Alzheimer's disease (AD) is the leading cause of dementia and represent a growing public health concern with tremendous impact on patients and their families. Early diagnosis of AD is essential. This study aims to develop a novel radiotracer to fill this unmet need. The excitatory amino acid transporter 2 (EAAT2) is the main transporter for glutamate which is primarily located on the astrocytes and is significantly down-regulated in select cerebral regions of AD brain.~The goal of this study is to test the EAAT2 targeted positron emitting agent, [18F]Fluoro- fluorenylasparaginate methyl ester ([18F]RP-115), to evaluate both safety as well as the early changes in astrocytes in healthy control versus cognitively impaired Alzheimer patients by quantitative PET imaging of EAAT2.~This is a single-center, non-blinded, pilot study. Enrollment of 68 subjects is anticipated. Healthy volunteers will be recruited to determine normal biodistribution of the radiotracer. Alzheimer patients and age-matched controls will be recruited in order to determine the tracer performance. The primary endpoint relates to the safety of the [18F]RP-115 scan. The secondary endpoint relates to acquisition, processing, and comparison of [18F]RP-115 PET data in normal and Alzheimer's diseased brains. The project will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).
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 disease.