Imaging PDE4D in the brain and body using a new radiotracer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the new radiotracer 11C-JMJ-129 for its ability to localize and measure the protein PDE4D in healthy individuals. Participants aged 18 and older will undergo a series of clinic visits that include physical exams, blood tests, and PET imaging scans. The primary objective is to assess the brain uptake of 11C-JMJ-129 and perform kinetic modeling, while secondary objectives include studying the variability, reliability, biodistribution, and radiation dosimetry of the radiotracer. The study will help enhance understanding of PDE4D's role in neurological disorders.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:
* Aged 18 years or older.
* Participants must have undergone a screening assessment under protocol 01-M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants."
* Healthy based on medical history, physical examination, and laboratory testing.
* Able to provide informed consent.
* Willing and able to complete all study procedures including MRI tests.
* Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
* Agree to adhere to the lifestyle considerations

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
* Any current Axis I diagnosis.
* History of neurologic illness or injury with the potential to affect study data interpretation.
* History of seizures, other than in childhood and related to fever.
* Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
* Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
* HIV Infection.
* Pregnancy or breast feeding.
* Participants must not have substance use disorder or alcohol use disorder.
* Unable to travel to the NIH.
* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.

Additional exclusions for participants receiving disulfiram:

Participants will be excluded if any of the following apply:

1. Current use of, or use within the past 14 days, of metronidazole or paraldehyde.
2. Consumption of alcohol or alcohol-containing products within 24 hours prior to disulfiram administration, or inability/unwillingness to abstain from alcohol containing products for 14 days after administration.
3. History or presence of severe myocardial disease or coronary occlusion. Current or past history of psychotic disorders.
4. Known hypersensitivity to disulfiram or other thiuram derivatives.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Robert B Innis, M.D. — National Institute of Mental Health (NIMH)
• Study coordinator: Tara N Turon, C.R.N.P.
• Email: tara.turon@nih.gov
• Phone: (301) 827-6599

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.