NCT05374278 · David Wilson
First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Dementia
What this study is about
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).
View original scientific description
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).
Interventions
DRUG
[18F]RP-115 PET/MRI or PET/CT and MRI
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
Primary outcome measures
Safety of Administered dose
Time frame: A 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-115
Time frame: A 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-115
Time frame: A 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Radial, ulnar, or brachial artery suitable for catheterization.
- Non-smoker, and not taking OTC nicotine cessation - to limit peripheral metabolism events.
- Devoid of CNS prescription drugs for three weeks - to limit peripheral metabolism events. For Cohort 2B and 2C:
- Must have a study partner (informant) who spends a minimum average of 5 hours per week with the participant (e.g. family member, significant other, friend, caregiver), is generally aware of the participant's daily activities, can provide information about the participant's cognitive and functional performance, and will accompany the participant in all study procedure.
- Recent (within 6 mo.) MME clinical scores.
Exclusion criteria
- 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.
- Contra-indication to magnetic resonance, including permanent pacemaker, implantable metallic device, etc.; or severe claustrophobia.
- Participants who are pregnant (female patients of childbearing age will be tested prior to injection of tracer- positive test excludes from the study)
- Participants who are breast-feeding.
- Have a medical condition or other circumstances that in the opinion of the project physicians would significantly decrease chances of obtaining reliable data, achieving the study objective or completing the study.
Where
- San Francisco, California
Collaborators
Rio pharmaceuticals Inc.
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 17, 2025 · Source of record for eligibility and locations