Clinical Trial

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.

Enrolling by Invitation Phase 3

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.

Protocol Amendment History 3 changes

critical Enrolling by invitation only 2026-08-13

notable Primary completion pushed: 2026-12-31 -> 2027-04-30 2026-08-13

minor Completion pushed: 2027-04-07 -> 2027-08-15 2026-08-13

Trial Details

NCT Number	NCT07752784
Lead Sponsor	JYAMS PET Research & Development Limited
Conditions	Alzheimer's Disease
Enrollment	12 participants
Start Date	2026-08-15
Primary Completion	2027-04-30 (estimated)
Study Completion	2027-08-15 (estimated)
Updated on ClinicalTrials.gov	2026-08-12