[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635606":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":30,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":30,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":88,"whyStopped":30,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Shanghai Mental Health Center","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-Frequency NSC-EVs","EXPERIMENTAL","Participants receive neural stem cell-derived exosomes by intranasal administration once every 3 days for 28 days. The single dose is 6 × 10\\^9 particles administered into both nostrils. In the low-frequency group, dosing is scheduled on Days 1, 4, 7, 10, 13, 16, 19, 22, 25, and 28, for a total of 10 doses.",[13],"Biological: Neural Stem Cell-Derived Exosomes",{"label":15,"type":10,"description":16,"interventionNames":17},"Medium-Frequency NSC-EVs","Participants receive neural stem cell-derived exosomes by intranasal administration every other day for 28 days. The single dose is 6 × 10\\^9 particles administered into both nostrils. In the medium-frequency group, dosing is scheduled on Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27, for a total of 14 doses.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"High-Frequency NSC-EVs","Participants receive neural stem cell-derived exosomes by intranasal administration once daily for 28 days. The single dose is 6 × 10\\^9 particles administered into both nostrils. In the high-frequency group, dosing is scheduled daily from Day 1 through Day 28, for a total of 28 doses.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","Neural Stem Cell-Derived Exosomes","The investigational product is a neural stem cell-derived exosome preparation administered intranasally. The product specification is 6 × 10\\^9 particles per 2 mL vial. The product is thawed to room temperature before administration and delivered into both nostrils. The same investigational product is used in all study groups; the groups differ only in dosing frequency.",[19,9,15],[29],"NSC-EVs",null,[32],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Yue Ling 岳玲, MD, PhD","CONTACT","18017311249","bellinthemoon@hotmail.com",[38],{"facility":5,"status":30,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Shanghai","Shanghai Municipality","200030","China","CN",{"type":45,"coordinates":46},"Point",[47,48],121.45806,31.22222,{"lat":48,"lon":47},[51],{"name":33,"role":34,"phone":52,"phoneExt":30,"email":36},"18964352661",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Ling YUE","Principal Investigator",[58],{"name":59,"class":60},"Shanghai Angecon Biotechnology Co., Ltd.","UNKNOWN","100635606","phase-1-study-of-neural-stem-cell-derived-exosomes-in-moderate-to-severe-early-onset-alzheimers-disease-100635606",false,"NCT07554872","Study of Neural Stem Cell-Derived Exosomes in Moderate-to-Severe Early-Onset Alzheimer's Disease","A Phase I, Open-Label, Single-Center, Frequency-Escalation Study of the Safety, Tolerability, and Preliminary Efficacy of Neural Stem Cell-Derived Exosomes in Patients With Moderate-to-Severe Early-Onset Alzheimer's Disease","* Inclusion Criteria:\n* Male or postmenopausal female, aged 50 to 75 years.\n* Meets the 2011 NIA-AA criteria for probable Alzheimer's disease dementia.\n* Age at onset ≤65 years.\n* CMMS score 5-20\n* Stable dose for at least 2 months before enrollment if receiving pro-cognitive or psychiatric medications.\n* Primary school education or above and able to complete study-required cognitive assessments.\n* Hachinski Ischemic Score ≤4.\n* GDS-30 total score ≤10.\n* Screening brain MRI+DWI+SWI meeting protocol-defined cerebrovascular exclusion thresholds and no major structural abnormalities inconsistent with Alzheimer's disease.\n* Positive amyloid pathology confirmed by Aβ-PET at screening or before enrollment.\n* Adequate vision and hearing to complete assessments.\n* Has a reliable caregiver able to accompany the participant to study visits and provide information for assessments.\n* Willing to participate and sign informed consent.\n\nExclusion Criteria:\n\n* Dementia due to causes other than Alzheimer's disease.\n* Brain MRI showing any of the following: Fazekas white matter hyperintensity score \\>2; more than 2 lacunar infarcts \\>1.5 cm; lacunar infarcts involving critical regions such as the thalamus, hippocampus, entorhinal cortex, or parahippocampal region; cerebral hemorrhage, subdural hematoma, aneurysm, arteriovenous malformation, intracranial mass lesion, or other clinically significant structural abnormalities.\n* Allergy to stem cell-derived exosomes or PET examination.\n* Severe psychiatric disorder or symptoms.\n* Significant active physical illness, including severe cardiac disease, severe systemic infection, or severe liver\u002Fkidney dysfunction.\n* Elevated tumor markers or tumor history.\n* Immune-related disease.\n* Significant nasal obstruction.\n* Serious suicide risk.\n* Participation in another clinical trial or stem cell therapy within the past 6 months.\n* Any other condition judged inappropriate by the investigator.\n* Contraindications to MRI or inability to complete MRI examinations, including non-MRI-compatible metallic implants, certain stents, plates, pacemakers, or severe claustrophobia.","ALL","50 Years","75 Years",{"count":72,"type":73},9,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","This is an open-label, single-center, phase I clinical study in patients with moderate-to-severe early-onset Alzheimer's disease. The study aims to evaluate the safety, tolerability, and preliminary efficacy of neural stem cell-derived exosomes (NSC-EVs) administered by the intranasal route. A total of 9 participants will be enrolled in 3 frequency-escalation groups: once every 3 days, once every other day, and once daily, each for 28 days. Participants will undergo screening and baseline assessment, a 28-day treatment period, and follow-up visits at 4, 8, and 24 weeks after the end of treatment.",[79],"Alzheimer Disease (AD)",[81,82,25,83,84,85,86,87],"Early-Onset Alzheimer's Disease","Moderate-to-Severe Alzheimer's Disease","Intranasal Administration","Phase I Clinical Study","Frequency Escalation","Safety","Tolerability","NOT_YET_RECRUITING","2026-05-13",{"date":91,"type":92},"2026-05-15","ACTUAL",{"date":94,"type":73},"2026-05",{"date":96,"type":73},"2027-12",{"name":5,"class":6},1]