First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Dementia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40-75
SponsorDavid Wilson
About this trial
This is a first in human study that will assess the safety and diagnostic performance of \[18F\]RP-115 (fluorine-18 labeled RP115), a positron emission tomography (PET) agent. This agent has the potential to identify the early changes that occur in the brains of patients with Alzheimer's disease (AD) and frontotemporal dementia (FTD).
Eligibility criteria
Qualifiers
Age 40-75
Age-suitable BMI
Ability to provide written informed consent and willingly comply with protocol requirements or has a legal authorized representative/guardian who provides surrogate informed consent.
No apparent physical disorder.
Disqualifiers
Unable to provide written informed consent and unwilling to comply with protocol requirements, or does not have a legal authorized representative/guardian who can provide surrogate informed consent.
Inadequate arterial access.
Receipt of radioisotope < 5 half-lives within [18F]RP-115 imaging- as to not confound any scans with radiation background for previous scanning, and unsuitable organ dosimetry thresholds from previous (> two weeks) PET scans.
The performed [18F]RP-115 scan(s) must not represent > 3 PET studies total within one year.
Trial design
Treatments tested in this trial
- [18F]RP-115 PET/MRI or PET/CT and MRI
Treatment groups
102 Participants
are divided into 4 treatment groupsSponsors and collaborators
David Wilson
Lead sponsor
University of California, San Francisco
Sponsor institution
Rio pharmaceuticals Inc.
Collaborator
Source ClinicalTrials.gov