Alzheimer's Disease
Conditions
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.
Interventions
DRUG[18F]-APN-1607
Participants will receive a single intravenous injection of 5-7 mCi of \[18F\]-APN-1607, and a whole-body PET/CT scan will begin immediately after administration
Sponsors
JYAMS PET Research & Development Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the consistency between the visual interpretation results of [18F]-APN-1607 injection PET imaging and the authenticity standards. | 8 months | Summary of visual reads by 5 blinded readers and concordance analysis between NIA-AA postmortem neuropathology and \[18F\]-APN-1607 PET visual reads. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the results of semi-quantitative PET imaging analysis (SUVR) and brain tissue pathological NFT scores. | 8 months | Correlation analysis between categorized NFT scores and regional PET SUVRs |
| Evaluation of the safety of [18F]-APN-1607 injection. | 8 months | Safety for the administration of \[18F\]-APN-1607 and PET scanning is measured by number of participants with Adverse events / Serious adverse events |
Countries
China
Contacts
CONTACTQian Tang
CONTACTHeng He
Outcome results
None listed