Assessment of 11C-JMJ-129 for Imaging PDE4D in Brain and Whole Body of Healthy Volunteers

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging tool called 11C-JMJ-129, which helps researchers see a specific protein in the brain and body called PDE4D. This protein is important for understanding conditions like Alzheimer’s disease and depression. The goal of the trial is to see how well this new tool works in healthy volunteers, helping scientists learn more about these disorders.

To take part in the study, you need to be at least 18 years old and healthy based on a medical evaluation. Participants will visit the clinic 2 to 4 times and undergo procedures like blood tests and scans, including a PET scan and an MRI. During these scans, a small amount of a radioactive substance will be injected to help visualize the PDE4D protein. After each scan, participants will receive a health checkup call within three days. This study is a great opportunity for healthy individuals to contribute to important research that could improve our understanding of brain health.

Gender

ALL

Eligibility 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.