First Human Study of the PET Tracer 18FRP-115 to Detect Brain Changes in Alzheimers Disease and Frontotemporal Dementia in Adults Aged 40 to 75

What this Trial Is About

Researchers are evaluating a new brain imaging agent called 18FRP-115, a PET tracer targeting the astrocytic glutamate transporter EAAT2, to detect early changes in the brains of people with Alzheimers 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 18FRP-115, followed by brain imaging using PET combined with MRI or PETCT 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 PETCT imaging to evaluate the tracers 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 18FRP-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.

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