Actively Recruiting
Assessment of 11C-JMJ-129 for Imaging PDE4D in Brain and Whole Body of Healthy Volunteers
Led by National Institute of Mental Health (NIMH) · Updated on 2026-05-08
40
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: PDE4D is a protein in the body that plays a role in thinking and depression. This protein may play a major role in disorders such as Alzheimer disease or major depressive disorder. To learn more about these disorders, researchers want to be able to detect levels of PDE4D in the brain. 11C-JMJ-129 is a new radiotracer (a radioactive substance that highlights parts of the body during imaging scans) that was developed to attach only to PDE4D. However, early human studies showed that the tracer may break down in the body and create byproducts that interfere with the brain signal, making the results harder to interpret. This study will test whether a medication called disulfiram can improve PET imaging with 11C-JMJ-129. Disulfiram blocks an enzyme in the body that may be responsible for breaking down the tracer. By reducing this breakdown, the study aims to improve the quality and accuracy of brain images. The results may help researchers better measure PDE4D in the brain and support future studies of brain disorders. Objective: To test the new radiotracer 11C-JMJ-129, with and/or without disulfiram pretreatment during imaging scans in healthy volunteers. Eligibility: Healthy people aged 18 years and older who had a screening assessment under protocol 01-M-0254. Design: Participants will have 1 to 4 clinic visits. Participants will be screened. They will have a physical exam. They will have blood tests and a test of their heart function. Participants will undergo 1 or more of these scans: A positron emission tomography (PET) scan of the whole body. The radiotracer will be injected through a tube placed in a vein in the arm. Participants will lie on a table while a donut-shaped machine passes over them. Blood will be drawn from the arm during this scan. In Phase 5, disulfiram (500 mg orally) will be administered approximately 20 hours before the post-disulfiram PET scan A magnetic resonance imaging (MRI) scan of the brain. Participants will lie on a table that slides into a tube. A PET scan of the brain. These participants will be injected with the radiotracer. They will lie on a table with their head in the scanner. Participants will be called within 3 days after each PET scan for a check on their health.
CONDITIONS
Official Title
Assessment of 11C-JMJ-129 for Imaging PDE4D in Brain and Whole Body of Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older.
- Must have completed a screening assessment under protocol 01-M-0254.
- Healthy based on medical history, physical exam, and lab tests.
- Able to provide informed consent.
- Willing and able to complete all study procedures including MRI tests.
- Have had radial artery pulse checked for adequate ulnar collateral flow.
- No metal or foreign objects in both wrists.
- Agree to adhere to lifestyle considerations.
You will not qualify if you...
- Clinically significant abnormalities on EKG or lab tests including CBC and acute care panel.
- Any current Axis I psychiatric diagnosis.
- History of neurologic illness or injury affecting study data.
- History of seizures except childhood fever-related.
- Recent exposure to radiation exceeding allowable limits.
- Unable to lie flat for at least two hours or claustrophobic or weight over 500 lbs.
- HIV infection.
- Pregnancy or breastfeeding.
- Substance use disorder or alcohol use disorder.
- Unable to travel to NIH.
- Unable to have MRI due to implanted devices, metallic prostheses, shrapnel, or metal fragments.
- For disulfiram use: current or recent use of metronidazole or paraldehyde.
- Consumption of alcohol within 24 hours before disulfiram or unwillingness to abstain for 14 days after.
- History of severe heart disease or psychotic disorders.
- Known allergy to disulfiram or thiuram derivatives.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
T
Tara N Turon, C.R.N.P.
CONTACT
R
Robert B Innis, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here