HealthyPhase 1NCT06874205
Assessment of 11C-JMJ-129 for Imaging PDE4D in Brain and Whole Body of Healthy Volunteers
A Phase 1 study testing 11C-JMJ-129 in people with Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 101 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 11C-JMJ-129
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2025to 5 Feb 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 101 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
- Any current Axis I diagnosis.
- History of neurologic illness or injury with the potential to affect study data interpretation.
- History of seizures, other than in childhood and related to fever.
- Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
Show all 18Show fewer
- Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
- HIV Infection.
- Pregnancy or breast feeding.
- Participants must not have substance use disorder or alcohol use disorder.
- Unable to travel to the NIH.
- Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.
- Additional exclusions for participants receiving disulfiram:
- Participants will be excluded if any of the following apply:
- Current use of, or use within the past 14 days, of metronidazole or paraldehyde.
- Consumption of alcohol or alcohol-containing products within 24 hours prior to disulfiram administration, or inability/unwillingness to abstain from alcohol containing products for 14 days after administration.
- History or presence of severe myocardial disease or coronary occlusion. Current or past history of psychotic disorders.
- Known hypersensitivity to disulfiram or other thiuram derivatives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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. However, early human studies showed that the tracer may break down in the body and create byproducts that interfere with the brain signal, making the results harder to interpret. This study will test whether a medication called disulfiram can improve PET imaging with 11C-JMJ-129. Disulfiram blocks an enzyme in the body that may be responsible for breaking down the tracer. By reducing this breakdown, the study aims to improve the quality and accuracy of brain images. The results may help researchers better measure PDE4D in the brain and support future studies of brain disorders.
Read more
Objective:
To test the new radiotracer 11C-JMJ-129, with and/or without disulfiram pretreatment 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 1 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.
In Phase 5, disulfiram (500 mg orally) will be administered approximately 20 hours before the post-disulfiram PET 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- 11C-JMJ-129
- Keywords
- 11C-JMJ-129, PET Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-JMJ-129Drug
Injected IV followed by PET scanning
| Study group | Role | What they receive |
|---|---|---|
| One-arm | Other | All subjects will receive the same tests. Receives: Drug: 11C-JMJ-129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Volume of Distribution
Quantification of JMJ129
Measured: 120 minutes
Secondary outcomes (1)
Dosimetry, ICC, aTRV, and biodistribution.
Quantification of JMJ129
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start11 Apr 2025
- Primary completion22 Feb 2028 (estimated)
- Study completion5 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert B Innis, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874205
- Sponsor's protocol ID
- 10001777
- Other IDs
- 001777-M
- Status last verified
- 14 Aug 2026
- First submitted
- 12 Mar 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be submitted to ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of 11C-JMJ-129 for Imaging PDE4D in Brain and Whole Body of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06874205
- Acronym / sponsor ID
- 10001777
- Conditions
- Healthy
- Keywords
- 11C-JMJ-129, PET Imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 22 Feb 2028 (estimated)
- Study completion
- 5 Feb 2029 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. However, early human studies showed that the tracer may break down in the body and create byproducts that interfere with the brain signal, making the results harder to interpret. This study will test whether a medication called disulfiram can improve PET imaging with 11C-JMJ-129. Disulfiram blocks an enzyme in the body that may be responsible for breaking down the tracer. By reducing this breakdown, the study aims to improve the quality and accuracy of brain images. The results may help researchers better measure PDE4D in the brain and support future studies of brain disorders.
Objective:
To test the new radiotracer 11C-JMJ-129, with and/or without disulfiram pretreatment 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 1 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.
In Phase 5, disulfiram (500 mg orally) will be administered approximately 20 hours before the post-disulfiram PET 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One-arm | Other | Drug: 11C-JMJ-129All subjects will receive the same tests. |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
- Any current Axis I diagnosis.
- History of neurologic illness or injury with the potential to affect study data interpretation.
- History of seizures, other than in childhood and related to fever.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 11C-JMJ-129Injected IV followed by PET scanning | Drug | One-arm |
Primary outcome
Total Volume of Distribution
Time frame: 120 minutes
Quantification of JMJ129
1 secondary outcome
Dosimetry, ICC, aTRV, and biodistribution.
Time frame: 120 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The results will be submitted to ClinicalTrials.gov
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert B Innis, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 11C-JMJ-129 in people with Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tara N Turon, C.R.N.P. ((301) 827-6599, tara.turon@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Volume of Distribution (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.