Modified deep cervical Lymphatic-Venous Anastomosis
Modified deep cervical Lymphatic-Venous Anastomosis: Deep cervical lymph-vein anastomosis surgery, connecting deep cervical lymph input vein vessels to enhance glymphatic-mediated protein clearance
Study summary
Alzheimer's disease (AD) and Parkinson's disease (PD) are characterized by pathological protein accumulation in the brain-Aβ/tau in AD and α-synuclein in PD. Recent studies have indicated that age-related lymphatic vessel atrophy compromises the metabolic clearance capacity of meningeal lymphatic vessels, potentially disrupting the equilibrium between production and clearance of Aβ/α-synuclein, ultimately leading to pathological accumulation of these proteins within the brain. Deep cervical lymphovenous anastomosis (LVA), a surgical technique proven effective in restoring lymphatic drainage in lymphedema, may enhance clearance of neurotoxic proteins by improving cervical lymphatic outflow. This project aims to evaluate the efficacy of modified deep cervical LVA in treating AD and PD, establishing a novel therapeutic strategy to modify disease progression and improve quality of life in neurodegenerative disorders, additionally offering the pathogenic mechanisms underlying neurodegenerative disorders.
Eligibility
Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
Alzheimer's disease:
1. Male or female, the age ranged from 50 to 75 years old
2. Informed consent signed and dated by patient or legal representative
3. Patients diagnosed principally with mild cognitive impairment or dementia caused by Alzheimer's disease
4. Positive result of Amyloid PET imaging (Centiloids ≥37)
5. HAMD score ≤17
6. Hachinski score ≤4 Patients who meet ASA (American Society of Anesthesiologists) grade I-III criteria
Parkinson's disease:
1. Male or female, the age ranged from 50 to 80 years old
2. Informed consent signed and dated by patient or legal representative
3. Patients diagnosed with Parkinson's disease or probable Parkinson's disease according to the Clinical Diagnostic Criteria for Parkinson's Disease in China (2016) or MDS
4. Stage I-IV patients according to Hoehn and Yahr Scale
5. Patients documented history of Parkinson's disease for more than 2-5 years to ensure clinical stability of symptoms and exclude the possibility of early misdiagnosis of other conditions
Exclusion Criteria:
1. Contraindications for MRI, ICG angiography, or PET scanning
2. Contraindications for lumbar puncture
3. Functional impairment of vital organs (cardiac, pulmonary, renal, hepatic), including reduced left ventricular ejection fraction, prolonged QT interval, severe pulmonary diseases, and severe hepatic/renal insufficiency
4. MRI results suggesting intracranial active/acute pathologies, including infections, space-occupying lesions, major hemorrhages, or ≥4 lobar microhemorrhages;
5. Conditions predisposing to increased intracranial hemorrhage risk, such as hematological disorders, hemorrhagic/coagulation disorders;
6. Poorly controlled thyroid dysfunction;
7. Cerebrovascular or systemic vasculopathy;
8. Severe cardiac disease or hemodynamic instability;
9. Uncontrolled severe hypertension;
10. Substance use disorders (including illicit drugs, anesthetics, and alcohol dependence);
11. Active severe infections, including HIV positivity and acute critical infections;
12. Severe psychiatric disorders or significant suicide risk;
13. Chronic hypnotic use (more than twice weekly for over one month);
14. History of untreated/uncured malignancies;
15. Participation in other interventional clinical trials within preceding 3 months;
16. Poor compliance with inability/unwillingness to complete scheduled postoperative follow-ups;
17. Other investigator-determined contraindications for trial participation.
Primary outcome measure(s)
Alzheimer's disease: Change in Clinical Dementia Rating Scale sum of the boxes (CDR-SB) — up to 2 years The Clinical Dementia Rating Scale sum of the boxes (CDR-SB) will be used to evaluate the general cognitive function. CDR-SB ranges from 0 to 18, and higher value represents a worse outcome.
Alzheimer's disease: Change in Mini-mental State Examination (MMSE) — up to 2 years The Mini-mental State Examination (MMSE) will be used to evaluate the general cognitive function. MMSE ranges from 0 to 30, and higher value represents a better outcome.
Alzheimer's disease: Change in Montreal Cognitive Assessment (MoCA) — up to 2 years The Montreal Cognitive Assessment (MoCA) will be used to evaluate the general cognitive function. MoCA ranges from 0 to 30, and higher value represents a better outcome.
Alzheimer's disease: Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Severe Version) (ADCS-ADL-SEV) — up to 2 years The ADCS-ADL-SEV consists of 19 items. Ratings reflect caregiver observations about the patient's actual functioning over the previous month and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 54, with lower values over time reflecting functional deterioration.
Parkinson's disease：Change in Unified Parkinson's Disease Rating Scale (UPDRS) — up to 2 years The scale assesses the functional status of patients with parksinon´s disease, including the independency of daily activities, mood, secondary effects of medications and motor complications. The total UPDRS score ranges from 0 to 199 points, with higher scores indicating more severe symptoms.
Parkinson's disease：Change in The Hoehn and Yahr Scale — up to 2 years The Hoehn and Yahr (H\&Y) scale is the most widely used and universally accepted staging system for overall functional disability in Parkinson's disease. The H\&Y Scale categorizes Parkinson's disease progression into 7 stages. Each stage reflects worsening motor function and loss of independence.
Parkinson's disease：Change in Parkinson's Disease Questionnaire-39 (PDQ-39) — up to 2 years The Parkinson's Disease Questionnaire-39 (PDQ-39) is a vital tool for assessing the quality of life in Parkinson's disease patients. The total score ranges from 0 to 100 points, with higher scores indicating worse quality of life.
Trial sites (1)
Facility
City
Region
Status
Zhejiang Provincial People's Hospital
Hangzhou
Zhejiang
Recruiting
More Zhejiang Provincial People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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