[11C]JMJ-129-d2 for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new tracer, [11C]JMJ-129-d2, which helps doctors visualize a brain protein called PDE4D. This protein is linked to mood, memory, and cognitive issues such as depression and Alzheimer's disease. Researchers aim to find better ways to measure this protein in healthy volunteers using imaging scans. Eligible participants should be in good health and have been screened under specific past protocols. They will undergo imaging scans of the brain and body to assess the tracer's effectiveness. As a Phase 1 trial, this research focuses on understanding how the tracer works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop taking my current medications for the trial?
You may need to stop taking certain medications for this trial. Specifically, you cannot use PDE4 inhibitors or certain other drugs like CYP3A4 inhibitors and inducers within 7 days before the PET imaging.
What prior data suggests that this tracer is safe for use in imaging scans?
Research has shown that [11C]JMJ-129-d2 was safe in early tests. Similar studies and animal research found no major safety issues, suggesting that [11C]JMJ-129-d2 could be safe for humans. The treatment involves a small amount of radiation, commonly used in imaging studies to help doctors visualize certain proteins in the brain. These radiation levels are typical for such studies and are considered safe. Overall, early findings suggest that this treatment is well-tolerated and safe for healthy individuals.12345
Why are researchers excited about this trial?
Researchers are excited about [11C]JMJ-129-d2 because it offers a new way to visualize and understand brain function by targeting specific receptors not previously focused on by standard imaging agents. Unlike traditional imaging agents that may not provide detailed insights into certain neural processes, [11C]JMJ-129-d2 acts on particular molecular targets, potentially offering clearer, more precise brain imaging. This advancement could significantly enhance our understanding of brain activity, paving the way for better diagnostic and therapeutic strategies in the future.
What evidence suggests that this tracer is effective for imaging PDE4D in the brain?
Research has shown that PDE4D is a protein involved in brain functions such as mood, memory, and thinking. Problems with PDE4D may link to depression and Alzheimer's disease. In this trial, all participants will receive [11C]JMJ-129-d2, a new tool designed to visualize PDE4D in the brain through imaging scans. This tool is expected to enhance the detection of PDE4D, potentially aiding in the diagnosis and management of these conditions. Although specific data on the effectiveness of [11C]JMJ-129-d2 is not yet available, it is believed to provide valuable insights into brain health.678910
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 aged 18 and older who have already completed certain screening protocols. Participants must not have any major health issues that would prevent them from safely undergoing imaging scans or receiving the tracer injection.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants undergo PET/CT scans and MRI to evaluate the tracer's imaging properties
Follow-up
Participants receive a follow-up call to check on their well-being after their scans
What Are the Treatments Tested in This Trial?
Interventions
- [11C]JMJ-129-d2
Trial Overview
Researchers are testing a new radioactive tracer called [11C]JMJ-129-d2 to see if it can help visualize a brain protein (PDE-4D) during PET/CT and MRI scans in healthy volunteers. The study involves blood tests, heart checks, and one or more imaging sessions.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All subjects will receive the same tests.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Mental Health (NIMH)
Lead Sponsor
Citations
MIND Diet Intervention to Prevent Alzheimer's Disease
The proposed hybrid diet intervention has demonstrated effects on the prevention and treatment of most of the primary AD risk factors such as hypertension and ...
2.
researchgate.net
researchgate.net/publication/361879968_Healthy_brain_aging_assessed_with_18FFDG_and_11CUCB-J_PETHealthy brain aging assessed with [18F]FDG and [11C ...
We found widespread cortical reduction of synaptic density in a cohort of older HC subjects (N = 15) compared with young HC subjects (N = 11).
Project Details
We have identified a potent activator of the master antioxidant switch and have demonstrated its effectiveness in vitro and in animal models of AD. ... Data ...
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5.
researchgate.net
researchgate.net/publication/317085908_Validation_of_true_low-dose_F-FDG_PET_of_the_brainValidation of true low-dose F-FDG PET of the brain
The purpose of this study was to find a protocol for FDG-PET of the brain with reduced radiation dose and preserved quantitative characteristics. Eight patients ...
6.
trial.medpath.com
trial.medpath.com/clinical-trial/8b7d5f7bba0cea81/nct07853781-11c-jmj-129-d2-pde-4d-imaging-healthy-volunteersFirst-in-Human Evaluation of [11C]JMJ-129-d2 for PDE-4D ...
[11C]JMJ-129-d2 will demonstrate acceptable safety, radiation dosimetry typical of 11C-labeled radioligands, and stable quantitative brain PET ...
Robust Quantification of Phosphodiesterase-4D in ... - PubMed
[11C]JMJ-129 exhibited excellent time stability of signal (total volume of distribution). [11C]JMJ-129 shows a higher PDE4D specific-to- ...
11C-JMJ-129 for Healthy Subjects
So far, similar early trials and related animal studies have found no major safety issues. This suggests that 11C-JMJ-129 might be safe,
Evaluación de [11C]JMJ-129-d2 para la imagen de PDE4D ...
Objetivo del estudio. Este estudio tiene como objetivo evaluar la efectividad de [11C]JMJ-129-d2 para la imagen de PDE4D en voluntarios ...
Quantitative PET Analysis of the Dopamine D 2 Receptor ...
The aim of the present study was to examine the regional distribution and kinetics of 11C-MNPA in the human brain. Ten control subjects were included, and data ...
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