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
Study ID
NCT07752784
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • [18F]-APN-1607 — DRUG
    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 Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 15, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cognitively Normal (HV)
    Cognitively Normal will undergo PET imaging using \[18F\]-APN-1607
  • Experimental: Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)
    Alzheimer's Disease or Mild Cognitive Impairment subjects will undergo PET imaging using \[18F\]-APN-1607

Primary Outcome Measure

Evaluate the consistency between the visual interpretation results of [18F]-APN-1607 injection PET imaging and the authenticity standards. [ Time Frame: 8 months ]

Central Contacts

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