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

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).

Conditions

Alzheimer Disease, Frontotemporal Dementia, Dementia

Study Overview

Study Details

Study overview

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).

First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in the Brains of Healthy Controls and Patients With Dementia.

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

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

San Francisco

China Basin, UCSF, San Francisco, California, United States, 94107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.
  • 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.

Ages Eligible for Study

40 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

David Wilson,

David Wilson, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2026-07-01