Actively Recruiting

Phase 1
Phase 2
Age: 40Years - 75Years
All Genders
Healthy Volunteers
ID05374278

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

Led by David Wilson · Updated on 2025-04-17

102

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

D

David Wilson

Lead Sponsor

R

Rio pharmaceuticals Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new brain imaging agent called [18F]RP-115, a PET tracer targeting the astrocytic glutamate transporter EAAT2, to detect early changes in the brains of people with Alzheimer's disease (AD) and frontotemporal dementia (FTD). Both AD and FTD are leading causes of dementia and early diagnosis is important for improving quality of life and treatment development. This study aims to assess the safety and diagnostic performance of this tracer in humans for the first time. Participants will receive an intravenous injection of up to 10 millicurie of [18F]RP-115, followed by brain imaging using PET combined with MRI or PET/CT and MRI. The study includes several groups: healthy volunteers, patients with AD, patients with FTD, and age-matched cognitively normal controls. The goal is to measure how the tracer distributes in the body and binds in the brain regions affected by these dementias. During the study, participants undergo PET scans along with MRI or PET/CT imaging to evaluate the tracer's biodistribution and safety. Cognitive assessments and clinical evaluations are collected for dementia patients. The main outcomes include safety of the dose, dosimetry, biodistribution, and diagnostic accuracy of [18F]RP-115 over up to one year, with secondary evaluations extending to three years. Participants may be followed and monitored throughout this period to help researchers understand how well the tracer works in detecting early brain changes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 40 and 75 years
  • Age-appropriate body mass index (BMI)
  • Ability to provide written informed consent or have a legal guardian who can provide consent
  • No apparent physical disorder
  • Suitable radial, ulnar, or brachial artery for catheterization
  • Non-smoker and not using over-the-counter nicotine cessation products
  • No central nervous system prescription drugs for at least three weeks
  • For Alzheimer's and frontotemporal dementia patients: must have a study partner who spends at least 5 hours per week with the participant and can provide information about cognitive and functional performance
  • Recent clinical cognitive scores within 6 months for dementia patients
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent or unwilling to comply with study protocol
  • Inadequate arterial access
  • Recent receipt of radioisotope within 5 half-lives before imaging
  • More than 3 PET studies within one year
  • Contraindications to MRI, such as pacemaker or metal implants, or severe claustrophobia
  • Pregnancy or positive pregnancy test prior to tracer injection
  • Breast-feeding
  • Any medical condition or circumstance judged by the study physicians to interfere with obtaining reliable data or completing the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants receive an intravenous injection of the PET tracer [18F]RP-115, followed by PET/MRI or PET/CT and MRI scans to evaluate brain changes related to dementia.

1 imaging visit (in-person)

Long-term Monitoring

Duration - Up to 3 years

Participants are monitored for safety and to measure tracer biodistribution and diagnostic performance over time.

Follow-up visits as needed

Trial Site Locations

Total: 1 location

1

China Basin, UCSF

San Francisco, California, United States, 94107

Actively Recruiting

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Research Team

D

David Wilson, MD, PhD

H

Henry Vanbrocklin, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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Published Research Related To This Trial

Comparison of Early-Phase 11C-Deuterium-l-Deprenyl and 11C-Pittsburgh Compound B PET for Assessing Brain Perfusion in Alzheimer Disease.

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https://pubmed.ncbi.nlm.nih.gov/26912447

Altered expression of glutamate transporter-1 and water channel protein aquaporin-4 in human temporal cortex with Alzheimer's disease.

A Hoshi, A Tsunoda, T Yamamoto...

https://pubmed.ncbi.nlm.nih.gov/29405337