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.

NCT07752784 | Not Yet Recruiting Phase 3

• 1 other identifier: DCAMS-F10-303
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.To evaluate the safety of \[18F\]-APN-1607 injection.

Conditions

Alzheimer's Disease

Outcome Measures

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.

  8 months

Secondary Outcomes (2)

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

  8 months

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

  8 months

Study Arms (2)

Cognitively Normal (HV)

EXPERIMENTAL

Cognitively Normal will undergo PET imaging using \[18F\]-APN-1607

Drug: [18F]-APN-1607

Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)

EXPERIMENTAL

Alzheimer's Disease or Mild Cognitive Impairment subjects will undergo PET imaging using \[18F\]-APN-1607

Drug: [18F]-APN-1607

Interventions

[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

Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI); Cognitively Normal (HV)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JYAMS PET Research & Development Limited: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 7, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)