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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.
Sponsor: JYAMS PET Research & Development Limited
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.
Official title: A Clinicopathological Study to Evaluate the Concordance Between [18F]-APN-1607 Injection PET Imaging and Post-mortem Brain Tau Protein Pathological Changes in Cognitively Normal (HV) Subjects and Patients With AD-derived Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) Dementia.
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-08-15
Completion Date
2027-08-15
Last Updated
2026-08-17
Healthy Volunteers
Yes
Conditions
Interventions
[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
Locations (1)
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China