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Restoring Cervical Lymphatic Drainage in Alzheimer's Disease

RecruitingNAAges any - anyAllUniversity of Siena
NCT07854327 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Alzheimer's disease (AD) is a progressive neurodegenerative disorder associated with the accumulation of abnormal proteins, including amyloid-beta and tau, in the brain. Recent evidence suggests that the glymphatic and meningeal lymphatic systems, which contribute to the removal of waste products from the brain, may play a role in AD. In particular, impaired drainage through the deep cervical lymphatic system may contribute to the accumulation of disease-related proteins. The LymphDAD study is a prospective, single-center pilot study designed to explore whether surgically improving cervical lymphatic drainage may be associated with changes in biological markers, brain imaging, and cognitive and clinical measures in selected patients with AD who are not eligible for currently available disease-modifying treatments. Five participants with AD will undergo a minimally invasive microsurgica

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of Alzheimer's disease according to NIA-AA 2024 criteria. * Not eligible for other disease-modifying therapies. * Ability to personally provide written informed consent after clinical evaluation -of decisional capacity. Exclusion Criteria: * Coagulopathy or active infection of the head and neck region. * Prior extensive cervical lymph node dissection or radiotherapy. * Uncontrolled systemic disease or contraindication to general anesthesia. * Participation in another interventional trial within the previous 3 months. * Known hypersensitivity or allergy to indocyanine green. * Evidence of alternative or concomitant causes of cognitive decline other than Alzheimer's disease, such as subdural hematoma, primary or metastatic brain malignancy, or normal-pressure hydrocephalus. * Current or recent treatment with immunosuppressive or immunomodulatory therapy within the previous 3 months. * Clinically significant infectious disease within the previous 6 months. * Severe psychiatric disorder that could interfere with cognitive assessment or study participation. * Pregnancy or breastfeeding. * End-stage malignant disease with an estimated life expectancy of less than 6 months. * History indicative of systemic autoimmune disease. * Inability to personally provide valid informed consent.
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What it tests

  • Cervical lymphovenous anastomosis (LVA)
  • Cervical lymphovenous anastomosis (LVA)
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Where

1 site
Azienda Ospedaliera Universitaria Le Scotte
Siena, Italy
🤝 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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