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

A Non Randomized, Open-Label Phase I Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry, and Preliminary Diagnostic Efficacy of [18F]Flortaucipir Injection PET Imaging in Chinese Subjects

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).

Inclusion Criteria:

• Signed informed consent form (ICF).

• Male or female aged 50-85 years.

• Education level sufficient to cooperate with neuropsychological testing and obtain reliable results.

• Meet the following criteria related to cognitive impairment:

  1. CN: No history of cognitive impairment, Aβ-PET negative, MRI without clinically significant neurodegenerative changes.
  2. MCI: Meet core criteria for AD-related MCI, Aβ-PET positive, MRI showing neurodegenerative changes.
  3. AD: Meet core criteria for probable AD dementia, Aβ-PET positive, MRI showing neurodegenerative changes.

• Fertile individuals: No plan for reproduction, sperm/egg donation within 6 months after signing ICF and until 6 months after study drug administration; and agreement to use highly effective contraception (including partner).

Exclusion Criteria:

• 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.
• Clinically significant infarction or probable multi-infarct dementia.
• Current clinically significant psychiatric illness (e.g., major depression, schizophrenia).
• History of epilepsy or seizures (except febrile seizures in childhood).
• Inability to tolerate PET/MRI or presence of contraindications to PET/MRI.
• Other neurodegenerative diseases or dementias other than AD dementia.
• Any other condition that, in the investigator's opinion, makes the subject unsuitable for the study.