[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606642":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":28,"responsibleParty":67,"collaborators":20,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":20,"enrollmentInfo":79,"targetDuration":20,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":20,"overallStatus":31,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"MMI (Medical Microinstruments, Inc.)","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Alzheimer's Disease","EXPERIMENTAL","Patient with confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria",[13],"Device: Symani Surgical System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Symani Surgical System","Use of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Clinical Operations","CONTACT","8336646276","5","clinical.ops@mmimicro.com",[29,50],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Stanford Medical Center","RECRUITING","Palo Alto","California","94305","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-122.14302,37.44188,{"lat":41,"lon":40},[44,47],{"name":45,"role":24,"phone":20,"phoneExt":20,"email":46},"Elizabeth Tadevosyan","etadyan@stanford.edu",{"name":48,"role":49,"phone":20,"phoneExt":20,"email":20},"Dung Nguyen, MD","PRINCIPAL_INVESTIGATOR",{"facility":51,"status":31,"city":52,"state":53,"zip":54,"country":35,"countryCode":36,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Baptist Health Research Institute","Jacksonville","Florida","32207",{"type":38,"coordinates":56},[57,58],-81.65565,30.33218,{"lat":58,"lon":57},[61,65],{"name":62,"role":24,"phone":63,"phoneExt":20,"email":64},"Karen Yesensky","904-202-7091","Karen.Yesensky@bmcjax.com",{"name":66,"role":49,"phone":20,"phoneExt":20,"email":20},"Ricardo Hanel, MD, PhD",{"type":68,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100606642","robotic-enabled-microsurgical-intervention-for-neurodegenerative-disease-100606642",false,"NCT07178210","Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease","Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A Global, Prospective, Early Feasibility Study in Alzheimer's Patients","REMIND","Inclusion Criteria:\n\n1. Patient aged 50 or older\n2. Patient has confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria\n3. Patient has a positive amyloid PET test and\u002For a positive CSF t-tau\u002Famyloid-beta-42 test\n4. Patient has an MMSE score within the mild to moderate range (21-26 and 10-20)\n5. Patient has CDR-SB score within the mild to moderate range; mild is 4.5to 9.0 and moderate is 9.5 to 15.5\n6. Patient has confirmed extracranial lymphatic abnormalities in the head and neck region as identified by preoperative imaging\n7. Investigator deems the candidate acceptable for lymphatic surgery with a robotic-assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)\n8. Patient or their legally authorized representative agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure\n\nExclusion Criteria:\n\n1. Patient (or their legally authorized representative) is unwilling to provide informed consent\n2. Patient has suspected dementia of other type, e.g., Lewy body, frontotemporal disorder, vascular, etc.\n3. Patient has documented or suspected neurological or intracranial conditions such as cerebrovascular accident, tumors, intracranial space occupying lesions, seizures or other intracranial\u002Fneurological conditions that may affect their safety in the study.\n4. History of head and neck radiation exposure\n5. Patient with severe kidney disease (GFR \\\u003C30 mL\u002Fmin\u002F1.73m2)\n6. Patient with acute kidney injury\n7. Active systemic infection under treatment with intravenous antibiotics\n8. Patient has a modified Rankin Score (mRS) of \\>4\n9. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigator's discretion\n10. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease\n11. Patient with an active cancer diagnosis and\u002For currently receiving treatment for cancer or has received treatment within the past 6 months\n12. Patient is currently receiving treatment or has been treated with anti-amyloid-beta monoclonal antibody therapy within the past 3 months\n13. Patient has contraindication for MRI or intrathecal administration of gadobutrol\n14. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or study outcomes\n15. Patient is ineligible to participate for other reasons in the judgment of the investigator","ALL","50 Years",{"count":80,"type":81},15,"ESTIMATED","INTERVENTIONAL",[84],"NA","The objective of this investigational device exemption (IDE) study is to evaluate the safety and feasibility of using the Symani System and microsurgical techniques in the deep cervical lymph node (dCLN) region in the setting of mild to moderate Alzheimer's disease and lymphatic abnormalities.",[87,88],"Alzheimer Disease","Lymphatic Obstruction","2026-06-01",{"date":91,"type":92},"2026-06-02","ACTUAL",{"date":94,"type":92},"2026-04-30",{"date":96,"type":81},"2027-10-30",{"name":5,"class":6},2]