This study is to evaluate the efficacy and safety of \[18F\]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
316
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.
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGHuashan Hospital of Fudan University
Shanghai, Province, China
RECRUITINGEvaluate the effectiveness of visual reading results of [18 F]-APN-1607 injection PET imaging in detecting tau NFTs(Neurofibrillary Tangles)
Sensitivity and specificity of PET imaging visual interpretation results of \[ 18 F\]-APN-1607 injection compared with true standards
Time frame: 15 months
Assessment of [18 F]-APN-1607 Uptake Patterns by Regional SUVR Values and the capability in differentiating different groups
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 and Tolerability Profile Measured by Adverse Events (AEs)
Safety for theadministration of \[18F\]APN-1607 and PET scanning is measured by number of participants with Adverse events / Serious adverse events
Time frame: 15 months
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