Clinical trial NCT06918145: Clinical Study on Lymphaticovenous Anastomosis（LVA） for the Treatment of Alzheimer's Disease（AD）
Official title: Clinical Study on the Safety, Efficacy, and Mechanisms of Lymphaticovenous Anastomosis (LVA) for the Treatment of Alzheimer's Disease (AD)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alzheimer&Amp;#39;s Disease (AD)
Keywords: Alzheimer&#39;s Disease（AD）
Lymphaticovenous Anastomosis（LVA）
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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?


Eligibility criteria: 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.

Primary outcomes:
measure: The assessment of score changes after Lymphaticovenous Anastomosis(LVA) for the treatment of Alzheimer's Disease(AD) using Mini-Mental State Examination(MMSE).
timeFrame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months, 6 months,1 year, 3 years, 5 years.
Secondary outcomes:
measure: The safety of Lymphaticovenous Anastomosis(LVA) for the Treatment of Alzheimer's Disease(AD)
timeFrame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months, 6 months, 1 year, 3 years, 5 years.
Other outcomes:
measure: The mechanism of LVA treatment for AD patients
timeFrame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months, 6 months, 1 year, 3 years, 5 years.
Locations:
city: Beijing
country: China
facility: Peking university third hospital
state: Beijing
Study officials:
References:
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