[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650796":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":34,"responsibleParty":57,"collaborators":24,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":24,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":24,"enrollmentInfo":69,"targetDuration":24,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":24,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"JYAMS PET Research & Development Limited","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitively Normal (HV)","EXPERIMENTAL","Cognitively Normal will undergo PET imaging using \\[18F\\]-APN-1607",[13],"Drug: [18F]-APN-1607",{"label":15,"type":10,"description":16,"interventionNames":17},"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",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","[18F]-APN-1607","Participants will receive a single intravenous injection of 5-7 mCi of \\[18F\\]-APN-1607, and a whole-body PET\u002FCT scan will begin immediately after administration",[15,9],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Qian Tang","CONTACT","025-86166196","tangqian@pet-tracer.com.cn",{"name":32,"role":28,"phone":29,"phoneExt":24,"email":33},"Heng He","heheng@pet-tracer.com.cn",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Beijing Tiantan Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100070","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50,54],{"name":51,"role":28,"phone":52,"phoneExt":24,"email":53},"Yan li Zhang","010-5997-5698","centralbrainbank@ncrcnd.org.cn",{"name":55,"role":56,"phone":24,"phoneExt":24,"email":24},"Yue Huang, Ph.D","PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100650796","phase-3-evaluate-the-concordance-between-pet-imaging-of-18f-apn-1607-injection-and-postmortem-brain-tissue-tau-pathology-in-individuals-with-hv-and-mci-or-ad-100650796",false,"NCT07752784","Evaluate the Concordance Between PET Imaging of [18F]-APN-1607 Injection and Postmortem Brain Tissue Tau Pathology in Individuals With HV and MCI or AD.","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.","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign a written informed consent form (ICF).\n2. Age≥50 years, male or female.\n3. Charlson Comorbidity Index (CCI)≥5.\n4. Able to tolerate imaging procedures.\n5. For MCI or AD subjects: clinically diagnosed as AD-derived cognitive impairment or Alzheimer's dementia.\n6. For HV subjects: no known personal or family history of AD-derived dementia.\n\nExclusion Criteria:\n\n1. Confirmed brain structural abnormalities that may affect PET reading, e.g., large stroke (infarct area\\>4 cm) or intracranial space-occupying lesion.\n2. Currently having clinically significant infectious diseases: HIV, hepatitis, etc.\n3. Currently participating in any investigational clinical trial.\n4. Previous participation in clinical studies of amyloid or tau-targeting agents.\n5. Suspected hepatic encephalopathy.\n6. Allergy to the investigational drug or any of its components.\n7. Currently pregnant or breastfeeding.\n8. Currently having a disease or condition that prolongs the QT interval.",true,"ALL","50 Years",{"count":70,"type":71},12,"ESTIMATED","INTERVENTIONAL",[74],"PHASE3","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.\n2. 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.\n3. To evaluate the safety of \\[18F\\]-APN-1607 injection.",[77],"Alzheimer's Disease","2026-08-14",{"date":80,"type":81},"2026-08-17","ACTUAL",{"date":83,"type":71},"2026-08-15",{"date":85,"type":71},"2027-08-15",{"name":5,"class":6},1]