Alzheimer's DiseaseNCT06936514
Clinical Study on Deep Cervical Lymphatic Trunk Decompression Combined With Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for Alzheimer's Disease Treatment
A study testing Bilateral Cervical Deep Lymphatic Trunk Decompression Combined with Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for Alzheimer's Disease in people with Alzheimer's Disease, run by Oriental Neurosurgery Evidence-Based-Study Team at 1 site in China.
Trial summary
The aim of this study is to evaluate the feasibility, safety, and efficacy of bilateral deep cervical lymphatic trunk decompression combined with mid and deep cervical lymph node-extracervical vein anastomosis in the treatment of patients with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Bilateral Cervical Deep Lymphatic Trunk Decompression Combined with Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for Alzheimer's Disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2025to 10 Jul 2026
- 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
- Age 50-80 years;
- Meet the diagnostic criteria for AD in the Revised Criteria for the Diagnosis and Staging of Alzheimer's Disease (2024) published by the National Institute Aging and Alzheimer's Association (NIA-AA);
- Presence of moderate-to-severe cognitive impairment with a Clinical Dementia Rating (CDR) score ≥2, and Mini-Mental State Examination (MMSE) score of < 20;
- Stable use of medication for ≥1 month and no planned change in medication within 3 months of randomisation;
- The patients and their families had been informed of the purpose, significance, expected effects and potential risks of the study and voluntarily participated in the study by providing biological samples and signing an informed consent form.
Who cannot join
- Dementia caused by other reasons: vascular dementia, central nervous system infections (e.g. HIV, syphilis, etc.), Creutzfeldt-Jakob disease, Huntington's chorea and Parkinson's disease, dementia with Lewy bodies, dementia due to traumatic brain injury, other physical and chemical factors (e.g. drug intoxication, alcohol intoxication, carbon monoxide intoxication, etc.), important physical diseases (e.g. hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial occupying lesions (e.g. subdural haematoma, brain tumour), endocrine system lesions (e.g. thyroid disease, parathyroid disease), and vitamin deficiency or any other cause of dementia;
- Presence of current serious or unstable medical conditions, including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological (except for cognitive impairment of AD origin), psychiatric, immunological or haematological disorders, and any other condition which, in the opinion of the investigator, may affect the results of the analyses in this study; or a life expectancy of <24 months;
- Presence of a history of cancer within 5 years, with the exception of non-metastatic basal cell and/or squamous cell carcinoma of the skin, cervical carcinoma in situ, non-progressive prostate cancer, or other cancers with a low risk of recurrence or spread;
- Subjects with a current diagnosis of any primary psychiatric disorder other than cognitive impairment of AD origin, which requires exclusion if, in the opinion of the Investigator, the presence of the psychiatric disorder or symptom may interfere with interpretation of the effects of the LVA, interfere with cognitive assessment, or interfere with the subject's ability to complete the study. Exclusion is required for subjects with a history of schizophrenia or other chronic psychiatric illness;
- Subjects who, in the judgement of the investigator, are actively suicidal and therefore considered to be at significant risk of suicide;
- Illiteracy or insufficient education to complete the scale assessment;
Show all 18Show fewer
- A history of alcohol or drug abuse (other than a history of smoking) in the 2 years prior to the screening visit;
- A clinically significant history of multiple or severe drug allergies, significant atopic sensitivities, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme, linear IgA dermatosis, toxic epidermal necrolysis-relaxation, and/or exfoliative dermatitis);
- Clinically significant abnormalities of clinical significance (as determined by the investigator) on physical or neurological examination, vital signs, ECG, or clinical laboratory findings at screening that may be detrimental to the subject, interfere with the study, or suggest evidence of other causes of dementia;
- MRI results at screening that show evidence of significant abnormalities suggesting the presence of another potential etiology of progressive cognitive impairment or the presence of clinically significant findings which may compromise the subject's ability to safely participate in the study. For example, >2 infarct foci >2 cm in diameter; infarct foci in key areas such as thalamus, hippocampus, internal olfactory cortex, parafactory cortex, angular gyrus, cortex and other subcortical grey matter nuclei; and a Fazekas Scale grade of >2 on the Cerebral White Matter Impairment Scale (CWMIS);
- Presence of any contraindication to MRI, including claustrophobia, or presence of prohibited metallic (ferromagnetic) implants/pacemakers;
- Presence of contraindications to LVA surgery, such as the presence of severe infection at the surgical site, severe cardiac, pulmonary, hepatic, renal, or other systemic functional abnormalities that cannot tolerate general anaesthesia surgery;
- Currently participating in a clinical trial involving other interventional clinical trials, or participating in any other type of medical research that is considered scientifically or medically incompatible with this study;
- Other reasons that prevent completion of this study: e.g., lack of a stable caregiver;
- Female subjects who are pregnant or planning to become pregnant;
- Patients with a Global Deterioration Scale (GDS) score of 7 were excluded, as the profound loss of verbal communication and basic motor function at this stage precluded adherence to study protocols and reliable participation in postoperative assessments.
- is a member of the Research Centre staff and/or his/her immediate family directly related to this study. Immediate family is defined as a spouse, parent, child, or sibling, whether biologically or legally adopted.
- who were currently receiving or had previously received anti-amyloid β disease-modifying therapies (DMTs), or who had participated in clinical trials involving such agents, were not eligible for inclusion.
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
General Hospital of Tianjin Medical University, 154 Anshan Road, Heping District, Tianjin, China
Tianjin
About this study
Official title: Bilateral Cervical Deep Lymphatic Trunk Decompression Combined With Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for the Treatment of Alzheimer's Disease: A Randomized Controlled Clinical Trial
The aim of this study is to evaluate the feasibility, safety, and efficacy of bilateral deep cervical lymphatic trunk decompression combined with mid and deep cervical lymph node-extracervical vein anastomosis in the treatment of patients with Alzheimer's disease. The study seeks to explore new treatment options that may improve the quality of life for patients with Alzheimer's disease.
Read the detailed description
Alzheimer's disease (AD) is a progressive neurodegenerative disorder characterized by memory loss, cognitive impairment, and behavioral changes, ultimately leading to the inability of patients to perform daily activities independently. Despite the availability of various pharmacological treatments aimed at alleviating the progression of the disease, current therapeutic approaches are unable to effectively delay or reverse the course of AD. Therefore, the treatment of Alzheimer's disease remains a significant challenge in the global medical community. This issue is particularly pressing in patients with moderate to severe AD, as existing therapies have limited efficacy, creating a critical need for novel treatment strategies.
The discovery of the brain's lymphatic system has opened new avenues for the treatment of neurodegenerative diseases, including Alzheimer's disease. Recent studies have shown that the meningeal lymphatic vessels play a crucial role in clearing waste products from the brain, including neurotoxins such as amyloid-beta, which accumulate in patients with AD. Dysfunction of this lymphatic drainage system has been implicated in the pathogenesis of Alzheimer's disease. This insight has spurred interest in enhancing lymphatic drainage as a potential therapeutic approach for AD.
Lymphatic-venous anastomosis (LVA) is a surgical technique traditionally used to treat lymphedema and other lymphatic drainage disorders. It involves surgically connecting lymphatic vessels to nearby veins, allowing lymph fluid to flow directly into the venous system. Studies have suggested that LVA may help improve lymphatic drainage in the brain and potentially reduce the accumulation of harmful substances associated with Alzheimer's disease, thereby slowing disease progression. This research aims to provide valuable insights into the potential of enhancing brain lymphatic drainage as a therapeutic strategy for Alzheimer's disease, potentially leading to significant breakthroughs in its treatment.
- Conditions
- Alzheimer's Disease
- Being tested
- Bilateral Cervical Deep Lymphatic Trunk Decompression Combined with Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for Alzheimer's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Cervical Deep Lymphatic Trunk Decompression Combined with Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for Alzheimer's DiseaseProcedure or surgery
This intervention involves a surgical approach that combines bilateral cervical deep lymphatic trunk decompression with mid-cervical deep lymph node-external jugular vein anastomosis (LVA) to enhance lymphatic drainage in Alzheimer's Disease (AD) patients. The aim is to reduce the accumulation of neurotoxic substances in the brain, potentially improving cognitive function by facilitating waste clearance via the lymphatic system. The procedure is intended to restore normal lymphatic flow, potentially slowing disease progression in AD patients who have moderate to severe cognitive impairment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (Surgical group) | Experimental | bilateral cervical deep lymphatic trunk decompression combined with mid-cervical deep lymph node-external jugular vein anastomosis Receives: Procedure: Bilateral Cervical Deep Lymphatic Trunk Decompression Combined with Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for Alzheimer's Disease |
| control group | No intervention | Patients are not subject to surgical intervention, only medication is administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alzheimer's disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13)
The Alzheimer's disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog 13) will be used to evaluate the general cognitive function. ADAS-Cog 13 ranges from 0 to 85, and higher value represents a worse outcome.
Measured: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
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: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
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: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
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: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
Change in Clinical Dementia Rating Scale global score (CDR-GS)
The Clinical Dementia Rating Scale global score (CDR-GS) will be used to evaluate the general cognitive function. CDR-GS ranges from 0 to 3, and higher value represents a worse outcome.
Measured: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
Secondary outcomes (1)
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 and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start8 Jan 2025
- Primary completion10 Jul 2025
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oriental Neurosurgery Evidence-Based-Study Team
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936514
- Sponsor's protocol ID
- IRB2025-YX-099-01
- Status last verified
- Apr 2025
- First submitted
- 22 Mar 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benveniste H, Liu X, Koundal S, Sanggaard S, Lee H, Wardlaw J. The Glymphatic System and Waste Clearance with Brain Aging: A Review. Gerontology. 2019;65(2):106-119. doi: 10.1159/000490349. Epub 2018 Jul 11.
PubMed 29996134Goodman JR, Adham ZO, Woltjer RL, Lund AW, Iliff JJ. Characterization of dural sinus-associated lymphatic vasculature in human Alzheimer's dementia subjects. Brain Behav Immun. 2018 Oct;73:34-40. doi: 10.1016/j.bbi.2018.07.020. Epub 2018 Jul 25.
PubMed 30055243MohanaSundaram A, Mofatteh M, Ashraf GM, Pratico D. Glymphotherapeutics for Alzheimer's disease: Time to move the needle. Ageing Res Rev. 2024 Nov;101:102478. doi: 10.1016/j.arr.2024.102478. Epub 2024 Aug 31.
PubMed 39222666Guo X, Zhang G, Peng Q, Huang L, Zhang Z, Zhang Z. Emerging Roles of Meningeal Lymphatic Vessels in Alzheimer's Disease. J Alzheimers Dis. 2023;94(s1):S355-S366. doi: 10.3233/JAD-221016.
PubMed 36683509Jiang H, Wei H, Zhou Y, Xiao X, Zhou C, Ji X. Overview of the meningeal lymphatic vessels in aging and central nervous system disorders. Cell Biosci. 2022 Dec 17;12(1):202. doi: 10.1186/s13578-022-00942-z.
PubMed 36528776Wu Y, Zhang T, Li X, Wei Y, Li X, Wang S, Liu J, Li D, Wang S, Ye T. Borneol-driven meningeal lymphatic drainage clears amyloid-beta peptide to attenuate Alzheimer-like phenotype in mice. Theranostics. 2023 Jan 1;13(1):106-124. doi: 10.7150/thno.76133. eCollection 2023.
PubMed 36593948Zhang X, Cao R, Zhu C, Yang L, Zheng N, Ji W, Liu P, Chi T, Ji X, Zheng Z, Chen G, Zou L. Mechanism of anti-AD action of OAB-14 by enhancing the function of glymphatic system. Neurochem Int. 2023 Oct 27:105633. doi: 10.1016/j.neuint.2023.105633. Online ahead of print.
PubMed 39491236Chen Y, He X, Cai J, Li Q. Functional aspects of the brain lymphatic drainage system in aging and neurodegenerative diseases. J Biomed Res. 2024 Mar 2;38(3):206-221. doi: 10.7555/JBR.37.20230264.
PubMed 38430054Pu T, Zou W, Feng W, Zhang Y, Wang L, Wang H, Xiao M. Persistent Malfunction of Glymphatic and Meningeal Lymphatic Drainage in a Mouse Model of Subarachnoid Hemorrhage. Exp Neurobiol. 2019 Feb;28(1):104-118. doi: 10.5607/en.2019.28.1.104. Epub 2019 Feb 28.
PubMed 30853828Li G, Cao Y, Tang X, Huang J, Cai L, Zhou L. The meningeal lymphatic vessels and the glymphatic system: Potential therapeutic targets in neurological disorders. J Cereb Blood Flow Metab. 2022 Aug;42(8):1364-1382. doi: 10.1177/0271678X221098145. Epub 2022 Apr 28.
PubMed 35484910Da 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 30046111Aspelund 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 26077718
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Cervical Deep Lymphatic Trunk Decompression Combined With Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for the Treatment of Alzheimer's Disease: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06936514
- Acronym / sponsor ID
- IRB2025-YX-099-01
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Oriental Neurosurgery Evidence-Based-Study TeamUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 20 Apr 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.
The aim of this study is to evaluate the feasibility, safety, and efficacy of bilateral deep cervical lymphatic trunk decompression combined with mid and deep cervical lymph node-extracervical vein anastomosis in the treatment of patients with Alzheimer's disease. The study seeks to explore new treatment options that may improve the quality of life for patients with Alzheimer's disease.
Detailed description
Alzheimer's disease (AD) is a progressive neurodegenerative disorder characterized by memory loss, cognitive impairment, and behavioral changes, ultimately leading to the inability of patients to perform daily activities independently. Despite the availability of various pharmacological treatments aimed at alleviating the progression of the disease, current therapeutic approaches are unable to effectively delay or reverse the course of AD. Therefore, the treatment of Alzheimer's disease remains a significant challenge in the global medical community. This issue is particularly pressing in patients with moderate to severe AD, as existing therapies have limited efficacy, creating a critical need for novel treatment strategies.
The discovery of the brain's lymphatic system has opened new avenues for the treatment of neurodegenerative diseases, including Alzheimer's disease. Recent studies have shown that the meningeal lymphatic vessels play a crucial role in clearing waste products from the brain, including neurotoxins such as amyloid-beta, which accumulate in patients with AD. Dysfunction of this lymphatic drainage system has been implicated in the pathogenesis of Alzheimer's disease. This insight has spurred interest in enhancing lymphatic drainage as a potential therapeutic approach for AD.
Lymphatic-venous anastomosis (LVA) is a surgical technique traditionally used to treat lymphedema and other lymphatic drainage disorders. It involves surgically connecting lymphatic vessels to nearby veins, allowing lymph fluid to flow directly into the venous system. Studies have suggested that LVA may help improve lymphatic drainage in the brain and potentially reduce the accumulation of harmful substances associated with Alzheimer's disease, thereby slowing disease progression. This research aims to provide valuable insights into the potential of enhancing brain lymphatic drainage as a therapeutic strategy for Alzheimer's disease, potentially leading to significant breakthroughs in its treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (Surgical group) | Experimental | Procedure: Bilateral Cervical Deep Lymphatic Trunk Decompression Combined with Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for Alzheimer's Diseasebilateral cervical deep lymphatic trunk decompression combined with mid-cervical deep lymph node-external jugular vein anastomosis |
| control group | No intervention | –Patients are not subject to surgical intervention, only medication is administered |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50-80 years;
- Meet the diagnostic criteria for AD in the Revised Criteria for the Diagnosis and Staging of Alzheimer's Disease (2024) published by the National Institute Aging and Alzheimer's Association (NIA-AA);
- Presence of moderate-to-severe cognitive impairment with a Clinical Dementia Rating (CDR) score ≥2, and Mini-Mental State Examination (MMSE) score of < 20;
- Stable use of medication for ≥1 month and no planned change in medication within 3 months of randomisation;
- The patients and their families had been informed of the purpose, significance, expected effects and potential risks of the study and voluntarily participated in the study by providing biological samples and signing an informed consent form.
Key exclusion criteria (18 listed)
- Dementia caused by other reasons: vascular dementia, central nervous system infections (e.g. HIV, syphilis, etc.), Creutzfeldt-Jakob disease, Huntington's chorea and Parkinson's disease, dementia with Lewy bodies, dementia due to traumatic brain injury, other physical and chemical factors (e.g. drug intoxication, alcohol intoxication, carbon monoxide intoxication, etc.), important physical diseases (e.g. hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial occupying lesions (e.g. subdural haematoma, brain tumour), endocrine system lesions (e.g. thyroid disease, parathyroid disease), and vitamin deficiency or any other cause of dementia;
- Presence of current serious or unstable medical conditions, including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological (except for cognitive impairment of AD origin), psychiatric, immunological or haematological disorders, and any other condition which, in the opinion of the investigator, may affect the results of the analyses in this study; or a life expectancy of <24 months;
- Presence of a history of cancer within 5 years, with the exception of non-metastatic basal cell and/or squamous cell carcinoma of the skin, cervical carcinoma in situ, non-progressive prostate cancer, or other cancers with a low risk of recurrence or spread;
- Subjects with a current diagnosis of any primary psychiatric disorder other than cognitive impairment of AD origin, which requires exclusion if, in the opinion of the Investigator, the presence of the psychiatric disorder or symptom may interfere with interpretation of the effects of the LVA, interfere with cognitive assessment, or interfere with the subject's ability to complete the study. Exclusion is required for subjects with a history of schizophrenia or other chronic psychiatric illness;
- Subjects who, in the judgement of the investigator, are actively suicidal and therefore considered to be at significant risk of suicide;
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 |
|---|---|---|
| Bilateral Cervical Deep Lymphatic Trunk Decompression Combined with Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for Alzheimer's DiseaseThis intervention involves a surgical approach that combines bilateral cervical deep lymphatic trunk decompression with mid-cervical deep lymph node-external jugular vein anastomosis (LVA) to enhance lymphatic drainage in Alzheimer's Disease (AD) patients. The aim is to reduce the accumulation of neurotoxic substances in the brain, potentially improving cognitive function by facilitating waste clearance via the lymphatic system. The procedure is intended to restore normal lymphatic flow, potentially slowing disease progression in AD patients who have moderate to severe cognitive impairment. | Procedure or surgery | Experimental group (Surgical group) |
Primary outcome
Change in Alzheimer's disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13)
Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
The Alzheimer's disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog 13) will be used to evaluate the general cognitive function. ADAS-Cog 13 ranges from 0 to 85, and higher value represents a worse outcome.
Change in Montreal Cognitive Assessment (MoCA)
Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
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.
Change in Mini-mental State Examination (MMSE)
Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
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.
Change in Clinical Dementia Rating Scale sum of the boxes (CDR-SB)
Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
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.
Change in Clinical Dementia Rating Scale global score (CDR-GS)
Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
The Clinical Dementia Rating Scale global score (CDR-GS) will be used to evaluate the general cognitive function. CDR-GS ranges from 0 to 3, and higher value represents a worse outcome.
1 secondary outcome
Change in amyloid deposit in brain
Time frame: Baseline and 3 months after surgery
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 19 Feb 2026.
- Results publication: PubMed 29996134Benveniste H, Liu X, Koundal S, Sanggaard S, Lee H, Wardlaw J. The Glymphatic System and Waste Clearance with Brain Aging: A Review. Gerontology. 2019;65(2):106-119. doi: 10.1159/000490349. Epub 2018 Jul 11.
- Results publication: PubMed 30055243Goodman JR, Adham ZO, Woltjer RL, Lund AW, Iliff JJ. Characterization of dural sinus-associated lymphatic vasculature in human Alzheimer's dementia subjects. Brain Behav Immun. 2018 Oct;73:34-40. doi: 10.1016/j.bbi.2018.07.020. Epub 2018 Jul 25.
- Results publication: PubMed 39222666MohanaSundaram A, Mofatteh M, Ashraf GM, Pratico D. Glymphotherapeutics for Alzheimer's disease: Time to move the needle. Ageing Res Rev. 2024 Nov;101:102478. doi: 10.1016/j.arr.2024.102478. Epub 2024 Aug 31.
- Results publication: PubMed 36683509Guo X, Zhang G, Peng Q, Huang L, Zhang Z, Zhang Z. Emerging Roles of Meningeal Lymphatic Vessels in Alzheimer's Disease. J Alzheimers Dis. 2023;94(s1):S355-S366. doi: 10.3233/JAD-221016.
- Results publication: PubMed 36528776Jiang H, Wei H, Zhou Y, Xiao X, Zhou C, Ji X. Overview of the meningeal lymphatic vessels in aging and central nervous system disorders. Cell Biosci. 2022 Dec 17;12(1):202. doi: 10.1186/s13578-022-00942-z.
- Results publication: PubMed 36593948Wu Y, Zhang T, Li X, Wei Y, Li X, Wang S, Liu J, Li D, Wang S, Ye T. Borneol-driven meningeal lymphatic drainage clears amyloid-beta peptide to attenuate Alzheimer-like phenotype in mice. Theranostics. 2023 Jan 1;13(1):106-124. doi: 10.7150/thno.76133. eCollection 2023.
- Results publication: PubMed 39491236Zhang X, Cao R, Zhu C, Yang L, Zheng N, Ji W, Liu P, Chi T, Ji X, Zheng Z, Chen G, Zou L. Mechanism of anti-AD action of OAB-14 by enhancing the function of glymphatic system. Neurochem Int. 2023 Oct 27:105633. doi: 10.1016/j.neuint.2023.105633. Online ahead of print.
- Results publication: PubMed 38430054Chen Y, He X, Cai J, Li Q. Functional aspects of the brain lymphatic drainage system in aging and neurodegenerative diseases. J Biomed Res. 2024 Mar 2;38(3):206-221. doi: 10.7555/JBR.37.20230264.
- Results publication: PubMed 30853828Pu T, Zou W, Feng W, Zhang Y, Wang L, Wang H, Xiao M. Persistent Malfunction of Glymphatic and Meningeal Lymphatic Drainage in a Mouse Model of Subarachnoid Hemorrhage. Exp Neurobiol. 2019 Feb;28(1):104-118. doi: 10.5607/en.2019.28.1.104. Epub 2019 Feb 28.
- Results publication: PubMed 35484910Li G, Cao Y, Tang X, Huang J, Cai L, Zhou L. The meningeal lymphatic vessels and the glymphatic system: Potential therapeutic targets in neurological disorders. J Cereb Blood Flow Metab. 2022 Aug;42(8):1364-1382. doi: 10.1177/0271678X221098145. Epub 2022 Apr 28.
- 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.
- 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.
- Individual participant dataSharing planned: No
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Alzheimer Disease, Alzheimer Disease (AD)
RecruitingObservational study
Multimodal Ophthalmic Imaging and Plasma Biomarkers for the Early Detection of Alzheimer's Disease
Alzheimer's Disease (AD)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Cervical Deep Lymphatic Trunk Decompression Combined with Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for Alzheimer's Disease in people with Alzheimer's Disease, run by Oriental Neurosurgery Evidence-Based-Study Team 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 5 inclusion and 18 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: enrolling by invitation, as of the sponsor's last update on 19 Feb 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alzheimer's disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) (time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.). The study lists 5 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 NCT06936514, which also lists 12 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 19 Feb 2026; AzTrials last refreshed its copy on 4 Nov 2026.