First-in-Human Study of [18F]RP-115 PET Tracer in Dementia
This study is testing a new imaging agent called [18F]RP-115. This agent is given through an IV (intravenous) injection and then used with a PET/MRI (positron emission tomography/magnetic resonance imaging) or PET/CT (positron emission tomography/computed tomography) scan. The goal is to see if [18F]RP-115 can safely help doctors identify early brain changes in people with Alzheimer's disease and frontotemporal dementia. Researchers will look at how safe the injection is, how the agent spreads in the body, and how much radiation you receive. You may be able to join if you are between 40 and 75 years old, have a suitable BMI (body mass index), and can give informed consent. The current recruitment status is unclear.
- Study design
- This is a first-in-human interventional study aiming to enroll 102 participants. It is designed to evaluate the safety and performance of a new imaging agent.
- What's involved
- You would receive an IV injection of [18F]RP-115, followed by a PET/MRI or PET/CT and MRI scan. You would need to have a suitable artery for catheterization.
- Compensation
- Not stated in the trial record.
- Follow-up
- The safety, dosimetry, and biodistribution of [18F]RP-115 will be measured for one year after administration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- David Wilson, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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What this trial measures
- Safety of Administered doseA year
Each study participant will undergo a physical examination, vital signs, and ECGs prior to and after the scan and will also be monitored during the scan for adverse events. Additionally, a follow-up with the subject will be conducted 24-48 hours after \[18F\]RP-115 administration. Outcome Measure: Any adverse events will be recorded and graded according to Common Terminology Criteria for Adverse Events.
- Dosimetry of [18F]RP-115A year
Whole-body PET/MRI scan will be conducted immediately after an \[18F\]RP-115 injection and last about 3.5 hours (including breaks) in 8 healthy volunteers (male and female). Equivalent organ radiation doses will be calculated in selected organs using the dynamic PET/MRI data in order to calculate the dosimetry of the tracer. Outcome Measure: Radiation exposure per organ as milliSievert/kg
- Biodistribution of [18F]RP-115A year
Whole-body PET/MRI scan will be conducted immediately after an \[18F\]RP-115 injection and last about 3.5 hours (including breaks) in 8 healthy volunteers (male and female). Percent injected activity (%IA) will be calculated in selected organs using the dynamic PET/MRI data in order to calculate the biodistribution of the tracer. Outcome Measure: Percent injected activity (%Injected radioactivity) in selected organs.