11C-JMJ-129 for Healthy Subjects

Overseen by Robert B Innis, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: National Institute of Mental Health (NIMH)

Disqualifiers: Axis I diagnosis, Neurologic illness, Seizures, HIV, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Robert B Innis, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Eligibility Criteria

This trial is for healthy adults over 18 who've completed a screening under protocol 01-M-0254. It's designed to test a new radiotracer, so participants should be willing to undergo various scans and have no health conditions that exclude them from imaging procedures.

Inclusion Criteria

I am 18 years old or older.

I agree to follow the study's lifestyle requirements.

Healthy based on medical history, physical examination, and laboratory testing

Exclusion Criteria

Pregnancy or breast feeding

History of neurologic illness or injury with the potential to affect study data interpretation

Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging

Participants undergo PET and MRI scans to study the brain uptake of 11C-JMJ-129 and perform kinetic modeling

2-4 visits

2-4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging scans

1 week

Phone call follow-up within 3 days after each PET scan

Treatment Details

Interventions

• 11C-JMJ-129 (Radiotracer)

Trial Overview Researchers are testing the radiotracer 11C-JMJ-129 in healthy volunteers. This substance binds to PDE4D, which is involved in cognitive function and mood disorders. The study involves PET scans of the brain and body, as well as MRI scans of the brain.

Participant Groups

Group I: One-arm Experimental Treatment 1 Intervention

All subjects will receive the same tests.

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH)

Lead Sponsor

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD