Exploration of the Efficacy and Mechanisms of Lymphaticovenous Anastomosis in the Treatment of Alzheimer's Disease

Обзор

The aim of this clinical trial is to determine whether Lymphaticovenous Anastomosis can treat Alzheimer's disease，in AD patients aged 18-80.he main questions it aims to answer are: 1. Can Lymphaticovenous Anastomosis improve cognitive function, daily living ability, mood, or sleep status in patients with Alzheimer's dementia, demonstrating good therapeutic efficacy? 2. Does deep Lymphaticovenous Anastomosis lead to changes in peripheral blood biomarker levels, neuroinflammatory responses, and neuroimaging in patients with Alzheimer's dementia?

Вмешательства

• Процедура Lymphaticovenous Anastomosis
  Lymphaticovenous Anastomosis (LVA) is an emerging super-microsurgical procedure pioneered by Professor Xie Qingping and his team, a group of Chinese microsurgery experts. This technique has been published in the official journal of the American Society of Plastic Surgeons (ASPS), confirming its effectiveness in improving the "drainage" function of the brain and reducing lymphatic pressure in deep brain tissues. By establishing an anastomosis between lymphatic vessels and veins in the neck, the s

Первичные конечные точки

• Mini-Mental State Examination(MMSE) [Срок оценки: half a year]

Критерии участия

Критерии включения

• At least two deputy chief physicians or above, diagnosed with Alzheimer's dementia according to the DSM-5 diagnostic criteria;
• Age between 18-80 years old;
• The course of the disease is at least 1 year;
• MMSE score ≤ 24 points; MoCA score < 26
• Brain MRI shows hippocampal atrophy;
• Patients and their families agree to participate in this project for surgical treatment and sign an informed consent form.

Критерии исключения

• Individuals with contraindications for Lymphaticovenous Anastomosis; those allergic to anesthetics and contrast agents (indocyanine green);
• Those unable to cooperate with cranial magnetic resonance imaging and scale testing;
• Patients simultaneously suffering from schizophrenia, depression, bipolar disorder;
• Patients with severe somatic diseases (such as cardiovascular, liver, kidney, gastrointestinal, etc.), infectious diseases, and immune system disorders;
• Individuals with serious neurological diseases (such as epilepsy, cerebrovascular diseases, etc.), other types of dementia, mental retardation;
• Pregnant or lactating women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan Third People's Hospital — Шэньчжэнь

Публикации

• Waldemar G, Phung KT, Burns A, Georges J, Hansen FR, Iliffe S, Marking C, Rikkert MO, Selmes J, Stoppe G, Sartorius N. Access to diagnostic evaluation and treatment for dementia in Europe. Int J Geriatr Psychiatry. 2007 Jan;22(1):47-54. doi: 10.1002/gps.1652. PMID 17044135
• 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 2 PMID 30046111
• Aspelund 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. PMID 26077718
• Louveau 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. PMID 26030524
• Olate-Briones A, Escalona E, Salazar C, Herrada MJ, Liu C, Herrada AA, Escobedo N. The meningeal lymphatic vasculature in neuroinflammation. FASEB J. 2022 May;36(5):e22276. doi: 10.1096/fj.202101574RR. PMID 35344212
• Busch N, O'Reilly L, Louveau A. Meningeal Lymphatic vasculature in health and disease. Curr Opin Hematol. 2022 May 1;29(3):151-155. doi: 10.1097/MOH.0000000000000711. Epub 2022 Feb 18. PMID 35441600
• Alitalo K. The lymphatic vasculature in disease. Nat Med. 2011 Nov 7;17(11):1371-80. doi: 10.1038/nm.2545. PMID 22064427
• Iliff 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. PMID 22896675

Идентификаторы

NCT: NCT06706947 · SSYLL-KY-20241002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗