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.
Parallel
[18F]Flortaucipir Injection
DrugA radioactive diagnostic agent intended for brain positron emission tomography (PET) imaging in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD), to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs).
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound
Cmax is defined as the highest observed plasma concentration of total radioactivity (measured by gamma counting) and of the unmetabolized parent \[18F\]Flortaucipir
Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound
Tmax is the time (in minutes) at which the maximum plasma concentration (Cmax) occurs, recorded as the midpoint of the sampling interval during which the maximum is observed.
Terminal Half-Life (t½) of Unmetabolized Parent Compound
Area Under the Plasma Concentration-Time Curve (AUC0-t and AUC0-∞) of Unmetabolized Parent Compound
AUC0-t is calculated using the linear trapezoidal rule from time 0 to the last measurable concentration. AUC0-∞ is extrapolated as AUC0-t + Ct/λz, where Ct is the last quantifiable concentration and λz is the terminal elimination rate constant.
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