About this trial
1. To evaluate the diagnostic performance of \[18F\]-APN-1607 injection PET imaging in detecting uptake patterns consistent with AD neuropathological changes as defined by the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. 2. To assess the association between \[18F\]-APN-1607 injection and Alzheimer's disease (AD)-related tau neurofibrillary pathology (as determined by post-mortem brain tissue histopathology), and detect the uptake pattern corresponding to neurofibrillary tangle (NFT) scores. 3. To evaluate the safety of \[18F\]-APN-1607 injection.
Eligibility criteria
Qualifiers
Able to understand and voluntarily sign a written informed consent form (ICF).
Age≥50 years, male or female.
Charlson Comorbidity Index (CCI)≥5.
Able to tolerate imaging procedures.
Disqualifiers
Confirmed brain structural abnormalities that may affect PET reading, e.g., large stroke (infarct area>4 cm) or intracranial space-occupying lesion.
Currently having clinically significant infectious diseases: HIV, hepatitis, etc.
Currently participating in any investigational clinical trial.
Previous participation in clinical studies of amyloid or tau-targeting agents.
Trial design
Treatments tested in this trial
- [18F]-APN-1607