An interventional study of Modified deep cervical Lymphatic-Venous Anastomosis in Alzheimer Disease and Parkinson Disease, sponsored by Zhejiang Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Zhejiang Provincial People's Hospital · Not applicable, Interventional, and Treatment
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.
Alzheimer's disease (AD) and Parkinson's disease (PD) are progressive neurodegenerative disorders characterized by pathological protein aggregation-Aβ plaques and tau tangles in AD, and α-synuclein Lewy bodies in PD. Emerging evidence implicates that the glymphatic-meningeal lymphatic system and deep cervical lymph nodes constitute the central pathway for metabolite clearance of cerebral macromolecules. Aging-associated lymphatic vessel atrophy disrupts the equilibrium between protein production and clearance, exacerbating neurotoxicity. Deep cervical lymphovenous anastomosis (LVA), a surgical technique validated in lymphedema management, aims to restore cervical lymphatic drainage and enhance glymphatic-mediated protein clearance. This study investigates the therapeutic potential of modified deep cervical LVA in AD and PD. A prospective cohort will undergo modified deep cervical LVA with longitudinal assessments, including cerebrospinal fluid (CSF) and plasma biomarkers (Aβ42, p-tau181, p-tau217, GFAP, NfL, α-synuclein), neuroimaging (MRI and PET-CT), and clinical endpoints (CDR, MMSE, MoCA, BADL and IADL for AD, UPDRS and PDQ-39 for PD). Mechanistically, we hypothesize that modified deep cervical LVA will reduce intracranial pressure gradients, augment meningeal lymph flow, and accelerate interstitial waste drainage, thereby mitigating neuroinflammation and neuronal damage. This trial aims to verify the efficacy of modified deep cervical LVA to modify disease progression in AD and PD, providing a surgically scalable approach to delay progression of neurodegenerative disorders and improve patient quality of life.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 160 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Zhejiang Provincial People's Hospital is the lead sponsor of 60 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Alzheimer's disease:
Parkinson's disease:
Exclusion Criteria:
Procedure: 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
Alzheimer's disease: Change in Clinical Dementia Rating Scale sum of the boxes (CDR-SB)
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.
Time frame: up to 2 years
Alzheimer's disease: Change in Mini-mental State Examination (MMSE)
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.
Time frame: up to 2 years
Alzheimer's disease: Change in Montreal Cognitive Assessment (MoCA)
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.
Time frame: up to 2 years
Alzheimer's disease: Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Severe Version) (ADCS-ADL-SEV)
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.
Time frame: up to 2 years
Parkinson's disease：Change in Unified Parkinson's Disease Rating Scale (UPDRS)
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.
Time frame: up to 2 years
Parkinson's disease：Change in The Hoehn and Yahr Scale
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.
Time frame: up to 2 years
Parkinson's disease：Change in Parkinson's Disease Questionnaire-39 (PDQ-39)
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.
Time frame: up to 2 years
Alzheimer's disease: Change in amyloid deposit in brain
Change from baseline as measured by amyloid positron emission tomography (PET) scan using centiloids. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline.
Time frame: baseline, 1year, 2 years
Alzheimer's disease: Change in brain Tau deposition in a subset of participants
Change from baseline as measured by Tau PET scan
Time frame: baseline, 1year, 2 years
Alzheimer's disease: Change in fluid biomarker
Change from baseline in cerebrospinal fluid (CSF)/plasma p-tau217, p-tau181, Aβ42, GFAP and NfL levels
Time frame: up to 2 years
Alzheimer's disease: Change in Neuropsychiatric Inventory (NPI-Q) Total Severity Score
The NPI-Q is a brief, caregiver-reported assessment of neuropsychiatric symptoms associated with dementia. The NPI-Q yields total scores for Severity and Distress, reflecting the sum of ratings across all domains, with higher scores indicating a greater degree of symptom severity and caregiver distress, respectively.
Time frame: up to 2 years
Alzheimer's disease: Change in Clinical Global Impression
The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is used to assess the severity and progression of AD, where scores from 0 to 7 represent the spectrum of symptom intensity (0 = asymptomatic to 7 = extremely severe). The Efficacy Index (EI), a composite metric balancing therapeutic benefits and side effects, ultimately reflects the efficacy of surgical interventions for AD.
Time frame: up to 2 years
Alzheimer's disease: Changes in the functional connectivity in brain in a subset of participants
Change from baseline in disrupted functional connectivity as measured by functional MRI (fMRI)
Time frame: baseline, 1year, 2 years
Parkinson's disease: Change in fluid biomarker
Change from baseline in cerebrospinal fluid (CSF)/plasma α-synuclein, GFAP, NfL levels
Time frame: up to 2 years
Changes in the hippocampal volume
Change from baseline in hippocampal volume (mm3) as measured by structural Magnetic Resonance Imaging (sMRI)
Time frame: baseline, 1year, 2 years
Changes in the cortical thickness
Change from baseline in cortical thickness (mm) as measured by structural Magnetic Resonance Imaging (sMRI)
Time frame: baseline, 1year, 2 years
Changes in the water diffusion characteristics in brain
Change from baseline in water diffusion reflects the White Matter Hyperintensities (WMH)/efficiency of lymphatic drainage as measured by MRI
Time frame: baseline, 1year, 2 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zhejiang Provincial People's Hospital