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Cervical Lymphatic Microsurgery in Alzheimer's Disease

RecruitingNAAges 18 Years - anyAllDaniel Maliszewski
NCT07857759 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 fu

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📋 Eligibility rules (as published)
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.
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What it tests

  • Cervical Lymphatic Microsurgery
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Where

2 sites
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Poland
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
Słupsk, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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