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RECRUITING
NCT07853781
PHASE1

First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers

Sponsor: National Institute of Mental Health (NIMH)

View on ClinicalTrials.gov

Summary

Background: PDE4D is a protein found in the brain. It helps control chemical signals that affect mood, memory, and thinking. Problems with PDE4D may play a role in depression and Alzheimer's disease. Being able to measure PDE4D 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 PDE4D 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 1 to 3 business days after their scans.

Key Details

Gender

All

Age Range

18 Years - 105 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-10-26

Completion Date

2031-02-05

Last Updated

2026-10-09

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

[11C]JMJ-129-d2

Injected IV followed by PET scanning

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States