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A study using [11C]ORM-13070 to examine the effects of aging and Parkinson's disease on specific brain receptors.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate how normal aging and Parkinson's disease affect the availability of specific receptors in the brain. The research focuses on the noradrenergic system, which is a group of brain cells and chemicals that help regulate various body functions. Specifically, the investigation looks at the alpha2C-adrenergic receptors, which are special proteins in the brain that play a role in how certain messages are sent between nerve cells.

To conduct this research, a substance called [11C]ORM-13070 will be used. This substance is a radiotracer, which is a special compound used to create images of how the body is functioning at a cellular level. This tracer is administered through an injection. The study also utilizes PET and MRI imaging to observe the brain. PET is a method used to visualize biological processes, while MRI is a technique that uses magnetic fields to create detailed pictures of the organs and tissues within the body.

During the study, the brain is examined to look at the locus coeruleus, an area of the brain involved in the noradrenergic system. Researchers will also observe how these brain processes relate to various functions such as memory, language, sleep, and mood. The procedure involves monitoring how the radiotracer interacts with the brain receptors to better understand the changes that occur during aging and in the presence of neurological conditions.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
radiotracer injection
An injection of a radioactive substance called [11C]ORM-13070 is administered. the dose is 350 megabecquerels, which is a unit used to measure radioactivity.
This substance is a radiotracer, which is a special molecule used to visualize specific parts of the brain during imaging.
Step 2
brain imaging
Imaging is performed using two different methods: positron emission tomography (pet) and magnetic resonance imaging (mri).
The pet scan is used to measure the availability of alpha2C-adrenergic receptors, which are proteins in the brain involved in the noradrenergic system. this system helps regulate various bodily functions.
The mri scan is used to look at the locus coeruleus, a specific area in the brain, and to measure neuromelanin, a natural pigment found in certain brain cells.
Step 3
clinical and cognitive assessments
Various tests are conducted to evaluate different functions, including cognition (thinking), memory, language, and visuospatial ability (understanding space and shapes).
Assessments are also performed regarding olfactory function (sense of smell), affective/mood (feelings like apathy, depression, anxiety, fatigue, or impulsivity), sleep patterns, dysautonomia (problems with the autonomic nervous system), and pain levels.

Who can join the trial?

13 criteria

Healthy volunteers must be between 20 and 80 years old.
Healthy volunteers must weigh between 40kg and 100kg.
Healthy volunteers must not have a history of neurological (brain or nervous system) or psychiatric (mental health) conditions.
Healthy volunteers must not have a history of head trauma, which means a physical injury to the head that caused them to pass out or lose consciousness for more than 30 minutes.
Patients with idiopathic Parkinson’s disease, which is a condition that causes movement problems and has no known cause, must be Dopa-sensitive (meaning their symptoms improve when taking the medication Levodopa).
Patients must be between 40 and 80 years old.
Patients must weigh between 40kg and 100kg.
Patients must not have any other neurological pathology, which refers to other diseases or disorders affecting the brain or nervous system.
Patients must not have a history of head trauma, defined as a head injury that caused a loss of consciousness for longer than 30 minutes.
Women of childbearing age must use highly effective contraception, which is a method used to prevent pregnancy.
Participants must be covered by social security or a similar health insurance program.
Participants must not be under any legal protection measures, such as being under a court-ordered guardianship.
All participants must sign an informed consent document, which is a written paper explaining the study details that the person signs to show they agree to join.

Who cannot join the trial?

18 criteria

You are taking, or have taken in the last month, any somatic medication (medicine used to treat physical conditions) that affects the brain or mood, such as antihistamines (medicines often used to treat allergies).
You are currently receiving psychiatric care (medical treatment for mental health conditions).
You are currently living in a health or social care facility for reasons other than participating in research.
You have a current or past dependence (addiction) on alcohol or any addictive substances, though nicotine and caffeine are allowed.
You are currently taking part in another medical research study or have been part of a study that used ionizing radiation (a type of energy, like X-rays, that can pass through the body) within the last year.
You are pregnant, currently giving birth, or breastfeeding.
You have MRI contraindications, which means there are medical reasons why you cannot have a magnetic resonance imaging (MRI) scan, such as:
- Having a pacemaker (a device to control heart rhythm) or an insulin pump (a device to deliver medicine).
- Having metal objects, implanted or embedded (placed inside the body), in your head or body.
- Having claustrophobia (a fear of enclosed or tight spaces).
- Having neurosensory stimulators (devices that help with nerve or sensory functions), implantable defibrillators (devices to help the heart), or cochlear implants (devices to help with hearing).
- Having ferromagnetic (metal that is attracted to magnets) objects in your eyes or near nerve structures in your brain.
- Being unable to cooperate due to agitation (feeling very restless or upset).
- Having a ventriculoperitoneal neurosurgical shunt valve (a device used to drain fluid from the brain).
- Having dental appliances (such as braces or certain types of dental work).
- You have a reason why you cannot have a PET scan (a type of imaging that shows how organs are working), such as an hypersensitivity (an allergic reaction) to the active substance used or to excipients (the inactive ingredients, like salt, used to make the medicine).
- You are unable to understand or complete the study due to reasons like a language barrier or a lack of motivation, as decided by the researcher.
- You do not agree to be told if the doctors find an unexpected medical problem during your MRI or neuropsychological assessment (tests that check how your brain and thinking work).
- You are currently deprived of your liberty by a court or administrative decision.

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Verified sites

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Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France

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Investigated drugs

[11C]ORM-13070 is a specialized substance used as a tracer during brain imaging. It is injected into the body to help researchers see and measure how certain receptors in the brain, specifically those related to the noradrenergic system, are functioning in people with normal aging or Parkinson's disease.

1-[[(3S)-2,3-DIHYDRO-1,4-BENZODIOXIN-3-YL]METHYL]-4-[3-((11C)METHOXYMETHYL)-2-PYRIDINYL]PIPERAZINE

What is already known about the treatment

[11C]ORM-13070 - This substance is a specialized liquid solution administered through an injection into the bloodstream for use during medical imaging scans. Currently used as a research tool in clinical studies, it serves as a way to visualize specific parts of the brain related to the nervous system. It works by traveling through the body and attaching to alpha-2C adrenergic receptors, which are protein targets in the brain that help regulate certain chemical signals. This radiotracer is classified as a PET imaging agent and is primarily used to study how these receptors change in conditions like Parkinson's disease or during the natural aging process.

Investigated diseases

Parkinson's disease - This is a condition that affects the nervous system and primarily impacts movement. It occurs when certain nerve cells in the brain gradually begin to decline or die. As the disease progresses, it can lead to changes in how the brain sends signals to the rest of the body. This often results in difficulties with physical coordination and control. The impact can also extend to various non-movement functions over time.