Status:
RECRUITING
Assessment of 11C-JMJ-129 for Imaging PDE4D in Brain and Whole Body of Healthy Volunteers
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Healthy
Eligibility:
All Genders
18-101 years
Phase:
PHASE1
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 lea...
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. Obje...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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
- EXCLUSION CRITERIA:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
April 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 5 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06874205
Start Date
April 11 2025
End Date
February 5 2029
Last Update
September 5 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892