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Cervical Lymphatic Microsurgery in Alzheimer's Disease

5. oktober 2026 opdateret af: Daniel Maliszewski

Microsurgical Modification of Cervical Lymphatic Pathways in Alzheimer's Disease: A Pilot Study

This pilot study will evaluate whether microsurgical modification of cervical lymphatic drainage may influence blood biomarkers and clinical outcomes in people with mild Alzheimer's disease.

Thirty participants will be randomly assigned in a 1:1 ratio to either a surgical intervention group or a control group. Participants in the intervention group will undergo supermicrosurgical lymphaticovenous anastomosis (LVA) and/or lymph node-to-vein anastomosis (LNVA) in the neck to create an alternative pathway for lymphatic drainage. The procedure may be performed manually or with robotic microsurgical assistance. Participants in the control group will receive clinical observation without surgery during the first 12 months.

The primary objective is to assess the change in plasma phosphorylated tau 217 (p-tau217) from baseline to 12 months. The study will also assess changes in cognitive and functional measures, including the Clinical Dementia Rating Sum of Boxes (CDR-SB), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Montreal Cognitive Assessment (MoCA), and Mini-Mental State Examination (MMSE), as well as the feasibility and safety of the surgical procedure.

Participants will be assessed at baseline and at 3, 6, and 12 months. After completion of the 12-month observation period, participants in the control group may be offered the surgical procedure if they wish to undergo it.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Polen
      • Gdansk, Polen, 80-952
        • Rekruttering
        • Uniwersyteckie Centrum Kliniczne w Gdańsku
        • Kontakt:
        • Ledende efterforsker:
          • Kamil Chwojnicki, MD, PhD
      • Słupsk, Polen, 76-200
        • Rekruttering
        • Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
        • Kontakt:
        • Ledende efterforsker:
          • Daniel Maliszewski, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18 years or older
  • Clinical diagnosis of mild Alzheimer's disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
  • Clinical Dementia Rating (CDR) score of 0.5 to 1.0.
  • Mini-Mental State Examination (MMSE) score of 20 to 26.
  • Confirmation of Alzheimer's disease pathology using plasma biomarkers, with elevated phosphorylated tau 217 (p-tau217).
  • Stable pharmacological treatment for Alzheimer's disease for at least 3 months before enrollment.
  • Ability to provide informed consent or consent provided by a legally authorized representative.

Exclusion Criteria:

  • Moderate or severe Alzheimer's disease.
  • Other neurodegenerative disorders or significant psychiatric disorders.
  • Previous major neck surgery or radiotherapy to the neck that may affect lymphatic drainage.
  • Contraindications to general anesthesia.
  • Active infection or coagulation disorders.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Surgical Intervention

Participants assigned to this arm will undergo supermicrosurgical modification of cervical lymphatic drainage using lymphaticovenous anastomosis (LVA) and/or lymph node-to-vein anastomosis (LNVA). The procedure may be performed manually or with robotic microsurgical assistance.
Procedure: Cervical Lymphatic Microsurgery

Supermicrosurgical modification of cervical lymphatic drainage by creation of lymphaticovenous anastomosis (LVA) and/or lymph node-to-vein anastomosis (LNVA). Preoperative lymphatic and venous mapping is performed using ultra-high-frequency ultrasound and indocyanine green fluorescence imaging. The procedure is performed under general anesthesia and may be carried out manually or with robotic supermicrosurgical assistance. The specific anastomotic technique and configuration are selected according to the identified lymphatic and venous anatomy.

Andre navne:
  • Lymph Node-to-Vein Anastomosis (LNVA)
  • Lymphaticovenous Anastomosis (LVA)
Ingen indgriben: Control

Participants assigned to this arm will undergo clinical observation without surgical intervention during the first 12 months. After completion of the 12-month observation period, participants may elect to undergo the surgical procedure.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Plasma Phosphorylated Tau 217 (p-tau217) Concentration From Baseline to Month 12
Tidsramme: Baseline to Month 12

Change in plasma phosphorylated tau 217 (p-tau217) concentration from baseline to the 12-month follow-up. The change over time will be compared between the surgical intervention and control groups.
Baseline to Month 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in CDR-SB Score From Baseline to Month 12
Tidsramme: Baseline to Month 12

The Clinical Dementia Rating Sum of Boxes (CDR-SB) score ranges from 0 to 18, with higher scores indicating greater cognitive and functional impairment and therefore a worse clinical outcome. Change in CDR-SB score from baseline to Month 12 will be compared between the surgical intervention and control groups. A positive change from baseline indicates worsening, whereas a negative change indicates improvement.
Baseline to Month 12
Change in ADCS-ADL Score From Baseline to Month 12
Tidsramme: Baseline to Month 12

The 23-item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) total score ranges from 0 to 78, with higher scores indicating better performance in activities of daily living and therefore a better functional outcome. Change in ADCS-ADL total score from baseline to Month 12 will be compared between the surgical intervention and control groups. A positive change from baseline indicates improvement, whereas a negative change indicates worsening.
Baseline to Month 12
Change in MoCA Score From Baseline to Month 12
Tidsramme: Baseline to Month 12

The Montreal Cognitive Assessment (MoCA) total score ranges from 0 to 30, with higher scores indicating better cognitive performance and therefore a better cognitive outcome. Change in MoCA total score from baseline to Month 12 will be compared between the surgical intervention and control groups. A positive change from baseline indicates improvement, whereas a negative change indicates worsening.
Baseline to Month 12
Change in MMSE Score From Baseline to Month 12
Tidsramme: Baseline to Month 12

The Mini-Mental State Examination (MMSE) total score ranges from 0 to 30, with higher scores indicating better cognitive performance and therefore a better cognitive outcome. Change in MMSE total score from baseline to Month 12 will be compared between the surgical intervention and control groups. A positive change from baseline indicates improvement, whereas a negative change indicates worsening.
Baseline to Month 12
Procedure-Related Adverse Events and Serious Adverse Events
Tidsramme: From surgery through Month 12

Occurrence of adverse events and serious adverse events related to the surgical procedure during the study follow-up period.
From surgery through Month 12
Postoperative Complications
Tidsramme: From surgery through Month 12

Occurrence of postoperative complications following cervical lymphatic microsurgery, including local surgical complications assessed during follow-up.
From surgery through Month 12
Rehospitalization
Tidsramme: Up to Month 12

Occurrence of rehospitalization during the 12-month study follow-up period.
Up to Month 12
All-Cause Mortality
Tidsramme: Up to Month 12

Occurrence of death from any cause during the 12-month study follow-up period.
Up to Month 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Daniel Maliszewski

Samarbejdspartnere

University Clinical Centre, Gdansk
Janusz Korczak Provincial Specialist Hospital in Słupsk

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. maj 2029

Studieafslutning (Anslået)

1. maj 2029

Datoer for studieregistrering

Først indsendt

29. september 2026

Først indsendt, der opfyldte QC-kriterier

29. september 2026

Først opslået (Faktiske)

5. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AD-LVA-LNVA-2026-01

Plan for individuelle deltagerdata (IPD)

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