Surgical technique to improve lymphatic drainage in Alzheimer's and Parkinson's diseases

A Prospective, Single-center, Single-arm, Exploratory, 24-Month Study to Confirm Efficacy of Modified Deep Cervical Lymphovenous Anastomosis (LVA) in Subjects With Alzheimer's Disease/ Parkinson's Disease

This study is testing a new surgery to see if it can help improve lymphatic drainage in people with Alzheimer's and Parkinson's diseases to potentially slow down their symptoms and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Zhejiang Provincial People's Hospital (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06852352 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy of modified deep cervical lymphovenous anastomosis (LVA) in patients with Alzheimer's disease (AD) and Parkinson's disease (PD). The approach aims to enhance the clearance of neurotoxic proteins by restoring lymphatic drainage, which may be compromised due to age-related lymphatic vessel atrophy. Participants will undergo the surgical procedure, followed by longitudinal assessments of cerebrospinal fluid and plasma biomarkers, neuroimaging, and clinical evaluations to determine the impact on disease progression and quality of life. The study seeks to establish a novel therapeutic strategy for these neurodegenerative disorders.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 50 to 80 diagnosed with mild cognitive impairment or dementia due to Alzheimer's disease, or with Parkinson's disease at various stages.

Not a fit: Patients with early-stage Alzheimer's or Parkinson's disease, or those with severe comorbidities that may complicate surgery, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly slow disease progression and improve the quality of life for patients with Alzheimer's and Parkinson's diseases.

How similar studies have performed: While the approach of using LVA for neurodegenerative diseases is novel, similar techniques have shown promise in other conditions related to lymphatic drainage.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Youmao Zheng

Conditions Alzheimer Disease; Parkinson Disease; LVA