Clinical Study on Lymphaticovenous Anastomosis（LVA） for the Treatment of Alzheimer's Disease（AD） (LVA; AD)

Peking University

Status: Invitation-only

Conditions: Alzheimer&Amp;#39;s Disease (AD)

Treatments: Procedure: Lymphaticovenous Anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT06918145

IRB00006761-M20250166

Details and patient eligibility

About

The goal of this clinical trial is to explore the safety and efficacy of Lymphaticovenous Anastomosis (LVA) for the Treatment of Alzheimer's Disease (AD). The main questions it aims to answer are:

1. After LVA surgery treatment, do patients with AD show improvement in dementia, cognitive impairment, neurobehavioral symptoms?
2. What are the complications associated with LVA treatment for AD, including perioperative complications and long-term complications?
3. What is the mechanism of LVA treatment for AD patients, and what changes occur in AD-related biomarkers (Aβ42、 Aβ40、Aβ42/40、pTau217、pTau181) before and after surgery?

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with Alzheimer's Disease based on biomarkers, imaging, and clinical symptoms;
2. Male or female aged 50-85 years (inclusive);
3. At least one caregiver who can live with the patient for an extended period;
4. No severe systemic diseases affecting the heart, liver, kidneys, etc.;
5. Patients who voluntarily participate in clinical recruitment, accept the LVA surgical treatment plan, and sign the informed consent form.

Exclusion criteria

1. Poor overall health, unable to tolerate surgery;
2. Preoperative anesthetic assessment indicates inability to tolerate general anesthesia;
3. Presence of other neurological or psychiatric disorders;
4. Severe bleeding tendency due to coagulopathy;
5. Inability to comply with treatment and follow-up;
6. Other conditions that preclude tolerance to surgery.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Lymphaticovenous Anastomosis(LVA) for the Treatment of Alzheimer's Disease(AD)

Experimental group

Treatment:

Procedure: Lymphaticovenous Anastomosis