NCT07752784 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.
| NCT ID | NCT07752784 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | JYAMS PET Research & Development Limited |
| Condition | Alzheimer's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-08-15 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 12 participants in total. It began in 2026-08-15 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Able to understand and voluntarily sign a written informed consent form (ICF). 2. Age≥50 years, male or female. 3. Charlson Comorbidity Index (CCI)≥5. 4. Able to tolerate imaging procedures. 5. For MCI or AD subjects: clinically diagnosed as AD-derived cognitive impairment or Alzheimer's dementia. 6. For HV subjects: no known personal or family history of AD-derived dementia. Exclusion Criteria: 1. Confirmed brain structural abnormalities that may affect PET reading, e.g., large stroke (infarct area\>4 cm) or intracranial space-occupying lesion. 2. Currently having clinically significant infectious diseases: HIV, hepatitis, etc. 3. Currently participating in any investigational clinical trial. 4. Previous participation in clinical studies of amyloid or tau-targeting agents. 5. Suspected hepatic encephalopathy. 6. Allergy to the investigational drug or any of its components. 7. Currently pregnant or breastfeeding. 8. Currently having a disease or condition that prolongs the QT interval.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07752784 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Alzheimer's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07752784 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 12 participants.
Is NCT07752784 currently recruiting?
Yes, NCT07752784 is actively recruiting participants. Contact the research team at tangqian@pet-tracer.com.cn for enrollment information.
Where is the NCT07752784 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07752784 clinical trial?
NCT07752784 is sponsored by JYAMS PET Research & Development Limited. The trial plans to enroll 12 participants.
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