Human Aging and in Vivo Noradrenergic System

NCT ID: NCT03942289

Last Updated: 2019-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-29

Study Completion Date

2021-06-29

Brief Summary

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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).

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy controls

Group Type EXPERIMENTAL

The role of the noradrenergic system across the life span (Healthy Subjects)

Intervention Type 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.

Parkinson disease

Group Type EXPERIMENTAL

The role of the noradrenergic system across the life span (Parkinson's Disease Subjects)

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chloé Laurencin, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hôpital Neurologique Pierre Wertheimer, Groupement Hospitalier Est

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Chloé Laurencin, MD

Role: CONTACT

4.72.11.80.22 ext. 33

Bénédicte BALLANGER

Role: CONTACT

06.87.90.11.01

Facility Contacts

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Bénédicte BALLANGER

Role: primary

06.87.90.11.01

Other Identifiers

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2018-003999-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

69HCL18_0409

Identifier Type: -

Identifier Source: org_study_id

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