Alzheimer's Disease (AD)NCT06706947
Exploration of the Efficacy and Mechanisms of Lymphaticovenous Anastomosis in the Treatment of Alzheimer's Disease
A study testing Lymphaticovenous Anastomosis in people with Alzheimer's Disease (AD), run by Luo Xinxin at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alzheimer's Disease (AD)
- What is being tested?
- Lymphaticovenous Anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Interventional
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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
Zhongshan Third People's Hospital
Shenzhen
Xinxin Luo, 19917731027, 1213895523@qq.com
About this study
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:
- Can Lymphaticovenous Anastomosis improve cognitive function, daily living ability, mood, or sleep status in patients with Alzheimer's dementia, demonstrating good therapeutic efficacy?
- Does deep Lymphaticovenous Anastomosis lead to changes in peripheral blood biomarker levels, neuroinflammatory responses, and neuroimaging in patients with Alzheimer's dementia?
- Conditions
- Alzheimer&#39;s Disease (AD)
- Being tested
- Lymphaticovenous Anastomosis
- Keywords
- Lymphaticovenous Anastomosis, cognitive function, therapeutic efficacy, Mechanism, Alzheimer's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphaticovenous AnastomosisProcedure or surgery
Also called LVA
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 surgery enhances the drainage of cerebrospinal fluid, alleviating the accumulation of toxins and waste within the brain, thereby easing the symptoms of Alzheimer's disease. Due to its significant contribution to the field of microsurgery, this innovative surgery has been selected as one of the "Top Seven Advances in Microsurgery for 2022."
| Study group | Role | What they receive |
|---|---|---|
| Lymphaticovenous Anastomosis | Experimental | Not described Receives: Procedure: Lymphaticovenous Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination(MMSE)
Measured: half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Alzheimer&#39;s Disease (AD)Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luo Xinxin
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Baoan District People's Hospital, Shenzhen Kangning Hospital
- Responsible party
- Sponsor-investigator, Luo Xinxin, Zhongshan Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706947
- Sponsor's protocol ID
- SSYLL-KY-20241002
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17044135Da 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 26077718Louveau 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 26030524Olate-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.
PubMed 35344212Busch 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.
PubMed 35441600Alitalo K. The lymphatic vasculature in disease. Nat Med. 2011 Nov 7;17(11):1371-80. doi: 10.1038/nm.2545.
PubMed 22064427Iliff 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 22896675Zhang B, Gaiteri C, Bodea LG, Wang Z, McElwee J, Podtelezhnikov AA, Zhang C, Xie T, Tran L, Dobrin R, Fluder E, Clurman B, Melquist S, Narayanan M, Suver C, Shah H, Mahajan M, Gillis T, Mysore J, MacDonald ME, Lamb JR, Bennett DA, Molony C, Stone DJ, Gudnason V, Myers AJ, Schadt EE, Neumann H, Zhu J, Emilsson V. Integrated systems approach identifies genetic nodes and networks in late-onset Alzheimer's disease. Cell. 2013 Apr 25;153(3):707-20. doi: 10.1016/j.cell.2013.03.030.
PubMed 23622250Bai Y, Ma X. Chlorzoxazone exhibits neuroprotection against Alzheimer's disease by attenuating neuroinflammation and neurodegeneration in vitro and in vivo. Int Immunopharmacol. 2020 Nov;88:106790. doi: 10.1016/j.intimp.2020.106790. Epub 2020 Aug 11.
PubMed 32795892Park J, Wetzel I, Marriott I, Dreau D, D'Avanzo C, Kim DY, Tanzi RE, Cho H. A 3D human triculture system modeling neurodegeneration and neuroinflammation in Alzheimer's disease. Nat Neurosci. 2018 Jul;21(7):941-951. doi: 10.1038/s41593-018-0175-4. Epub 2018 Jun 27.
PubMed 29950669Mummery CJ, Borjesson-Hanson A, Blackburn DJ, Vijverberg EGB, De Deyn PP, Ducharme S, Jonsson M, Schneider A, Rinne JO, Ludolph AC, Bodenschatz R, Kordasiewicz H, Swayze EE, Fitzsimmons B, Mignon L, Moore KM, Yun C, Baumann T, Li D, Norris DA, Crean R, Graham DL, Huang E, Ratti E, Bennett CF, Junge C, Lane RM. Tau-targeting antisense oligonucleotide MAPTRx in mild Alzheimer's disease: a phase 1b, randomized, placebo-controlled trial. Nat Med. 2023 Jun;29(6):1437-1447. doi: 10.1038/s41591-023-02326-3. Epub 2023 Apr 24.
PubMed 37095250Mintun MA, Lo AC, Duggan Evans C, Wessels AM, Ardayfio PA, Andersen SW, Shcherbinin S, Sparks J, Sims JR, Brys M, Apostolova LG, Salloway SP, Skovronsky DM. Donanemab in Early Alzheimer's Disease. N Engl J Med. 2021 May 6;384(18):1691-1704. doi: 10.1056/NEJMoa2100708. Epub 2021 Mar 13.
PubMed 33720637Panza F, Lozupone M, Seripa D, Imbimbo BP. Amyloid-beta immunotherapy for alzheimer disease: Is it now a long shot? Ann Neurol. 2019 Mar;85(3):303-315. doi: 10.1002/ana.25410. Epub 2019 Jan 28.
PubMed 30635926Zhang ZX, Zahner GE, Roman GC, Liu XH, Wu CB, Hong Z, Hong X, Tang MN, Zhou B, Qu QM, Zhang XJ, Li H. Socio-demographic variation of dementia subtypes in china: Methodology and results of a prevalence study in Beijing, Chengdu, Shanghai, and Xian. Neuroepidemiology. 2006;27(4):177-87. doi: 10.1159/000096131. Epub 2006 Oct 11.
PubMed 17035714