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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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Qian Tang
tangqian@pet-tracer.com.cn
025-86166196
Backup
Heng He
heheng@pet-tracer.com.cn
025-86166196
Time Frame
Start Date: 2026-08-15
Estimated Completion Date: 2027-08-15
Participants
Target number of participants: 12
Treatments
Experimental: Cognitively Normal (HV)
Cognitively Normal will undergo PET imaging using \[18F\]-APN-1607
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
Related Therapeutic Areas
Sponsors
Leads: JYAMS PET Research & Development Limited

This content was sourced from clinicaltrials.gov

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