First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-105
SponsorNational Institute of Mental Health (NIMH)

About this trial

Background:

PDE4D is a protein found in the brain. It helps control chemical signals that affect mood, memory, and thinking. Problems with PDE4D may play a role in depression and Alzheimer's disease. Being able to measure PDE4D levels in the body would help doctors identify and manage these diseases. Researchers want to find out if a new tracer (a radioactive substance injected during imaging scans) can help them see PDE4D in people more effectively.

Objective:

To test a new tracer (\[11C\]JMJ-129-d2) during imaging scans of the brain and body in healthy people.

Eligibility:

Healthy people aged 18 years and older. They must have been screened under protocols 01M0254 or 17M0181.

Design:

All participants will give samples of blood and urine. They will have a test of their heart function. A plastic tube will be inserted into a vein in their arm; the new tracer will be given through this tube.

Some participants will have 1 positron emission tomography (PET)/computed tomography (CT) scan of their whole body. They will lie on a padded bed that slides into a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body.

Some participants will have 1 or 2 PET/CT scans of their brain only. Their head will be supported to keep it still during the scan. They will also have a magnetic resonance imaging (MRI) scan of the brain. MRI uses magnetic fields to capture images of the inside of the body. The MRI scan may require a second visit.

All participants will receive a follow-up call to check on their well-being 1 to 3 business days after their scans.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provision of signed and dated informed consent under this protocol.

Successful completion of screening under protocol 01M0254 or 17M0181 and confirmation of eligibility.

Age 18 years or older.

In good general health as determined by medical history, physical examination, vital signs, laboratory testing, and electrocardiogram.

Disqualifiers

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 DSM-5-TR persistent psychiatric disorder, including but not limited to: schizophrenia spectrum and other psychotic disorders; bipolar and related disorders; and depressive disorders.

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • [11C]JMJ-129-d2

    Drug

    Injected IV followed by PET scanning

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: One-armOther 1 intervention

Trial outcomes

Primary outcomes

1

Total Volume of Distribution

Regional VT from kinetic modeling

Time frame
120 minutes

Secondary outcomes

1

Dosimetry, ICC, aTRV, and biodistribution

Organ residence times and effective dose (rem); regional VT time-stability; test retest variability (TRV) and intraclass correlation coefficient (ICC) of regional VT.

Time frame
120 minutes

Other outcomes

Sponsors and contacts

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