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.

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location contact

Yue Ph.D

CONTACT

[email protected]

010-5997-5698

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.
Suspected hepatic encephalopathy.
Allergy to the investigational drug or any of its components.
Currently pregnant or breastfeeding.
Currently having a disease or condition that prolongs the QT interval.

Treatment and study plan

[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

Primary outcomes

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.

Secondary outcomes

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
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

Sponsors and collaborators

Lead sponsor

JYAMS PET Research & Development Limited

Industry

Registry information

Official study title

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.

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Aug 7, 2026
Registry last updated: Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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