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.

August 14, 2026 updated by: JYAMS PET Research & Development Limited

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.

  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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Yue Huang, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitively Normal (HV)
Cognitively Normal will undergo PET imaging using [18F]-APN-1607
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
Experimental: Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer's Disease or Mild Cognitive Impairment subjects will undergo PET imaging using [18F]-APN-1607
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the consistency between the visual interpretation results of [18F]-APN-1607 injection PET imaging and the authenticity standards.
Time Frame: 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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the results of semi-quantitative PET imaging analysis (SUVR) and brain tissue pathological NFT scores.
Time Frame: 8 months
Correlation analysis between categorized NFT scores and regional PET SUVRs
8 months
Evaluation of the safety of [18F]-APN-1607 injection.
Time Frame: 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
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JYAMS PET Research & Development Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

August 15, 2027

Study Registration Dates

First Submitted

July 29, 2026

First Submitted That Met QC Criteria

August 3, 2026

First Posted (Actual)

August 7, 2026

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCAMS-F10-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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