11C-JMJ-129 for Healthy Subjects

Overseen By Robert B Innis, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Mental Health (NIMH)

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new substance, 11C-JMJ-129, which highlights a specific protein in the brain during imaging scans. Researchers aim to learn more about conditions like Alzheimer's and depression by studying this protein. The trial involves healthy volunteers undergoing scans to assess how well the substance reveals protein levels. Individuals who have completed a specific screening and are comfortable with MRI tests might be suitable candidates. Participants will attend a few clinic visits and undergo various scans to gather important data. As a Phase 1 trial, participants will be among the first to help researchers understand how this new substance works in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this radiotracer is safe for use in humans?

Research has shown that 11C-JMJ-129 is a new substance used to visualize a protein called PDE4D in the brain during imaging tests like PET scans. In animal studies, particularly with monkeys, it has effectively targeted PDE4D without affecting other areas, demonstrating precision and effectiveness.

As this trial is in its early stages, it focuses on understanding how the body processes the substance and its safety in humans. The main goal is to identify any immediate side effects. So far, similar early trials and related animal studies have found no major safety issues. This suggests that 11C-JMJ-129 might be safe, but more information from human participants will provide a clearer picture. Researchers will closely monitor participants to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

11C-JMJ-129 is unique because it introduces a novel active ingredient used in imaging to study brain function. Researchers are excited about this treatment due to its potential to provide more detailed and precise images of neurological activity compared to current imaging agents. Unlike standard imaging agents, which may have limitations in specificity and resolution, 11C-JMJ-129 promises to offer clearer insights into brain processes, which can be critical for understanding various neurological conditions.

What evidence suggests that this radiotracer is effective for detecting PDE4D levels?

Research has shown that 11C-JMJ-129, a new substance used in brain scans, attaches to a protein called PDE4D, which relates to thinking and depression. This attachment helps doctors observe PDE4D levels in the brain during scans. Early studies in monkeys demonstrated that 11C-JMJ-129 can successfully highlight PDE4D in the brain. This could aid in studying conditions like Alzheimer's and depression. In this trial, all participants will undergo the same tests to determine if this scanning method provides clear and specific images of PDE4D in humans. ^{1 2 3 6 7}

Who Is on the Research Team?

Robert B Innis, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Are You a Good Fit for This Trial?

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 agree to follow the study's lifestyle requirements.

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

Participants must have undergone a screening assessment under protocol 01-M-0254, 'The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants'

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 11C-JMJ-129

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06874205?locStr=United+States&country=United+States&aggFilters=healthy%3Ay%2Cstatus%3Anot+rec+enr+unk&firstPost=2024-01-01_

Assessment of 11C-JMJ-129 for Imaging PDE4D in Brain ...

They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is ...

2.

jnm.snmjournals.org

jnm.snmjournals.org/content/early/2024/02/29/jnumed.123.266750/tab-figures-data

Robust Quantification of Phosphodiesterase-4D in Monkey ...

(A) VT estimated by Logan analysis of regional monkey brain data for [11C]JMJ-81 and [11C]JMJ-129 at baseline and after PDE4D block with ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11064827/

Robust Quantification of Phosphodiesterase-4D in Monkey ...

This study developed new 11C-labeled PET radioligands for quantifying PDE4D in monkey brain, with [11C]JMJ-81 and [11C]JMJ-129 showing ...

4.

trial.medpath.com

trial.medpath.com/clinical-trial/f5d771d20d578f0e/11c-jmj129-imaging-pde4d-brain-body

Assessment of 11C-JMJ-129 for Imaging PDE4D in Brain and ...

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

5.

withpower.com

withpower.com/trial/phase-1-healthy-subjects-hs-2-2025-a3586

11C-JMJ-129 for Healthy Subjects

This Phase 1 medical study run by National Institute of Mental Health (NIMH) is evaluating whether 11C-JMJ-129 will have tolerable side effects & efficacy ...

6.

trialx.com

trialx.com/clinical-trials/listings/316287/assessment-of-11c-jmj-129-for-imaging-pde4d-in-brain-and-whole-body-of-healthy-volunteers/

Assessment of 11C-JMJ-129 for Imaging PDE4D in Brain ...

To test the new radiotracer 11C-JMJ-129 during imaging scans in healthy volunteers. Eligibility. Healthy people aged 18 years and older who had ...

7.

researchgate.net

researchgate.net/publication/51908027_PET_Measurements_of_cAMP-Mediated_Phosphodiesterase-4_with_R-11CRolipram

PET Measurements of cAMP-Mediated Phosphodiesterase ...

Given the high [ 11 C]JMJ-81 and [ 11 C]JMJ-129 structural similarity, radiometabolite accumulation in monkey brain should also be negligible ...