Human Aging and in Vivo Noradrenergic System

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Other: The role of the noradrenergic system across the life span (Healthy Subjects); Other: The role of the noradrenergic system across the life span (Parkinson's Disease Subjects)

• Registration Number: NCT03942289
• Lead Sponsor: Hospices Civils de Lyon

Brief 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 (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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-11
• Study Start: 2019-04-29
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-21
• Last Update Posted: 2019-06-24
• Primary Completion: 2021-06-29
• Study Completion: 2021-06-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Not provided

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Exclusion Criteria

• Subject with alcohol or substance abuse history
• Subject with somatic drug therapies
• Magnetic Resonance Imaging (MRI) contraindications (implanted or embedded metal objects in the head or body)
• Positron Emission Tomography (PET) contraindications
• Exposed to 1 millisievert or more of ionizing radiation in the year before the start of this study
• Subject unable to sign written consent for participation in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	The role of the noradrenergic system across the life span (Healthy Subjects)	-
Parkinson disease	The role of the noradrenergic system across the life span (Parkinson's Disease Subjects)	-

Primary Outcome Measures

Name	Time	Method
Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) measures	Day 1 -180 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Global Cognitive Assessment	Day 2 - 10 minutes	Measured with Montreal Cognitive Assessment. Outcome measure is between 0 and 30. A score of 26 or over is considered to be normal.
Memory Assessment	Day 2 - 20 minutes	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.
Working Memory Assessment	Day 2 - 20 minutes	Measured with the Digit Span Memory test. Outcome measure is the total number of items correctly repeated.
Olfactory assessment : odor detection	Day 2 - 30 minutes	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.
Planning Functioning	Day 2 - 20 minutes	Measured with the Tower of London test. Outcome measure is the total correct and total moves score.
Visuo-spatial Assessment	Day 2 - 20 minutes	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)
Anxiety Evaluation	Day 2 - 10 minutes	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.
Olfactory assessment : odor identification	Day 2 - 30 minutes	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.
Depression Evaluation	Day 2 - 10 minutes	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.
Olfactory assessment: odor discrimination	Day 2 - 30 minutes	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.
Executive Functioning	Day 2 - 20 minutes	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.
Praxic Abilities	Day 2 - 10 minutes	Measured by the Mahieux Praxic test. Outcome measure is between 0 and 23.
Day time sleepiness evaluation	Day 2 - 5 minutes	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.
Sleep Quality	Day 2 - 5 minutes	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.

Trial Locations

Locations (1)

Hôpital Neurologique Pierre Wertheimer, Groupement Hospitalier Est; 🇫🇷 Bron, France