Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:13 PM
Study NCT ID:
NCT07458620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Single-Arm Safety Study of Cervical LVA in AD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (Safety and Feasibility)', 'timeFrame': 'From the start of surgery up to 1 month post-operation.', 'description': 'Assessment of the safety and feasibility of bilateral cervical supermicrosurgical lymphaticovenular anastomosis (LVA). Safety is evaluated by the frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring from the start of the surgical procedure through the 1-month post-operative follow-up period. Events are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Mini-Mental State Examination (MMSE) Score', 'timeFrame': 'Baseline and 6 months post-operation', 'description': 'A 30-point questionnaire used to measure cognitive impairment. Lower scores indicate greater impairment.'}, {'measure': 'Change from Baseline in Clinical Dementia Rating (CDR)', 'timeFrame': 'Baseline and 6 months post-operation.', 'description': 'A scale used to characterize the level of cognitive and functional performance.'}, {'measure': 'Changes from Baseline in Cognitive Abilities Screening Instrument (CASI)', 'timeFrame': 'Baseline and 6 months post-operation.', 'description': 'The CASI is a comprehensive tool used to assess multiple cognitive domains, including attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, and abstraction. It provides a more detailed assessment than the MMSE, with a total score ranging from 0 to 100. Higher scores indicate better cognitive performance, while lower scores represent greater impairment.'}, {'measure': 'Change in Brain Amyloid-beta Deposition via PET Scan', 'timeFrame': 'Baseline and post-operation.', 'description': 'Assessment of the change in brain amyloid plaque density using \\[18F\\] Florbetapir (Amyloid-PET) imaging. This measures whether the surgical intervention has facilitated the clearance of pathological proteins.'}, {'measure': 'Change in Plasma Neurodegenerative Biomarker Levels', 'timeFrame': 'Baseline and post-operation.', 'description': 'Quantification of plasma levels for GFAP and NfL. These markers are used to track neuroaxonal damage and protein clearance efficiency.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Alzheimer's Disease (AD)", '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'], 'conditions': ["Alzheimer's Disease (AD)"]}, 'referencesModule': {'references': [{'pmid': '26030524', 'type': 'BACKGROUND', 'citation': 'Louveau A, Smirnov I, Keyes TJ, Eccles JD, Rouhani SJ, Peske JD, Derecki NC, Castle D, Mandell JW, Lee KS, Harris TH, Kipnis J. Structural and functional features of central nervous system lymphatic vessels. Nature. 2015 Jul 16;523(7560):337-41. doi: 10.1038/nature14432. Epub 2015 Jun 1.'}, {'pmid': '40083619', 'type': 'BACKGROUND', 'citation': "Hong JP, Chen WF, Nguyen DH, Xie Q. A Proposed Role for Lymphatic Supermicrosurgery in the Management of Alzheimer's Disease: A Primer for Reconstructive Microsurgeons. Arch Plast Surg. 2025 Jan 30;52(2):96-103. doi: 10.1055/a-2513-4313. eCollection 2025 Mar."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Official Title Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients with Alzheimer's Disease\n\nScientific Rationale Neurodegenerative diseases like Alzheimer's (AD) are characterized by the misfolding and accumulation of proteins such as Amyloid-beta and Tau. The glymphatic and meningeal lymphatic systems serve as the primary pathways for clearing these metabolic wastes from the central nervous system into the deep cervical lymph nodes. This study investigates whether enhancing this drainage via supermicrosurgical lymphaticovenular anastomosis (LVA) can reduce intracranial protein burden and systemic oxidative stress.\n\nStudy Design and Intervention This is a prospective, single-arm safety study. Participants undergo bilateral cervical LVA. Using Indocyanine Green (ICG) fluorescence lymphography for navigation, lymphatic vessels in the neck are identified and anastomosed to adjacent small veins to facilitate lymph drainage into the venous circulation.\n\nSafety Monitoring and Data Integrity Primary Safety Endpoint: The study defines safety as a Serious Adverse Event (SAE) rate of ≤10% within the first month post-operation. Events are graded using CTCAE v5.0.\n\nIndependent Oversight: To ensure objectivity, cognitive and behavioral assessments (including MMSE, CDR, and CASI) are conducted by clinical psychologists who are not members of the core research team.\n\nExternal Auditing: An independent Clinical Research Organization (CRO) has been contracted to perform four periodic audits to verify data accuracy and GCP compliance.\n\nExploratory Objectives\n\nThe study will track longitudinal changes in:\n\nFluid Biomarkers: Plasma levels of Amyloid-beta 40/42, p-Tau 217, GFAP, and Nf-L at baseline, 1, 6, and 12 months.\n\nNeuroimaging: Amyloid-PET and FDG-PET scans at baseline and 12 months to evaluate protein deposition and metabolic activity.\n\nClinical Outcomes: Changes in cognitive scores (CDR, MMSE, CASI, NPI) from baseline to 6 months post-surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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."}, 'identificationModule': {'nctId': 'NCT07458620', 'acronym': 'Neck LVA', 'briefTitle': 'Prospective Single-Arm Safety Study of Cervical LVA in AD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': "Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients With Alzheimer's Disease", 'orgStudyIdInfo': {'id': '202500102A0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-Arm Cervical LVA Intervention Supporting Context Arm Type', 'description': "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.", 'interventionNames': ['Procedure: Supermicrosurgical Lymphaticovenular Anastomosis (LVA)']}], 'interventions': [{'name': 'Supermicrosurgical Lymphaticovenular Anastomosis (LVA)', 'type': 'PROCEDURE', 'description': '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 \\<0.8mm) 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.', 'armGroupLabels': ['Single-Arm Cervical LVA Intervention Supporting Context Arm Type']}]}, 'contactsLocationsModule': {'locations': [{'zip': '833', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'contacts': [{'name': 'Johnson Chia-Shen Yang, MD, PhD', 'role': 'CONTACT', 'email': 'johnson.c.yang@gmail.com', 'phone': '+886-975056253'}], 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Johnson Chia-Shen Yang,, MD, PhD', 'role': 'CONTACT', 'email': 'johnson.c.yang@gmail.com', 'phone': '+886-975056253'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "1. Data Protection and Retention Limits: The protocol strictly mandates that all de-identified data and specimens will be destroyed five years after the formal conclusion of the trial.\n2. Privacy and Confidentiality: To protect the privacy of participants, data is stored under locked and encrypted conditions, with access restricted to the immediate research team members.\n3. Restricted Future Use: While participants can consent to have their data stored in the hospital's internal biobank, this authorization is limited specifically to future research within Kaohsiung Chang Gung Memorial Hospital and does not extend to public or external sharing.\n4. Legal Representative Consent: Because the study involves participants with cognitive impairments who may lack the capacity to exercise autonomy, data management is subject to strict ethical oversight that prioritizes the protection of the participants' rights over broad data dissemination."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}