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.

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorJYAMS PET Research & Development Limited

About this trial

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

Qualifiers

Able to understand and voluntarily sign a written informed consent form (ICF).

Age≥50 years, male or female.

Charlson Comorbidity Index (CCI)≥5.

Able to tolerate imaging procedures.

Disqualifiers

Confirmed brain structural abnormalities that may affect PET reading, e.g., large stroke (infarct area>4 cm) or intracranial space-occupying lesion.

Currently having clinically significant infectious diseases: HIV, hepatitis, etc.

Currently participating in any investigational clinical trial.

Previous participation in clinical studies of amyloid or tau-targeting agents.

Trial design

Treatments tested in this trial

  • [18F]-APN-1607

Treatment groups

12 Participants
are divided into 2 treatment groups