NCT05374278RecruitingPhase 1/2
First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Dementia
First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in the Brains of Healthy Controls and Patients With Dementia.
Source: ClinicalTrials.gov · Last updated 17 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- First submitted
- 24 Dec 2021
- Start date
- 2 Nov 2021
- Primary completion date
- 3 Apr 2027
- Lead sponsor
- David Wilson
- Diseases
- Frontotemporal dementia, Alzheimer disease
- NCT number
- NCT05374278
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 102
- From 2 Nov 2021 to the primary completion date, 3 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Participants who are pregnant (female patients of childbearing age will be tested prior to injection of tracer- positive test excludes from the study)
Other illness
- 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.
Other
- 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.
- 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 breast-feeding.
Who the study is looking for
- 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.
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China Basin, UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.