First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
National Institute of Mental Health (NIMH)
Summary
Background: PDE-4D is a protein found in the brain. It helps control chemical signals that affect mood, memory, and thinking. Problems with PDE-4D may play a role in depression and Alzheimer disease. Being able to measure PDE-4D levels in the body would help doctors identify and manage these diseases. Researchers want to find out if a new tracer (a radioactive substance injected during imaging scans) can help them see PDE-4D in people more effectively. Objective: To test a new tracer (\[11C\]JMJ-129-d2) during imaging scans of the brain and body in healthy people. Eligibility: Healthy people aged 18 years and older. They must have been screened under protocols 01M0254 or 17M0181. Design: All participants will give samples of blood and urine. They will have a test of their heart function. A plastic tube will be inserted into a vein in their arm; the new tracer will be given through this tube. Some participants will have 1 positron emission tomography (PET)/computed tomography (CT scan of their whole body. They will lie on a padded bed that slides into a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body. Some participants will have 1 or 2 PET/CT scans of their brain only. Their head will be supported to keep it still during the scan. They will also have a magnetic resonance imaging (MRI) scan of the brain. MRI uses magnetic fields to capture images of the inside of the body. The MRI scan may require a second visit. All participants will receive a follow-up call to check on their well-being 2 or 3 days after their scans.
Description
Study Description: This is a Phase 1, first-in-human, single-site, open-label, sequential cohort study designed to evaluate the safety, biodistribution, metabolic stability, and quantitative brain imaging characteristics of the novel positron emission tomography (PET) radioligand \[11C\]JMJ-129-d2 in healthy volunteers. The study will proceed through staged cohorts including whole-body dosimetry, evaluation of brain imaging performance, and test-retest reproducibility. We hypothesize that \[11C\]JMJ-129-d2 will demonstrate acceptable safety, radiation dosimetry typical of 11C-labeled radiolig…
Eligibility
- Age range
- 18–105 years
- Sex
- All
- Healthy volunteers
- No
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent under this protocol. * Successful completion of screening under protocol 01M0254 or 17M0181 and confirmation of eligibility. * Age 18 years or older. * In good general health as determined by medical history, physical examination, vital signs, laboratory testing, and electrocardiogram. * Willingness and ability to comply with all study procedures. * Have had their radial artery pulse checked for the presence of ade…
Interventions
- Drug[11C]JMJ-129-d2
Injected IV followed by PET scanning
Location
- National Institutes of Health Clinical CenterBethesda, Maryland