[18F]-APN-1607
DrugParticipants 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.
NCT Number: NCT07422857
This study is to evaluate the efficacy and safety of [18F]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Phase 3
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 15 months
Sensitivity and specificity of PET imaging visual interpretation results of [ 18 F]-APN-1607 injection compared with true standards
Time frame: 15 months
Based on [18F]-APN-1607 PET, the sensitivity and specificity of area under the curve (AUC) with semi-quantitative analysis of standardized uptake values (SUVR) of brain regions of comprehensive interest (iROI) in the brain to distinguish HV subjects from AD-related cognitive impairment subjects (MCI+AD), as well as MCI subjects from AD subjects.
Time frame: 15 months
Safety for theadministration of [18F]APN-1607 and PET scanning is measured by number of participants with Adverse events / Serious adverse events
JYAMS PET Research & Development Limited
Industry
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
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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