AzTrials
AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
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 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.

Xinxin Luo contact

19917731027

1213895523@qq.com

China1 site

  • Zhongshan Third People's Hospital

    Shenzhen

    Xinxin Luo, 19917731027, 1213895523@qq.com

Other trials in China

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:

  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?
Being tested
Lymphaticovenous Anastomosis
Keywords
Lymphaticovenous Anastomosis, cognitive function, therapeutic efficacy, Mechanism, Alzheimer&#39;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 groups in NCT06706947
Study groupRoleWhat they receive
Lymphaticovenous AnastomosisExperimentalNot described
Receives: Procedure: Lymphaticovenous Anastomosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted27 Nov 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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)
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 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 2018 Jul 25.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 35441600

  • Alitalo K. The lymphatic vasculature in disease. Nat Med. 2011 Nov 7;17(11):1371-80. doi: 10.1038/nm.2545.

    PubMed 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.

    PubMed 22896675

  • Zhang 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 23622250

  • Bai 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 32795892

  • Park 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 29950669

  • Mummery 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 37095250

  • Mintun 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 33720637

  • Panza 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 30635926

  • Zhang 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

Questions about this trial

What is this clinical trial studying?

A study testing Lymphaticovenous Anastomosis in people with Alzheimer&amp;#39;s Disease (AD), run by Luo Xinxin 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Nov 2024. 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 Xinxin Luo (19917731027, 1213895523@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mini-Mental State Examination(MMSE) (time frame: half a year). 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 NCT06706947, which also lists 20 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 27 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in