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.
Starting soon · Phase 3
Conditions studied: Alzheimer's Disease
In brief
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 facts
- Study ID
- NCT07752784
- Run by
- JYAMS PET Research & Development Limited
- People needed
- 12
- Starts
- 2026-08-15
- Expected to finish
- 2027-04-07
- Last updated by the study team
- 2026-08-07
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
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 may not qualify 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.
Where it is running
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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