| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease | 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) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 135 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Investigating the Noradrenergic System in the Living Human Brain With Hybrid Molecular Functional Imaging |
| Actual Study Start Date : | April 29, 2019 |
| Estimated Primary Completion Date : | June 29, 2021 |
| Estimated Study Completion Date : | June 29, 2021 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Healthy controls |
Other: The role of the noradrenergic system across the life span (Healthy Subjects)
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.
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| Experimental: Parkinson disease |
Other: The role of the noradrenergic system across the life span (Parkinson's Disease Subjects)
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).
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| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for the healthy controls:
Inclusion Criteria for the patients with Parkinson's disease:
Exclusion Criteria:
| Contact: Chloé Laurencin, MD | 4.72.11.80.22 ext 33 | chloe.laurencin@chu-lyon.fr | |
| Contact: Bénédicte BALLANGER | 06.87.90.11.01 | benedicte.ballanger@cnrs.fr |
| France | |
| Hôpital Neurologique Pierre Wertheimer, Groupement Hospitalier Est | Recruiting |
| Bron, France | |
| Contact: Bénédicte BALLANGER 06.87.90.11.01 benedicte.ballanger@cnrs.fr | |
| Principal Investigator: | Chloé Laurencin, MD | Hospices Civils de Lyon |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 11, 2019 | ||||||||
| First Posted Date ICMJE | May 8, 2019 | ||||||||
| Last Update Posted Date | June 24, 2019 | ||||||||
| Actual Study Start Date ICMJE | April 29, 2019 | ||||||||
| Estimated Primary Completion Date | June 29, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) measures [ Time Frame: 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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Human Aging and in Vivo Noradrenergic System | ||||||||
| Official Title ICMJE | Investigating the Noradrenergic System in the Living Human Brain With Hybrid Molecular Functional Imaging | ||||||||
| 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 Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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| Condition ICMJE | Parkinson Disease | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
135 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 29, 2021 | ||||||||
| Estimated Primary Completion Date | June 29, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria for the healthy controls:
Inclusion Criteria for the patients with Parkinson's disease:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03942289 | ||||||||
| Other Study ID Numbers ICMJE | 69HCL18_0409 2018-003999-13 ( EudraCT Number ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Hospices Civils de Lyon | ||||||||
| Study Sponsor ICMJE | Hospices Civils de Lyon | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Hospices Civils de Lyon | ||||||||
| Verification Date | June 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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