination, 2) an olfactory screening and 3) a 90 min 11C-Yohimbine positron emission tomography (PET)/magnetic resonance imaging (MRI) scan in a resting state. |
| Measure | Description | Time Frame |
|---|---|---|
| Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) measures | Derived from the Positron Emission Tomography (PET) data, the binding potentials will be calculated using compartmental modelling techniques. Derived from the Magnetic Resonance Imaging (MRI) data. | Day 1 -180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 2 - 10 minutes |
| Memory Assessment |
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Inclusion Criteria for the healthy controls:
Inclusion Criteria for the patients with Parkinson's disease:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chloé Laurencin, MD | Contact | 4.72.11.80.22 | 33 | chloe.laurencin@chu-lyon.fr |
| Bénédicte BALLANGER | Contact | 06.87.90.11.01 | benedicte.ballanger@cnrs.fr |
| Name | Affiliation | Role |
|---|---|---|
| Chloé Laurencin, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Neurologique Pierre Wertheimer, Groupement Hospitalier Est | Recruiting | Bron | France |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| The role of the noradrenergic system across the life span (Parkinson's Disease Subjects) | Other | Three groups of Parkinson Disease (PD) patients (each of them n=15) will be studied according to the duration and stage of the disease: early stage (the same group in Task 2); mid stage (5-7 years of disease duration; Hoehn and Yahr in Off 2-3); late stage (7-10 years of disease duration; Hoehn and Yahr in Off 3-4). |
|
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 - 20 minutes |
| Working Memory Assessment | Measured with the Digit Span Memory test. Outcome measure is the total number of items correctly repeated. | Day 2 - 20 minutes |
| 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. | Day 2 - 20 minutes |
| Planning Functioning | Measured with the Tower of London test. Outcome measure is the total correct and total moves score. | Day 2 - 20 minutes |
| 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 position discrimination (outcome measure is between 0 and 10; cut-off score = 7) | Day 2 - 20 minutes |
| 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. | Day 2 - 10 minutes |
| 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. | Day 2 - 10 minutes |
| Praxic Abilities | Measured by the Mahieux Praxic test. Outcome measure is between 0 and 23. | Day 2 - 10 minutes |
| 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. | Day 2 - 5 minutes |
| 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. | Day 2 - 5 minutes |
| Olfactory assessment : odor detection | The odor detection capability will be evaluated using a phenyl-ethyl alcohol (PEA) test. In this experiment, the detection threshold is obtained using a "staircase" procedure. Outcome measure is between 0 and 16 with higher score indicating better performance. | Day 2 - 30 minutes |
| Olfactory assessment: odor discrimination | Odor discrimination capacity will be assessed by asking the participant to smell three bottles (two bottles contain the same odor, and the third contains a different smell). The test includes 16 triplets of odorous substances. Outcome measure is between 0 and 16 with higher score indicating better performance. | Day 2 - 30 minutes |
| Olfactory assessment : odor identification | The odor identification capacity will be estimated by the European test of olfactory capacities (ETOC), a test based on 16 identifications. Outcome measure is between 0 and 16 with higher score indicating better performance. | Day 2 - 30 minutes |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |