Alzheimer DiseaseSOLVENNCT06852352
An Exploratory Study to Confirm Efficacy of Modified Deep Cervical Lymphovenous Anastomosis (LVA) in Alzheimer's Disease/ Parkinson's Disease
A study testing Modified deep cervical Lymphatic-Venous Anastomosis in people with Alzheimer Disease and Parkinson Disease, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease, Parkinson Disease
- What is being tested?
- Modified deep cervical Lymphatic-Venous Anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2025to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- Contraindications for MRI, ICG angiography, or PET scanning
- Contraindications for lumbar puncture
- 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
- 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;
- Poorly controlled thyroid dysfunction;
Show all 17Show fewer
- Cerebrovascular or systemic vasculopathy;
- 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;
- Chronic hypnotic use (more than twice weekly for over one month);
- History of untreated/uncured malignancies;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Youmao Zheng, MM, +86-571-85335800, Zhengym6228@gmail.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Alzheimer Disease, Parkinson Disease
- Being tested
- Modified deep cervical Lymphatic-Venous Anastomosis
- Keywords
- LVA
- Medical subject headings
- Alzheimer Disease, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified deep cervical Lymphatic-Venous AnastomosisProcedure or surgery
Deep cervical lymph-vein anastomosis surgery, connecting deep cervical lymph input vein vessels to enhance glymphatic-mediated protein clearance
| Study group | Role | What they receive |
|---|---|---|
| The clinically diagnosed patients with MCI or mild-moderate dementia caused by AD/PD | Experimental | Not described Receives: Procedure: Modified deep cervical Lymphatic-Venous Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 2 years
Secondary outcomes (10)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: baseline, 1year, 2 years
Parkinson's disease: Change in fluid biomarker
Change from baseline in cerebrospinal fluid (CSF)/plasma α-synuclein, GFAP, NfL levels
Measured: up to 2 years
Changes in the hippocampal volume
Change from baseline in hippocampal volume (mm3) as measured by structural Magnetic Resonance Imaging (sMRI)
Measured: baseline, 1year, 2 years
Changes in the cortical thickness
Change from baseline in cortical thickness (mm) as measured by structural Magnetic Resonance Imaging (sMRI)
Measured: 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
Measured: baseline, 1year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start28 Feb 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zybio Inc.
- Responsible party
- Principal investigator, Youmao Zheng, MM, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852352
- Sponsor's protocol ID
- KY2025008
- Acronym
- SOLVEN
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Y, Wang L, Zhong J, Xu H, Han Y; Alzheimer's Disease Neuroimaging Initiative; Zuo C, Jiang J. Impaired glymphatic function as a biomarker for subjective cognitive decline: An exploratory dual cohort study. Alzheimers Dement. 2024 Sep;20(9):6542-6555. doi: 10.1002/alz.14149. Epub 2024 Aug 6.
PubMed 39107995Huang SY, Zhang YR, Guo Y, Du J, Ren P, Wu BS, Feng JF; Alzheimer's Disease Neuroimaging Initiative; Cheng W, Yu JT. Glymphatic system dysfunction predicts amyloid deposition, neurodegeneration, and clinical progression in Alzheimer's disease. Alzheimers Dement. 2024 May;20(5):3251-3269. doi: 10.1002/alz.13789. Epub 2024 Mar 19.
PubMed 38501315Pappolla M, Sambamurti K, Vidal R, Pacheco-Quinto J, Poeggeler B, Matsubara E. Evidence for lymphatic Abeta clearance in Alzheimer's transgenic mice. Neurobiol Dis. 2014 Nov;71:215-9. doi: 10.1016/j.nbd.2014.07.012. Epub 2014 Aug 4.
PubMed 25102344Nedergaard M, Goldman SA. Glymphatic failure as a final common pathway to dementia. Science. 2020 Oct 2;370(6512):50-56. doi: 10.1126/science.abb8739.
PubMed 33004510Iliff JJ, Wang M, Liao Y, Plogg BA, Peng W, Gundersen GA, Benveniste H, Vates GE, Deane R, Goldman SA, Nagelhus EA, Nedergaard M. A paravascular pathway facilitates CSF flow through the brain parenchyma and the clearance of interstitial solutes, including amyloid beta. Sci Transl Med. 2012 Aug 15;4(147):147ra111. doi: 10.1126/scitranslmed.3003748.
PubMed 22896675Aspelund A, Antila S, Proulx ST, Karlsen TV, Karaman S, Detmar M, Wiig H, Alitalo K. A dural lymphatic vascular system that drains brain interstitial fluid and macromolecules. J Exp Med. 2015 Jun 29;212(7):991-9. doi: 10.1084/jem.20142290. Epub 2015 Jun 15.
PubMed 26077718Chen F, Xie X, Wang L. Research Progress on Intracranial Lymphatic Circulation and Its Involvement in Disorders. Front Neurol. 2022 Mar 14;13:865714. doi: 10.3389/fneur.2022.865714. eCollection 2022.
PubMed 35359624Zhao H, Sun M, Zhang Y, Kong W, Fan L, Wang K, Xu Q, Chen B, Dong J, Shi Y, Wang Z, Wang S, Zhuang X, Li Q, Lin F, Yao X, Zhang W, Kong C, Zhang R, Feng D, Zhao X. Connecting the Dots: The Cerebral Lymphatic System as a Bridge Between the Central Nervous System and Peripheral System in Health and Disease. Aging Dis. 2024 Feb 1;15(1):115-152. doi: 10.14336/AD.2023.0516.
PubMed 37307828Vera Quesada CL, Rao SB, Torp R, Eide PK. Immunohistochemical visualization of lymphatic vessels in human dura mater: methodological perspectives. Fluids Barriers CNS. 2023 Mar 28;20(1):23. doi: 10.1186/s12987-023-00426-3.
PubMed 36978127Louveau A, Smirnov I, Keyes TJ, Eccles JD, Rouhani SJ, Peske JD, Derecki NC, Castle D, Mandell JW, Lee KS, Harris TH, Kipnis J. Structural and functional features of central nervous system lymphatic vessels. Nature. 2015 Jul 16;523(7560):337-41. doi: 10.1038/nature14432. Epub 2015 Jun 1.
PubMed 26030524Da Mesquita S, Louveau A, Vaccari A, Smirnov I, Cornelison RC, Kingsmore KM, Contarino C, Onengut-Gumuscu S, Farber E, Raper D, Viar KE, Powell RD, Baker W, Dabhi N, Bai R, Cao R, Hu S, Rich SS, Munson JM, Lopes MB, Overall CC, Acton ST, Kipnis J. Functional aspects of meningeal lymphatics in ageing and Alzheimer's disease. Nature. 2018 Aug;560(7717):185-191. doi: 10.1038/s41586-018-0368-8. Epub 2018 Jul 25.
PubMed 30046111
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06852352
- Acronym / sponsor ID
- SOLVEN / KY2025008
- Conditions
- Alzheimer Disease, Parkinson Disease
- Keywords
- LVA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Zybio Inc.
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The clinically diagnosed patients with MCI or mild-moderate dementia caused by AD/PD | Experimental | Procedure: Modified deep cervical Lymphatic-Venous Anastomosis |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (17 listed)
- Contraindications for MRI, ICG angiography, or PET scanning
- Contraindications for lumbar puncture
- 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
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified deep cervical Lymphatic-Venous AnastomosisDeep cervical lymph-vein anastomosis surgery, connecting deep cervical lymph input vein vessels to enhance glymphatic-mediated protein clearance | Procedure or surgery | The clinically diagnosed patients with MCI or mild-moderate dementia caused by AD/PD |
Primary outcome
Alzheimer's disease: Change in Clinical Dementia Rating Scale sum of the boxes (CDR-SB)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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.
10 secondary outcomes
Alzheimer's disease: Change in amyloid deposit in brain
Time frame: baseline, 1year, 2 years
Alzheimer's disease: Change in brain Tau deposition in a subset of participants
Time frame: baseline, 1year, 2 years
Alzheimer's disease: Change in fluid biomarker
Time frame: up to 2 years
Alzheimer's disease: Change in Neuropsychiatric Inventory (NPI-Q) Total Severity Score
Time frame: up to 2 years
Alzheimer's disease: Change in Clinical Global Impression
Time frame: up to 2 years
Alzheimer's disease: Changes in the functional connectivity in brain in a subset of participants
Time frame: baseline, 1year, 2 years
Parkinson's disease: Change in fluid biomarker
Time frame: up to 2 years
Changes in the hippocampal volume
Time frame: baseline, 1year, 2 years
Changes in the cortical thickness
Time frame: baseline, 1year, 2 years
Changes in the water diffusion characteristics in brain
Time frame: baseline, 1year, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Results publication: PubMed 39107995Li Y, Wang L, Zhong J, Xu H, Han Y; Alzheimer's Disease Neuroimaging Initiative; Zuo C, Jiang J. Impaired glymphatic function as a biomarker for subjective cognitive decline: An exploratory dual cohort study. Alzheimers Dement. 2024 Sep;20(9):6542-6555. doi: 10.1002/alz.14149. Epub 2024 Aug 6.
- Results publication: PubMed 38501315Huang SY, Zhang YR, Guo Y, Du J, Ren P, Wu BS, Feng JF; Alzheimer's Disease Neuroimaging Initiative; Cheng W, Yu JT. Glymphatic system dysfunction predicts amyloid deposition, neurodegeneration, and clinical progression in Alzheimer's disease. Alzheimers Dement. 2024 May;20(5):3251-3269. doi: 10.1002/alz.13789. Epub 2024 Mar 19.
- Results publication: PubMed 25102344Pappolla M, Sambamurti K, Vidal R, Pacheco-Quinto J, Poeggeler B, Matsubara E. Evidence for lymphatic Abeta clearance in Alzheimer's transgenic mice. Neurobiol Dis. 2014 Nov;71:215-9. doi: 10.1016/j.nbd.2014.07.012. Epub 2014 Aug 4.
- Results publication: PubMed 33004510Nedergaard M, Goldman SA. Glymphatic failure as a final common pathway to dementia. Science. 2020 Oct 2;370(6512):50-56. doi: 10.1126/science.abb8739.
- Results publication: PubMed 22896675Iliff JJ, Wang M, Liao Y, Plogg BA, Peng W, Gundersen GA, Benveniste H, Vates GE, Deane R, Goldman SA, Nagelhus EA, Nedergaard M. A paravascular pathway facilitates CSF flow through the brain parenchyma and the clearance of interstitial solutes, including amyloid beta. Sci Transl Med. 2012 Aug 15;4(147):147ra111. doi: 10.1126/scitranslmed.3003748.
- Results publication: PubMed 26077718Aspelund A, Antila S, Proulx ST, Karlsen TV, Karaman S, Detmar M, Wiig H, Alitalo K. A dural lymphatic vascular system that drains brain interstitial fluid and macromolecules. J Exp Med. 2015 Jun 29;212(7):991-9. doi: 10.1084/jem.20142290. Epub 2015 Jun 15.
- Results publication: PubMed 35359624Chen F, Xie X, Wang L. Research Progress on Intracranial Lymphatic Circulation and Its Involvement in Disorders. Front Neurol. 2022 Mar 14;13:865714. doi: 10.3389/fneur.2022.865714. eCollection 2022.
- Results publication: PubMed 37307828Zhao H, Sun M, Zhang Y, Kong W, Fan L, Wang K, Xu Q, Chen B, Dong J, Shi Y, Wang Z, Wang S, Zhuang X, Li Q, Lin F, Yao X, Zhang W, Kong C, Zhang R, Feng D, Zhao X. Connecting the Dots: The Cerebral Lymphatic System as a Bridge Between the Central Nervous System and Peripheral System in Health and Disease. Aging Dis. 2024 Feb 1;15(1):115-152. doi: 10.14336/AD.2023.0516.
- Results publication: PubMed 36978127Vera Quesada CL, Rao SB, Torp R, Eide PK. Immunohistochemical visualization of lymphatic vessels in human dura mater: methodological perspectives. Fluids Barriers CNS. 2023 Mar 28;20(1):23. doi: 10.1186/s12987-023-00426-3.
- Results publication: PubMed 26030524Louveau A, Smirnov I, Keyes TJ, Eccles JD, Rouhani SJ, Peske JD, Derecki NC, Castle D, Mandell JW, Lee KS, Harris TH, Kipnis J. Structural and functional features of central nervous system lymphatic vessels. Nature. 2015 Jul 16;523(7560):337-41. doi: 10.1038/nature14432. Epub 2015 Jun 1.
- Results publication: PubMed 30046111Da Mesquita S, Louveau A, Vaccari A, Smirnov I, Cornelison RC, Kingsmore KM, Contarino C, Onengut-Gumuscu S, Farber E, Raper D, Viar KE, Powell RD, Baker W, Dabhi N, Bai R, Cao R, Hu S, Rich SS, Munson JM, Lopes MB, Overall CC, Acton ST, Kipnis J. Functional aspects of meningeal lymphatics in ageing and Alzheimer's disease. Nature. 2018 Aug;560(7717):185-191. doi: 10.1038/s41586-018-0368-8. Epub 2018 Jul 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified deep cervical Lymphatic-Venous Anastomosis in people with Alzheimer Disease and Parkinson Disease, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youmao Zheng (+86-571-85335800, Zhengym6228@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's disease: Change in Clinical Dementia Rating Scale sum of the boxes (CDR-SB) (time frame: up to 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06852352, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.