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RECRUITING Not applicable ClinicalTrials.gov

Restoring Cervical Lymphatic Drainage in Alzheimer's Disease

Sponsor: University of Siena • ClinicalTrials.gov ID: NCT07854327

Registry updated: 2026-10-02
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Description

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 microsurgical procedure called lymphovenous anastomosis (LVA), in which small cervical lymphatic vessels are connected to nearby small veins to facilitate lymphatic drainage. During the procedure, a small sample of lymphatic fluid will also be collected for exploratory analysis of amyloid-beta and tau proteins. Participants will undergo clinical and neuropsychological assessments, blood sampling, magnetic resonance imaging (MRI), and amyloid positron emission tomography (PET) before the procedure and during follow-up. Follow-up assessments will be performed at 1, 3, 6, and 12 months after surgery. The study is exploratory and is not designed to demonstrate a definitive clinical benefit. Its primary purpose is to obtain preliminary information on the feasibility, safety, and possible biological and clinical effects of cervical LVA in AD, which may support the design of future controlled studies.

Interventions

  • Cervical lymphovenous anastomosis (LVA) (Procedure)
    Microsurgical restoration of cervical lymphatic drainage by connecting patent lymphatic channels to small-caliber cervical venous branches. The procedure is performed along the posterior edge of the sternocleidomastoid muscle using supermicrosurgical techniques. Indocyanine green (ICG) fluorescence lymphography is used to identify lymphatic vessels and assess anastomotic flow. A small sample of lymphatic fluid is collected intraoperatively from a lymphatic channel already exposed during the procedure for exploratory analysis of amyloid-beta and tau biomarkers.
  • Cervical lymphovenous anastomosis (LVA) (Procedure)
    Microsurgical restoration of cervical lymphatic drainage by connecting patent lymphatic channels to small-caliber cervical venous branches. In this study, lymphovenous anastomoses will be created along the posterior edge of the sternocleidomastoid muscle using supermicrosurgical techniques. Indocyanine green (ICG) fluorescence lymphography will guide lymphatic identification and assess anastomotic patency. A small sample of lymphatic fluid will also be collected intraoperatively from an exposed lymphatic channel for exploratory biomarker analysis.

Eligibility criteria

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.

Conditions

Alzheimer Alzheimer Dementia (AD)

Locations

  • Azienda Ospedaliera Universitaria Le Scotte — Siena, Tuscany, Italy
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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