Restoring Cervical Lymphatic Drainage in Alzheimer’s Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center pilot interventional study enrolling five participants with Alzheimer's disease. Each participant undergoes a cervical lymphovenous anastomosis (LVA) to enhance drainage through the deep cervical lymphatic system. The study will look for changes in biological markers, brain imaging findings, and clinical measures to see if restoring drainage might influence disease processes. Eligible participants are those diagnosed by modern criteria, not eligible for other disease-modifying therapies, and capable of providing informed consent. Exclusion criteria include coagulopathy, prior cervical surgery or radiotherapy, active infections, uncontrolled systemic disease, recent interventional trials, and contraindications to anesthesia or indocyanine green.

Why it matters

Who can join: the full rules

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.

Where it's running

• Azienda Ospedaliera Universitaria Le Scotte
  Siena, Tuscany, Italy Recruiting

Study contacts

• Principal investigator: Domenico Plantone, Professor — University of Siena, Department of Neurology
• Study coordinator: Andrea Frosolini, MD
• Email: andreafrosolini@gmail.com
• Phone: 3939447318

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.