RecruitingPhase 3NCT07422857

Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function

Phase III Multicenter Clinical Trial Evaluating the Use of [18F]-APN-1607 Injection in Positron Emission Tomography in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function


Sponsor

JYAMS PET Research & Development Limited

Enrollment

316 participants

Start Date

Jan 22, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is to evaluate the efficacy and safety of \[18F\]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special brain imaging scan called a PET scan that uses a radioactive tracer called [18F]-APN-1607, which attaches to abnormal protein build-ups in the brain linked to Alzheimer's disease. Researchers want to see how well this scan can detect these changes in people with memory problems and people without. **You may be eligible if...** - You are 50 years old or older - You have been diagnosed with normal cognition, mild memory impairment, or Alzheimer's disease - You are able to undergo both brain MRI and PET scans - You are able to understand and sign a consent form - If you are a woman who could become pregnant, you are willing to use reliable contraception during and for 3 months after the study **You may NOT be eligible if...** - You have an atypical form of Alzheimer's disease - You are unable to tolerate MRI or PET scanning - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.


Locations(2)

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Huashan Hospital of Fudan University

Shanghai, Province, China

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NCT07422857