AzTrials
AzTrials

Parkinson DiseaseNA_PET_MRINCT03942289

Human Aging and in Vivo Noradrenergic System

A study testing The role of the noradrenergic system across the life span (Healthy Subjects) and The role of the noradrenergic system across the life span (Parkinson's Disease Subjects) in people with Parkinson Disease, run by Hospices Civils de Lyon at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson Disease
What is being tested?
The role of the noradrenergic system across the life span (Healthy Subjects) and The role of the noradrenergic system across the life span (Parkinson's Disease Subjects)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
1 siteFrance
Study dates
29 Apr 2019to 29 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Chloé Laurencin, MD contact

4.72.11.80.22 ext. 33

chloe.laurencin@chu-lyon.fr

Bénédicte BALLANGER contact

06.87.90.11.01

benedicte.ballanger@cnrs.fr

France1 site, 1 recruiting

  • Hôpital Neurologique Pierre Wertheimer, Groupement Hospitalier Est

    Bron

    Bénédicte BALLANGER, 06.87.90.11.01, benedicte.ballanger@cnrs.fr

    Recruiting

Other trials in France

About this study

Official title: Investigating the Noradrenergic System in the Living Human Brain With Hybrid Molecular Functional Imaging

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).

Being tested
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)
Keywords
Human, Aging, Behavior, Noradrenergic system, Positron Emission Tomography, Magnetic Resonance Imaging
Medical subject headings
Parkinson Disease, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT03942289
Study groupRoleWhat they receive
Healthy controlsExperimentalNot described
Receives: Other: The role of the noradrenergic system across the life span (Healthy Subjects)
Parkinson diseaseExperimentalNot described
Receives: Other: The role of the noradrenergic system across the life span (Parkinson's Disease Subjects)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1 -180 minutes

Secondary outcomes (14)

  1. 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.

    Measured: Day 2 - 10 minutes

  2. 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.

    Measured: Day 2 - 20 minutes

  3. Working Memory Assessment

    Measured with the Digit Span Memory test. Outcome measure is the total number of items correctly repeated.

    Measured: Day 2 - 20 minutes

  4. 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.

    Measured: Day 2 - 20 minutes

  5. Planning Functioning

    Measured with the Tower of London test. Outcome measure is the total correct and total moves score.

    Measured: Day 2 - 20 minutes

  6. 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)

    Measured: Day 2 - 20 minutes

  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.

    Measured: Day 2 - 10 minutes

  8. 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.

    Measured: Day 2 - 10 minutes

  9. Praxic Abilities

    Measured by the Mahieux Praxic test. Outcome measure is between 0 and 23.

    Measured: Day 2 - 10 minutes

  10. 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.

    Measured: Day 2 - 5 minutes

  11. 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.

    Measured: Day 2 - 5 minutes

  12. 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.

    Measured: Day 2 - 30 minutes

  13. 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.

    Measured: Day 2 - 30 minutes

  14. 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.

    Measured: Day 2 - 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2019
  2. Study start29 Apr 2019
  3. Primary completion29 Jun 2021 (estimated)
  4. Study completion29 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03942289
Sponsor's protocol ID
69HCL18_0409
Other IDs
2018-003999-13, 2018
Acronym
NA_PET_MRI
Status last verified
Jun 2019
First submitted
11 Apr 2019
Last updated
24 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing The role of the noradrenergic system across the life span (Healthy Subjects) and The role of the noradrenergic system across the life span (Parkinson's Disease Subjects) in people with Parkinson Disease, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chloé Laurencin, MD (4.72.11.80.22 ext. 33, chloe.laurencin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) measures (time frame: Day 1 -180 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03942289.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in