NCT07752784 · Phase 3 · RECRUITING
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.
This trial is testing a radioactive imaging agent called APN-1607, used in PET brain scans, to see how accurately it detects tau tangles — one of the hallmark signs of Alzheimer's — compared to what is found in brain tissue after death. It enrolls people with MCI or Alzheimer's dementia, plus healthy volunteers. This is a Phase 3 trial, meaning the intervention is being evaluated at a larger scale for diagnostic accuracy, not yet approved.
You may qualify if
- 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.
- For MCI or AD subjects: clinically diagnosed as AD-derived cognitive impairment or Alzheimer's dementia.
- For HV subjects: no known personal or family history of AD-derived dementia.
You're excluded if
- 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.
- Suspected hepatic encephalopathy.
- Allergy to the investigational drug or any of its components.
- Currently pregnant or breastfeeding.
- Currently having a disease or condition that prolongs the QT interval.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-08-17