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Microsurgical Modification of Cervical Lymphatic Pathways in Alzheimer's Disease: A Pilot Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Poland
Uniwersyteckie Centrum Kliniczne w Gdańsku
RECRUITING
Gdansk
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
RECRUITING
Słupsk
Contact Information
Primary
Daniel Maliszewski, MD, PhD
danielmal2@gmail.com
+48 501784896
Backup
Kamil Chwojnicki, MD, PhD
kchwoj@gumed.edu.pl
+48 506135515
Time Frame
Start Date: 2026-09
Estimated Completion Date: 2029-05
Participants
Target number of participants: 30
Treatments
Experimental: Surgical Intervention
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.
No_intervention: Control
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.
Related Therapeutic Areas
Sponsors
Collaborators: University Clinical Centre, Gdansk, Janusz Korczak Provincial Specialist Hospital in Słupsk
Leads: Daniel Maliszewski

This content was sourced from clinicaltrials.gov