An interventional study of Cervical Lymphatic Microsurgery in Alzheimer Disease, sponsored by Daniel Maliszewski. Recruiting at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Daniel Maliszewski · Not applicable, Interventional, and Basic science
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →This is the only study on the registry with Daniel Maliszewski as lead sponsor.
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Exclusion Criteria:
Participants assigned to this arm will undergo supermicrosurgical modification of cervical lymphatic drainage using lymphaticovenous anastomosis (LVA) and/or lymph node-to-vein anastomosis (LNVA). The procedure may be performed manually or with robotic microsurgical assistance.
Procedure: Cervical Lymphatic Microsurgery
Participants assigned to this arm will undergo clinical observation without surgical intervention during the first 12 months. After completion of the 12-month observation period, participants may elect to undergo the surgical 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.
Also known as: Lymph Node-to-Vein Anastomosis (LNVA), Lymphaticovenous Anastomosis (LVA)
Change in Plasma Phosphorylated Tau 217 (p-tau217) Concentration From Baseline to Month 12
Change in plasma phosphorylated tau 217 (p-tau217) concentration from baseline to the 12-month follow-up. The change over time will be compared between the surgical intervention and control groups.
Time frame: Baseline to Month 12
Change in CDR-Sum Score From Baseline to Month 12
Change in CDR-Sum score from baseline to the 12-month follow-up, compared between the surgical intervention and control groups.
Time frame: Baseline to Month 12
Change in ADCS-ADL Score From Baseline to Month 12
Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score from baseline to the 12-month follow-up, compared between the surgical intervention and control groups.
Time frame: Baseline to Month 12
Change in MoCA Score From Baseline to Month 12
Change in Montreal Cognitive Assessment (MoCA) score from baseline to the 12-month follow-up, compared between the surgical intervention and control groups.
Time frame: Baseline to Month 12
Change in MMSE Score From Baseline to Month 12
Change in Mini-Mental State Examination (MMSE) score from baseline to the 12-month follow-up, compared between the surgical intervention and control groups.
Time frame: Baseline to Month 12
Procedure-Related Adverse Events and Serious Adverse Events
Occurrence of adverse events and serious adverse events related to the surgical procedure during the study follow-up period.
Time frame: From surgery through Month 12
Postoperative Complications
Occurrence of postoperative complications following cervical lymphatic microsurgery, including local surgical complications assessed during follow-up.
Time frame: From surgery through Month 12
Rehospitalization
Occurrence of rehospitalization during the 12-month study follow-up period.
Time frame: Up to Month 12
All-Cause Mortality
Occurrence of death from any cause during the 12-month study follow-up period.
Time frame: Up to Month 12
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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