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

Korábbi kezelés

• Major surgery within 1 month prior to screening, or planned surgery during the study period.

Más betegség

• 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).
• 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.

Egyéb

• Pregnant (positive pregnancy test at screening or before administration) or breastfeeding women.
• Inability to tolerate PET/MRI or presence of contraindications to PET/MRI.

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