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Cervical Lymphatic Microsurgery in Alzheimer's Disease

Sponsor: Daniel Maliszewski • ClinicalTrials.gov ID: NCT07857759

Registry updated: 2026-10-08

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Description

This pilot study will evaluate whether microsurgical modification of cervical lymphatic drainage may influence blood biomarkers and clinical outcomes in people with mild Alzheimer's disease. Thirty participants will be randomly assigned in a 1:1 ratio to either a surgical intervention group or a control group. Participants in the intervention group will undergo supermicrosurgical lymphaticovenous anastomosis (LVA) and/or lymph node-to-vein anastomosis (LNVA) in the neck to create an alternative pathway for lymphatic drainage. The procedure may be performed manually or with robotic microsurgical assistance. Participants in the control group will receive clinical observation without surgery during the first 12 months. The primary objective is to assess the change in plasma phosphorylated tau 217 (p-tau217) from baseline to 12 months. The study will also assess changes in cognitive and functional measures, including the Clinical Dementia Rating Sum of Boxes (CDR-SB), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Montreal Cognitive Assessment (MoCA), and Mini-Mental State Examination (MMSE), as well as the feasibility and safety of the surgical procedure. Participants will be assessed at baseline and at 3, 6, and 12 months. After completion of the 12-month observation period, participants in the control group may be offered the surgical procedure if they wish to undergo it.

Interventions

Cervical Lymphatic Microsurgery (Procedure)
Supermicrosurgical modification of cervical lymphatic drainage by creation of lymphaticovenous anastomosis (LVA) and/or lymph node-to-vein anastomosis (LNVA). Preoperative lymphatic and venous mapping is performed using ultra-high-frequency ultrasound and indocyanine green fluorescence imaging. The procedure is performed under general anesthesia and may be carried out manually or with robotic supermicrosurgical assistance. The specific anastomotic technique and configuration are selected according to the identified lymphatic and venous anatomy.

Eligibility criteria

Inclusion Criteria: * Age 18 years or older * Clinical diagnosis of mild Alzheimer's disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. * Clinical Dementia Rating (CDR) score of 0.5 to 1.0. * Mini-Mental State Examination (MMSE) score of 20 to 26. * Confirmation of Alzheimer's disease pathology using plasma biomarkers, with elevated phosphorylated tau 217 (p-tau217). * Stable pharmacological treatment for Alzheimer's disease for at least 3 months before enrollment. * Ability to provide informed consent or consent provided by a legally authorized representative. Exclusion Criteria: * Moderate or severe Alzheimer's disease. * Other neurodegenerative disorders or significant psychiatric disorders. * Previous major neck surgery or radiotherapy to the neck that may affect lymphatic drainage. * Contraindications to general anesthesia. * Active infection or coagulation disorders.

Conditions

Alzheimer Disease

Locations

Uniwersyteckie Centrum Kliniczne w Gdańsku — Gdansk, Poland
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o. — Słupsk, Poland

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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