[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628206":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":20,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":20,"enrollmentInfo":55,"targetDuration":20,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":78,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Chang Gung Memorial Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-Arm Cervical LVA Intervention Supporting Context Arm Type","EXPERIMENTAL","The single experimental arm involves bilateral cervical supermicrosurgical Lymphaticovenular Anastomosis (LVA). Participants undergo a surgical procedure where high-power microscopy is used to identify cervical lymphatic vessels. These vessels are then microsurgically connected (anastomosed) to adjacent small veins to create an extra-cranial bypass.\n\nThe intervention utilizes Indocyanine Green (ICG) fluorescence imaging to precisely map the lymphatic drainage pathways in the neck. The primary goal of this bypass is to enhance the clearance of metabolic waste-specifically Amyloid-beta and tau proteins-from the brain by facilitating their drainage from the glymphatic and meningeal lymphatic systems into the systemic venous circulation. This trial evaluates the safety and feasibility of this approach in mitigating the progression of Alzheimer's Disease.",[13],"Procedure: Supermicrosurgical Lymphaticovenular Anastomosis (LVA)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Supermicrosurgical Lymphaticovenular Anastomosis (LVA)","This intervention is uniquely distinguished by its use of supermicrosurgery to perform bilateral cervical Lymphaticovenular Anastomosis (LVA) as a direct physiological treatment for Alzheimer's Disease. Unlike traditional pharmacological trials that target protein production or aggregation, this surgical approach focuses on the mechanical clearance of metabolic waste.\n\nA key technical differentiator is the specific targeting of neck lymph nodes using Indocyanine Green (ICG) fluorescence to map the drainage pathway of cerebrospinal fluid. This allows for a precise, \"super-microsurgical\" bypass (connecting vessels often \\\u003C0.8mm) in the neck. This method aims to bypass potential blockages in the aging dCLNs (deep cervical lymph nodes), directly enhancing the outflow of Amyloid-beta and Taufrom the glymphatic and meningeal systems into the venous circulation.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Johnson Chia-Shen Yang,, MD, PhD","CONTACT","+886-975056253","johnson.c.yang@gmail.com",[28],{"facility":29,"status":20,"city":30,"state":20,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Kaohsiung Chang Gung Memorial Hospital","Kaohsiung City","833","Taiwan","TW",{"type":35,"coordinates":36},"Point",[37,38],120.31333,22.61626,{"lat":38,"lon":37},[41],{"name":42,"role":24,"phone":25,"phoneExt":20,"email":26},"Johnson Chia-Shen Yang, MD, PhD",{"type":44,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100628206","phase-1-prospective-single-arm-safety-study-of-cervical-lva-in-ad-patients-100628206",false,"NCT07458620","Prospective Single-Arm Safety Study of Cervical LVA in AD Patients","Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients With Alzheimer's Disease","Neck LVA","Inclusion Criteria:\n\n* Diagnosis of Alzheimer's Disease: Participants must have a confirmed diagnosis of Alzheimer's Disease as evaluated by a neurologist and a psychiatrist at the hospital.\n* Positive Amyloid-PET Scan: The result of a \\[18F\\] Florbetapir (Amyloid-PET) scan must be positive, indicating the presence of amyloid plaques in the brain.\n* Willingness to Consent: Participants or their legal representatives must be willing to sign a written informed consent form.\n* Participants must be adults aged 18 years or older\n\nExclusion Criteria:\n\n* Lack of Informed Consent: Potential participants are excluded if they are unable to exercise autonomy and informed consent cannot be obtained from a legal representative or authorized person.\n* Prior Surgical History: Individuals who have previously undergone neck lymphatic dissection, nasopharyngeal surgery, or intracranial surgery are excluded.\n* Concurrent Medical Conditions: The trial excludes persons with thyroid disease or chronic heart failure.\n* Specific Allergies: Candidates with a history of allergies to shellfish or iodine are excluded due to the use of Indocyanine Green (ICG) during the procedure.\n* Unresolved Concerns: Anyone who has doubts about the trial and cannot receive satisfactory answers is excluded.\n* Anesthesia Risks: Individuals deemed medically unfit for general anesthesia-for example, those with severe cardiopulmonary insufficiency or a history of specific anesthetic drug allergies-are ineligible.","ALL","18 Years",{"count":56,"type":57},35,"ESTIMATED","INTERVENTIONAL",[60],"PHASE1","Official Title Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients with Alzheimer's Disease\n\nPurpose of the Study Researchers are conducting this study to see if a minimally invasive microsurgery, called Cervical Lymphaticovenular Anastomosis (LVA), is safe for people with Alzheimer's Disease.\n\nHow the Surgery Works Alzheimer's Disease is linked to the buildup of metabolic waste products (certain proteins) in the brain. Recent medical discoveries show that these wastes normally drain through small channels in the neck into the blood system. In this study, surgeons will use high-powered microscopes to connect these drainage channels (lymphatic vessels) in the neck directly to small nearby veins. The goal is to create a \"detour\" that helps the brain clear out these harmful proteins more effectively.\n\nWhat to Expect Safety First: The main goal is to find out if the surgery is safe and well-tolerated by patients.\n\nThe Procedure: The surgery is performed under general anesthesia and typically takes 4 to 6 hours. It involves small (about 5 cm) incisions on both sides of the neck.\n\nFollow-up: Participants will be monitored for at least 12 months. Researchers will use memory tests, brain scans (MRI and PET), and blood tests to see if the surgery helps with daily activities or slows down memory loss.",[63],"Alzheimer's Disease (AD)",[63,65,66,67,68,69,70,71,72,73,74,75,76,77],"Neurodegenerative Diseases","Dementia","Lymphaticovenular Anastomosis (LVA)","Supermicrosurgery","Cervical Lymphatic Bypass","Glymphatic System Clearance","Meningeal Lymphatic System","Amyloid-beta (Aβ) Drainage","Tau Protein Clearance","CSF","Deep Cervical Lymph Nodes (dCLNs)","Amyloid-PET Imaging","Indocyanine Green (ICG) Lymphography","NOT_YET_RECRUITING","2026-03-04",{"date":81,"type":82},"2026-03-09","ACTUAL",{"date":84,"type":57},"2026-03",{"date":86,"type":57},"2028-09",{"name":5,"class":6},1]