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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.

RecruitingPhase 3Ages 50 Years - anyAllJYAMS PET Research & Development Limited
NCT07752784 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • [18F]-APN-1607
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Where

1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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