A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy
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).
You may not be if
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.
