This is a non randomized, open-label Phase I study in Chinese participants. The goal of this clinical trial is to evaluate the safety and tolerability of a radioactive imaging agent called \[18F\]Flortaucipir Injection, which is used during a PET scan. The study will also measure how the agent moves through the body (pharmacokinetics), where it goes (biodistribution), the amount of radiation exposure (radiation dosimetry), and how well it may help detect signs of disease (preliminary diagnostic efficacy).
Signed informed consent form (ICF).
Male or female aged 50-85 years.
Education level sufficient to cooperate with neuropsychological testing and obtain reliable results.
CN: No history of cognitive impairment, Aβ-PET negative, MRI without clinically significant neurodegenerative changes.
Pregnant (positive pregnancy test at screening or before administration) or breastfeeding women.
Major surgery within 1 month prior to screening, or planned surgery during the study period.
Known allergy to radioactive radiation, alcohol, [18F]Flortaucipir injection, or its excipients, or other severe allergic reactions.
Cognitive impairment due to causes other than AD.