Clinical Study on Lymphaticovenous Anastomosis(LVA) for the Treatment of Alzheimer's Disease(AD)
NCT ID: NCT06918145
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
80 participants
INTERVENTIONAL
2025-04-02
2030-03-01
Brief Summary
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1. After LVA surgery treatment, do patients with AD show improvement in dementia, cognitive impairment, neurobehavioral symptoms?
2. What are the complications associated with LVA treatment for AD, including perioperative complications and long-term complications?
3. What is the mechanism of LVA treatment for AD patients, and what changes occur in AD-related biomarkers (Aβ42、 Aβ40、Aβ42/40、pTau217、pTau181) before and after surgery?
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lymphaticovenous Anastomosis(LVA) for the Treatment of Alzheimer's Disease(AD)
Lymphaticovenous Anastomosis
The basic principle of LVA surgery is to anastomose the deep cervical lymphatic vessels of the brain with adjacent small veins, effectively enabling the direct reflow of accumulated Aβ and tau proteins in the brain's lymphatic circulation into the venous system, thereby improving the symptoms of Alzheimer's Disease (AD).
Interventions
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Lymphaticovenous Anastomosis
The basic principle of LVA surgery is to anastomose the deep cervical lymphatic vessels of the brain with adjacent small veins, effectively enabling the direct reflow of accumulated Aβ and tau proteins in the brain's lymphatic circulation into the venous system, thereby improving the symptoms of Alzheimer's Disease (AD).
Eligibility Criteria
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Inclusion Criteria
2. Male or female aged 50-85 years (inclusive);
3. At least one caregiver who can live with the patient for an extended period;
4. No severe systemic diseases affecting the heart, liver, kidneys, etc.;
5. Patients who voluntarily participate in clinical recruitment, accept the LVA surgical treatment plan, and sign the informed consent form.
Exclusion Criteria
2. Preoperative anesthetic assessment indicates inability to tolerate general anesthesia;
3. Presence of other neurological or psychiatric disorders;
4. Severe bleeding tendency due to coagulopathy;
5. Inability to comply with treatment and follow-up;
6. Other conditions that preclude tolerance to surgery.
50 Years
85 Years
ALL
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Locations
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Peking university third hospital
Beijing, Beijing Municipality, China
Countries
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References
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Formolo DA, Yu J, Lin K, Tsang HWH, Ou H, Kranz GS, Yau SY. Leveraging the glymphatic and meningeal lymphatic systems as therapeutic strategies in Alzheimer's disease: an updated overview of nonpharmacological therapies. Mol Neurodegener. 2023 Apr 20;18(1):26. doi: 10.1186/s13024-023-00618-3.
Harrison IF, Ismail O, Machhada A, Colgan N, Ohene Y, Nahavandi P, Ahmed Z, Fisher A, Meftah S, Murray TK, Ottersen OP, Nagelhus EA, O'Neill MJ, Wells JA, Lythgoe MF. Impaired glymphatic function and clearance of tau in an Alzheimer's disease model. Brain. 2020 Aug 1;143(8):2576-2593. doi: 10.1093/brain/awaa179.
Da 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.
Huang 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.
Chachaj A, Gasiorowski K, Szuba A, Sieradzki A, Leszek J. The Lymphatic System In The Brain Clearance Mechanisms - New Therapeutic Perspectives For Alzheimer's Disease. Curr Neuropharmacol. 2023;21(2):380-391. doi: 10.2174/1570159X20666220411091332.
Scheltens P, Blennow K, Breteler MM, de Strooper B, Frisoni GB, Salloway S, Van der Flier WM. Alzheimer's disease. Lancet. 2016 Jul 30;388(10043):505-17. doi: 10.1016/S0140-6736(15)01124-1. Epub 2016 Feb 24.
Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.
Jia L, Du Y, Chu L, Zhang Z, Li F, Lyu D, Li Y, Li Y, Zhu M, Jiao H, Song Y, Shi Y, Zhang H, Gong M, Wei C, Tang Y, Fang B, Guo D, Wang F, Zhou A, Chu C, Zuo X, Yu Y, Yuan Q, Wang W, Li F, Shi S, Yang H, Zhou C, Liao Z, Lv Y, Li Y, Kan M, Zhao H, Wang S, Yang S, Li H, Liu Z, Wang Q, Qin W, Jia J; COAST Group. Prevalence, risk factors, and management of dementia and mild cognitive impairment in adults aged 60 years or older in China: a cross-sectional study. Lancet Public Health. 2020 Dec;5(12):e661-e671. doi: 10.1016/S2468-2667(20)30185-7.
Other Identifiers
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IRB00006761-M20250166
Identifier Type: -
Identifier Source: org_study_id
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