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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Objective: To test the new radiotracer 11C-JMJ-129 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 2 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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 101
Healthy Volunteers: t
View:

• 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

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Tara N Turon, C.R.N.P.
tara.turon@nih.gov
(301) 827-6599
Backup
Robert B Innis, M.D.
robert.innis@nih.gov
(301) 594-1368
Time Frame
Start Date: 2025-04-11
Estimated Completion Date: 2029-02-05
Participants
Target number of participants: 40
Treatments
Other: One-arm
All subjects will receive the same tests.
Related Therapeutic Areas
Sponsors
Leads: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov