NCT06852352Recruiting
An Exploratory Study to Confirm Efficacy of Modified Deep Cervical Lymphovenous Anastomosis (LVA) in Alzheimer's Disease/ Parkinson's Disease
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
Source: ClinicalTrials.gov · Last updated 11 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 18 Feb 2025
- Start date
- 28 Feb 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Diseases
- Alzheimer disease, Parkinson disease
- NCT number
- NCT06852352
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 28 Feb 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- MRI results suggesting intracranial active/acute pathologies, including infections, space-occupying lesions, major hemorrhages, or ≥4 lobar microhemorrhages;
- Conditions predisposing to increased intracranial hemorrhage risk, such as hematological disorders, hemorrhagic/coagulation disorders;
- Severe cardiac disease or hemodynamic instability;
- Uncontrolled severe hypertension;
- Substance use disorders (including illicit drugs, anesthetics, and alcohol dependence);
- Active severe infections, including HIV positivity and acute critical infections;
- Severe psychiatric disorders or significant suicide risk;
- History of untreated/uncured malignancies;
Lab values
- 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
Other
- Contraindications for MRI, ICG angiography, or PET scanning
- Contraindications for lumbar puncture
- Poorly controlled thyroid dysfunction;
- Cerebrovascular or systemic vasculopathy;
- Chronic hypnotic use (more than twice weekly for over one month);
- Participation in other interventional clinical trials within preceding 3 months;
- Poor compliance with inability/unwillingness to complete scheduled postoperative follow-ups;
- Other investigator-determined contraindications for trial participation.
Who the study is looking for
- Alzheimer's disease:
- Male or female, the age ranged from 50 to 75 years old
- Informed consent signed and dated by patient or legal representative
- Patients diagnosed principally with mild cognitive impairment or dementia caused by Alzheimer's disease
- Positive result of Amyloid PET imaging (Centiloids ≥37)
- HAMD score ≤17
- Hachinski score ≤4 Patients who meet ASA (American Society of Anesthesiologists) grade I-III criteria
- Parkinson's disease:
- Male or female, the age ranged from 50 to 80 years old
- Informed consent signed and dated by patient or legal representative
- 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
- Stage I-IV patients according to Hoehn and Yahr Scale
- 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
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.