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Life sciences · Interventional Study
ClinicalTrials.gov · October 5, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07857759). This is a study registration, not published results. Lead sponsor: Daniel Maliszewski. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Alzheimer Disease. Interventions: PROCEDURE: Cervical Lymphatic Microsurgery. Primary outcome measures: Change in Plasma Phosphorylated Tau 217 (p-tau217) Concentration From Baseline to Month 12 , Baseline to Month 12. Brief summary: 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 CDR-Sum, ADCS-ADL, MoCA, and 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.