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Human Aging and in Vivo Noradrenergic System (NA_PET_MRI)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Unknown

Conditions

Parkinson Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03942289
69HCL18_0409
2018-003999-13 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

135 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

135 participants in 2 patient groups

Healthy controls
Experimental group
Treatment:
Other: The role of the noradrenergic system across the life span (Healthy Subjects)
Parkinson disease
Experimental group
Treatment:
Other: The role of the noradrenergic system across the life span (Parkinson's Disease Subjects)

Trial contacts and locations

1

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Central trial contact

Bénédicte BALLANGER; Chloé Laurencin, MD

Data sourced from clinicaltrials.gov

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