NCT07686393 PET Imaging of Noradrenergic Transmission in the Brain
| NCT ID | NCT07686393 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Institute of Mental Health (NIMH) |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-07-23 |
| Primary Completion | 2029-02-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2026-07-23 with a primary completion date of 2029-02-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Researchers have developed a new radioactive tracer (11C-ARMI). A tracer is a drug that attaches itself to other chemicals in the body and lights up so that the chemicals can be seen in imaging scans. The new tracer may be able to help them with many diseases, such as Alzheimer s disease and Parkinson s disease. Researchers want to test the new tracer in healthy people. Objective: To test a new tracer (11C-ARMI) 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 01-M-0254 or 17M0181. Design: All participants will have a positron emission tomography (PET)/computed tomography (CT) scan. Before the scan, they will have blood and urine tests and a test of their heart function. The tracer will be given through a tube attached to a needle inserted into a vein in the arm. They will lie on a padded bed that fits inside a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body. Some participants will have a PET/CT scan of their whole body. They will need only 1 visit. Some participants will have a PET/CT scan of only their brain. They will have up to 2 visits. On the second visit, they will have a magnetic resonance imaging (MRI) scan of the brain. For the MRI, they will lie on a table that slides into a cylinder. The MRI uses magnetic fields to create images of the inside of the body. Participants will receive a follow-up call to check on their well-being after their PET/CT scans.
Eligibility Criteria
* INCLUSION CRITERIA: 1. Aged 18 years or older. 2. Must have undergone a screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants or 17M0181 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies. 3. Be healthy based on medical history, physical examination, and laboratory testing. 4. Able to understand and willingness to provide informed consent. 5. Willingness to complete all study procedures including MRI tests. 6. 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. 7. 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: 1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). 2. Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits. 3. 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). 4. HIV infection. 5. Pregnancy or breastfeeding. 6. Must not have substance use disorder or alcohol use disorder. 7. Unable to travel to the NIH. 8. 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. 9. Taking medications reported to have significant binding to alpha-1 adrenoceptors, medications that that alter norepinephrine release, or medications that lower blood pressure including antihypertensives, diuretics, or phosphodiesterase-5(PDE-5) inhibitors (e.g. sildenafil, tadalafil, vardenafil) within five elimination halflives prior to any \[11C\]ARMI PET scan. 10. Known hypersensitivity to quinazoline-class medications (e.g., prazosin), defined as any prior allergic or clinically significant adverse reaction requiring discontinuation or medical evaluation. 11. Blood donation within 8 weeks (2 months) before study participation, or unwillingness to avoid blood donation for 8 weeks (2 months) after the study.
Contact & Investigator
Robert B Innis, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Mental Health (NIMH)
Frequently Asked Questions
Who can join the NCT07686393 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 105 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07686393 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07686393 currently recruiting?
Yes, NCT07686393 is actively recruiting participants. Contact the research team at tara.turon@nih.gov for enrollment information.
Where is the NCT07686393 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT07686393 clinical trial?
NCT07686393 is sponsored by National Institute of Mental Health (NIMH). The principal investigator is Robert B Innis, M.D. at National Institute of Mental Health (NIMH). The trial plans to enroll 40 participants.