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
This study is to evaluate the efficacy and safety of \[18F\]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.
• Subjects must be able to understand and voluntarily sign a written informed consent form (ICF);
• Age ≥ 50 years, regardless of gender;
• Subjects with HV, MCI, and AD should meet the clinical diagnostic criteria
• Can tolerate brain MRI and PET imaging examinations;
• For women of potential fertility (not yet menopausal or within 2 years of menopause), effective contraception must be used during the study and for 3 months after the study (effective contraception refers to sterilization, intrauterine hormonal devices, condoms, birth control pills, abstinence, or partner vasectomy, etc.); male participants should agree to use contraception during the study and for 3 months after the study.