Cervical lymphatic-to-vein bypass surgery to help clear brain waste in people with Alzheimer's and intracranial lymphatic circulation disorder

Effect of Cervical Lymphaticovenous Anastomosis and Cervical Lymph Node to Vein Anastomosis for the Patient With Intracranial Lymphatic Circulation Disorder

This procedure will try connecting neck lymphatic vessels or lymph nodes to veins to see if it helps clear amyloid and improve thinking in people with Alzheimer's disease who have intracranial lymphatic circulation disorder.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 19 Years to 100 Years
• Sex: All
• Sponsor: Asan Medical Center (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT07328386 on ClinicalTrials.gov

What this trial studies

This single-center, prospective interventional trial will enroll adults with Alzheimer's disease and intracranial lymphatic circulation disorder confirmed by amyloid PET-CT or CSF testing and a Global Deterioration Scale score of 3–5. Enrolled participants will undergo cervical lymphaticovenous anastomosis (LVA) or lymph node-to-vein anastomosis (LNVA) performed with supermicrosurgical techniques. Cognitive function will be measured at baseline and at 1, 3, 6, 9, 12, 18, and 24 months postoperatively following standard clinical care schedules. The trial aims to determine whether creating bypass routes for lymphatic drainage improves amyloid clearance and cognitive trajectories.

Who should consider this trial

Good fit: Ideal candidates are adults (≥19 years) with Alzheimer's disease confirmed by amyloid PET-CT or CSF testing, a GDS score of 3–5, diagnosed intracranial lymphatic circulation disorder, able to give informed consent, and willing to attend postoperative follow-up visits.

Not a fit: Patients with vascular dementia, other structural brain disease, uncontrolled severe systemic illness, prior neck surgery, or known hypersensitivity to indocyanine green are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If successful, these microsurgical bypasses could improve clearance of brain waste such as amyloid and slow or partially reverse cognitive decline in affected patients.

How similar studies have performed: Supermicrosurgical LVA and LNVA have shown clinical benefit for peripheral lymphedema, but applying these techniques to intracranial lymphatic dysfunction and cognition is a novel approach with limited human data.

Eligibility criteria

Inclusion Criteria:

* Patients aged 19 years or older who are diagnosed with intracranial lymphatic circulation disorder based on neurological evaluation.
* Global Deterioration Scale (GDS) score between 3 and 5 at screening.
* Diagnosis of Alzheimer's disease confirmed by amyloid PET-CT or CSF amyloid testing, showing amyloid accumulation associated with lymphatic circulation disorder.
* Able to provide written informed consent to participate in the study voluntarily.

Exclusion Criteria:

* Unable to undergo follow-up evaluation for at least 12 months after surgery.
* Diagnosed with vascular dementia.
* Presence of structural brain disease other than intracranial lymphatic circulation disorder.
* Known hypersensitivity to indocyanine green (ICG).
* Uncontrolled systemic medical conditions such as severe cardiopulmonary, renal, hepatic, or endocrine disorders.
* History of previous neck surgery.
* Refusal to participate or failure to provide informed consent.
* Determined by the principal investigator to be unsuitable for participation due to any other clinical reason.

Where this trial is running

Seoul

• Asan Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Jin geon Guen, MD, PhD

Conditions: Intracranial Lymphatic Circulation Disorder, Alzheimer's Disease, Lymphaticovenous Anastomosis, Lymph Node-to-Vein Anastomosis, Amyloid Clearance, Cognitive Function, Dementia