Back to resultsHuman Aging and in Vivo Noradrenergic System (NA_PET_MRI)
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The role of the noradrenergic system across the life span (Healthy Subjects)
The role of the noradrenergic system across the life span (Parkinson's Disease Subjects)
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring Human, Aging, Behavior, Noradrenergic system, Positron Emission Tomography, Magnetic Resonance Imaging
Eligibility Criteria
Inclusion Criteria for the healthy controls:
- Age between 20 years and 80 years
- Weight between 40 kilograms (kg) and 95kg
- Without neurologic or psychiatric history
- Without head trauma history including loss of consciousness superior to 30 minutes.
- Affiliated to a social security or similar scheme
- Not subject to any legal protection measures
- Participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions
Inclusion Criteria for the patients with Parkinson's disease:
- Age between 40 and 80 years old
- Weight between 40 kilograms (kg) and 95kg
- With an idiopathic Parkinson's disease (Dopa-sensitive)
- Without head trauma history including loss of consciousness superior to 30 minutes.
- Affiliated to a social security or similar scheme
- Not subject to any legal protection measures
- Participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions
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
Sites / Locations
- Hôpital Neurologique Pierre Wertheimer, Groupement Hospitalier EstRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy controls
Parkinson disease
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Working Memory Assessment
Measured with the Digit Span Memory test. Outcome measure is the total number of items correctly repeated.
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.
Planning Functioning
Measured with the Tower of London test. Outcome measure is the total correct and total moves score.
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)
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.
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.
Praxic Abilities
Measured by the Mahieux Praxic test. Outcome measure is between 0 and 23.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03942289
Brief Title
Human Aging and in Vivo Noradrenergic System
Acronym
NA_PET_MRI
Official Title
Investigating the Noradrenergic System in the Living Human Brain With Hybrid Molecular Functional Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
June 29, 2021 (Anticipated)
Study Completion Date
June 29, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Human, Aging, Behavior, Noradrenergic system, Positron Emission Tomography, Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy controls
Arm Type
Experimental
Arm Title
Parkinson disease
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
The role of the noradrenergic system across the life span (Healthy Subjects)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The role of the noradrenergic system across the life span (Parkinson's Disease Subjects)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) measures
Description
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.
Time Frame
Day 1 -180 minutes
Secondary Outcome Measure Information:
Title
Global Cognitive Assessment
Description
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 - 10 minutes
Title
Memory Assessment
Description
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 - 20 minutes
Title
Working Memory Assessment
Description
Measured with the Digit Span Memory test. Outcome measure is the total number of items correctly repeated.
Time Frame
Day 2 - 20 minutes
Title
Executive Functioning
Description
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 - 20 minutes
Title
Planning Functioning
Description
Measured with the Tower of London test. Outcome measure is the total correct and total moves score.
Time Frame
Day 2 - 20 minutes
Title
Visuo-spatial Assessment
Description
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)
Time Frame
Day 2 - 20 minutes
Title
Depression Evaluation
Description
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 2 - 10 minutes
Title
Anxiety Evaluation
Description
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 2 - 10 minutes
Title
Praxic Abilities
Description
Measured by the Mahieux Praxic test. Outcome measure is between 0 and 23.
Time Frame
Day 2 - 10 minutes
Title
Day time sleepiness evaluation
Description
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 - 5 minutes
Title
Sleep Quality
Description
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 - 5 minutes
Title
Olfactory assessment : odor detection
Description
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.
Time Frame
Day 2 - 30 minutes
Title
Olfactory assessment: odor discrimination
Description
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.
Time Frame
Day 2 - 30 minutes
Title
Olfactory assessment : odor identification
Description
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.
Time Frame
Day 2 - 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for the healthy controls:
Age between 20 years and 80 years
Weight between 40 kilograms (kg) and 95kg
Without neurologic or psychiatric history
Without head trauma history including loss of consciousness superior to 30 minutes.
Affiliated to a social security or similar scheme
Not subject to any legal protection measures
Participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions
Inclusion Criteria for the patients with Parkinson's disease:
Age between 40 and 80 years old
Weight between 40 kilograms (kg) and 95kg
With an idiopathic Parkinson's disease (Dopa-sensitive)
Without head trauma history including loss of consciousness superior to 30 minutes.
Affiliated to a social security or similar scheme
Not subject to any legal protection measures
Participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chloé Laurencin, MD
Phone
4.72.11.80.22
Ext
33
Email
chloe.laurencin@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Bénédicte BALLANGER
Phone
06.87.90.11.01
Email
benedicte.ballanger@cnrs.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chloé Laurencin, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Neurologique Pierre Wertheimer, Groupement Hospitalier Est
City
Bron
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bénédicte BALLANGER
Phone
06.87.90.11.01
Email
benedicte.ballanger@cnrs.fr
12. IPD Sharing Statement
Learn more about this trial
Human Aging and in Vivo Noradrenergic System
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