Human Aging and in Vivo Noradrenergic System
NA_PET_MRI
Investigating the Noradrenergic System in the Living Human Brain With Hybrid Molecular Functional Imaging
2 other identifiers
interventional
135
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Apr 2019
Typical duration for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2019
CompletedStudy Start
First participant enrolled
April 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2021
CompletedJune 24, 2019
June 1, 2019
2.2 years
April 11, 2019
June 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (14)
Global Cognitive Assessment
Day 2 - 10 minutes
Memory Assessment
Day 2 - 20 minutes
Working Memory Assessment
Day 2 - 20 minutes
Executive Functioning
Day 2 - 20 minutes
Planning Functioning
Day 2 - 20 minutes
- +9 more secondary outcomes
Study Arms (2)
Healthy controls
EXPERIMENTALParkinson disease
EXPERIMENTALInterventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Neurologique Pierre Wertheimer, Groupement Hospitalier Est
Bron, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chloé Laurencin, MD
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2019
First Posted
May 8, 2019
Study Start
April 29, 2019
Primary Completion
June 29, 2021
Study Completion
June 29, 2021
Last Updated
June 24, 2019
Record last verified: 2019-06