Evaluate the Concordance Between PET Imaging of [18F]-APN-1607 Injection and Postmortem Brain Tissue Tau Pathology in Individuals With HV and MCI or AD.
[18F]-APN-1607: Participants will receive a single intravenous injection of 5-7 mCi of \[18F\]-APN-1607, and a whole-body PET/CT scan will begin immediately after administration
Study summary
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
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1. Able to understand and voluntarily sign a written informed consent form (ICF).
2. Age≥50 years, male or female.
3. Charlson Comorbidity Index (CCI)≥5.
4. Able to tolerate imaging procedures.
5. For MCI or AD subjects: clinically diagnosed as AD-derived cognitive impairment or Alzheimer's dementia.
6. For HV subjects: no known personal or family history of AD-derived dementia.
Exclusion Criteria:
1. Confirmed brain structural abnormalities that may affect PET reading, e.g., large stroke (infarct area\>4 cm) or intracranial space-occupying lesion.
2. Currently having clinically significant infectious diseases: HIV, hepatitis, etc.
3. Currently participating in any investigational clinical trial.
4. Previous participation in clinical studies of amyloid or tau-targeting agents.
5. Suspected hepatic encephalopathy.
6. Allergy to the investigational drug or any of its components.
7. Currently pregnant or breastfeeding.
8. Currently having a disease or condition that prolongs the QT interval.
Primary outcome measure(s)
Evaluate the consistency between the visual interpretation results of [18F]-APN-1607 injection PET imaging and the authenticity standards. — 8 months Summary of visual reads by 5 blinded readers and concordance analysis between NIA-AA postmortem neuropathology and \[18F\]-APN-1607 PET visual reads.
Trial sites (1)
Facility
City
Region
Status
Beijing Tiantan Hospital, Capital Medical University
Beijing
Beijing Municipality
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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