A Multicenter Phase III Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection
A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using \[18F\]Fluorbetazine injection.
• 1 1. Men or women aged ≥ 40 years (including the threshold age). 2. Men or women with fertility must use effective contraceptive measures during the study period. Effective contraceptive measures include sterilization, intrauterine hormone devices, condoms, birth control pills, abstinence, or vasectomy.
• 3\. Meet the diagnostic criteria for normal cognitive function, Mild Cognitive Impairment (MCI), or Alzheimer's disease (AD).
• 4\. Participants voluntarily join the study, can cooperate with the experimental observations, and sign a written informed consent form. For participants with AD dementia, the informed consent form must be signed together with their legal guardian. If the participant is unable to sign the informed consent form due to limited cognitive ability or other reasons, the participant's signature space may be left blank, with the reason documented. The guardian should sign in the designated space for explanation.