NCT05374278 First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Dementia
| NCT ID | NCT05374278 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | David Wilson |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2021-11-02 |
| Primary Completion | 2027-04-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 102 participants in total. It began in 2021-11-02 with a primary completion date of 2027-04-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Age 40-75 2. Age-suitable BMI 3. Ability to provide written informed consent and willingly comply with protocol requirements or has a legal authorized representative/guardian who provides surrogate informed consent. 4. No apparent physical disorder. 5. Radial, ulnar, or brachial artery suitable for catheterization. 6. Non-smoker, and not taking OTC nicotine cessation - to limit peripheral metabolism events. 7. Devoid of CNS prescription drugs for three weeks - to limit peripheral metabolism events. For Cohort 2B and 2C: 8. 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. 9. Recent (within 6 mo.) MME clinical scores. Exclusion Criteria: 1. 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. 2. Inadequate arterial access. 3. 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. 4. The performed \[18F\]RP-115 scan(s) must not represent \> 3 PET studies total within one year. 5. Contra-indication to magnetic resonance, including permanent pacemaker, implantable metallic device, etc.; or severe claustrophobia. 6. Participants who are pregnant (female patients of childbearing age will be tested prior to injection of tracer- positive test excludes from the study) 7. Participants who are breast-feeding. 8. 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.
Contact & Investigator
David Wilson, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05374278 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05374278 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05374278 currently recruiting?
Yes, NCT05374278 is actively recruiting participants. Contact the research team at david.m.wilson@ucsf.edu for enrollment information.
Where is the NCT05374278 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05374278 clinical trial?
NCT05374278 is sponsored by David Wilson. The principal investigator is David Wilson, MD, PhD at University of California, San Francisco. The trial plans to enroll 102 participants.
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