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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: 11C-JMJ-129

• Registration Number: NCT06874205
• Lead Sponsor: National Institute of Mental Health (NIMH)

Brief 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.

Detailed Description

Study Description:

This study is intended to provide information on the novel 11C-JMJ-129 radioligand and its ability to localize and measure PDE4D in the brain and body of healthy individuals.

Objectives:

Primary Objective: To study the brain uptake of 11C-JMJ-129 and perform kinetic modeling of the 11C-JMJ-129 in healthy individuals.

Secondary Objectives: To study brain retest variability and reliability, biodistribution, and dosimetry of 11C-JMJ-129 in healthy volunteers.

Endpoint:

Primary Endpoint: For both objectives, the primary endpoint is receptor density measured as distribution volume (VT).

Secondary Endpoint: Radiation burden to organs of the body.

Study Timeline

• Status Verified: 2025-03-06
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-13
• Study Start: 2025-04-11
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Primary Completion: 2028-02-22
• Study Completion: 2029-02-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One-arm	11C-JMJ-129	All subjects will receive the same tests.

Primary Outcome Measures

Name	Time	Method
Total Volume of Distribution	120 minutes	Quantification of JMJ129

Secondary Outcome Measures

Name	Time	Method
Dosimetry, ICC, aTRV, and biodistribution.	120 minutes	Quantification of JMJ129

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States