Health TrialsbyHealthPanel

First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Dementia

ConditionsAlzheimer DiseaseFrontotemporal DementiaDementia
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • [18F]RP-115 PET/MRI or PET/CT and MRI

    Drug

    An I.V. bolus injection of up to 10 millicurie (mCi) \[18F\]RP-115 will be administered, followed by a PET/MRI scan or by a combination of PET/CT and MRI

Treatment groups

102 Participants
are divided into 4 treatment groups
Group A: Cohort 1 - dosimetry of [18F]RP-115 in healthy volunteersExperimental treatment 1 intervention
Group B: Cohort 2B - [18F]RP-115 in patients with ADExperimental treatment 1 intervention
Group C: Cohort 2C - [18F]RP-115 in patients with FTDExperimental treatment 1 intervention
Group D: Cohort 2A - [18F]RP-115 in age-matched controlsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of Administered dose

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.

Time frame
A year
2

Dosimetry of [18F]RP-115

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

Time frame
A year
3

Biodistribution of [18F]RP-115

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.

Time frame
A year

Secondary outcomes

1

[18F]RP-115 diagnostic performance

Utilize RP-115 to quantitatively assess regional cerebral RP-115 binding differences in healthy volunteers compared to cognitively-defined AD and FTD. Outcome Measure: Radioactivity distribution volume across cerebral cortex, Becquerel/mL or standardized uptake value.

Time frame
Three years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Wilson

Lead sponsor

University of California, San Francisco

Sponsor institution

Rio pharmaceuticals Inc.

Collaborator

Source ClinicalTrials.gov
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