Health Trials

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.

ConditionAlzheimer's Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorJYAMS PET Research & Development Limited

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • [18F]-APN-1607

    Drug

    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

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Cognitively Normal (HV)Experimental treatment 1 intervention
Group B: Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the consistency between the visual interpretation results of [18F]-APN-1607 injection PET imaging and the authenticity standards.

Summary of visual reads by 5 blinded readers and concordance analysis between NIA-AA postmortem neuropathology and \[18F\]-APN-1607 PET visual reads.

Time frame
8 months

Secondary outcomes

1

Correlation between the results of semi-quantitative PET imaging analysis (SUVR) and brain tissue pathological NFT scores.

Correlation analysis between categorized NFT scores and regional PET SUVRs

Time frame
8 months
2

Evaluation of the safety of [18F]-APN-1607 injection.

Safety for the administration of \[18F\]-APN-1607 and PET scanning is measured by number of participants with Adverse events / Serious adverse events

Time frame
8 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

JYAMS PET Research & Development Limited

Lead sponsor

Source ClinicalTrials.gov
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