Phase I Study of 18FFlortaucipir PET Imaging to Assess Safety, Body Movement, Radiation Exposure, and Early Diagnostic Results in Chinese Adults Aged 50 to 85

What this Trial Is About

Researchers are conducting a non-randomized, open-label Phase I study in Chinese adults aged 50 to 85 years to evaluate the safety and tolerability of 18FFlortaucipir Injection used during PET scans. This radioactive imaging agent is being studied to understand how it moves through the body, where it accumulates, the amount of radiation exposure it causes, and its preliminary ability to detect signs of Alzheimers disease and mild cognitive impairment. Participants will receive a single injection of 18FFlortaucipir, a radioactive diagnostic agent intended for brain PET imaging to estimate tau protein deposits related to Alzheimers disease. The study includes three groups cognitively normal individuals, those with mild cognitive impairment, and those diagnosed with probable Alzheimers disease, each confirmed by PET and MRI criteria. The study will carefully monitor participants following the injection. During the study, participants will undergo various assessments including PET scans, MRI imaging, blood and urine tests to measure the agents presence and breakdown over time, and safety monitoring for adverse events up to 6 days after injection. Researchers will analyze pharmacokinetics, radiation dosimetry, and diagnostic imaging results to understand the agents behavior and potential diagnostic value. The total duration of participant involvement is relatively short, with close observation immediately following the PET scan.

A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy