Alzheimer&Amp;#39;s Disease (AD)
Conditions
Keywords
Alzheimer's Disease（AD）, Lymphaticovenous Anastomosis（LVA）
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?
Interventions
PROCEDURELymphaticovenous Anastomosis
The basic principle of LVA surgery is to anastomose the deep cervical lymphatic vessels of the brain with adjacent small veins, effectively enabling the direct reflow of accumulated Aβ and tau proteins in the brain's lymphatic circulation into the venous system, thereby improving the symptoms of Alzheimer's Disease (AD).
Sponsors
Peking University Third Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The assessment of score changes after Lymphaticovenous Anastomosis(LVA) for the treatment of Alzheimer's Disease(AD) using Mini-Mental State Examination(MMSE). | From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months, 6 months,1 year, 3 years, 5 years. | The assessment of score changes by Mini-Mental State Examination(MMSE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The safety of Lymphaticovenous Anastomosis(LVA) for the Treatment of Alzheimer's Disease(AD) | From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months, 6 months, 1 year, 3 years, 5 years. | The complications associated with LVA treatment for AD, including perioperative complications and long-term complications. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The mechanism of LVA treatment for AD patients | From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months, 6 months, 1 year, 3 years, 5 years. | The changes occur in AD-related biomarkers（Aβ42、 Aβ40、Aβ42/40、pTau217、pTau181） before and after surgery. |
Countries
China
Outcome results
None listed