NCT07752784RecruitingPhase 3
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.
A Clinicopathological Study to Evaluate the Concordance Between [18F]-APN-1607 Injection PET Imaging and Post-mortem Brain Tau Protein Pathological Changes in Cognitively Normal (HV) Subjects and Patients With AD-derived Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) Dementia.
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 29 Jul 2026
- Start date
- 15 Aug 2026
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- JYAMS PET Research & Development Limited
- Diseases
- Alzheimer disease
- NCT number
- NCT07752784
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 12
- From 15 Aug 2026 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in clinical studies of amyloid or tau-targeting agents.
- Allergy to the investigational drug or any of its components.
Other illness
- 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.
Lab values
- Currently having a disease or condition that prolongs the QT interval.
Other
- Currently participating in any investigational clinical trial.
- Suspected hepatic encephalopathy.
- Currently pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.