Imaging PDE4D in the brain and body using a new radiotracer
Assessment of 11C-JMJ-129 for Imaging PDE4D in Brain and Whole Body of Healthy Volunteers
This study is testing a new imaging tool to see how well it can track a specific protein in the brains and bodies of healthy adults to help us understand its role in brain disorders.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 101 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06874205 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 years and older who meet specific screening criteria.
Not a fit: Patients with current neurological illnesses or significant abnormalities in health assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of PDE4D's involvement in brain disorders, potentially leading to better diagnostic tools.
How similar studies have performed: While this approach is novel, similar imaging studies have shown promise in understanding brain function and disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.