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NCT07752784
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.
Conditions: Alzheimer's Disease
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 12
Sponsor: JYAMS PET Research & Development Limited
Location: Beijing Tiantan Hospital, Capital Medical University Beijing Beijing Municipality
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07752784). StuddyBuddy aggregates publicly available trial information.