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Cervical Lymphatic Microsurgery in Alzheimer's Disease

5 oktober 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Procedur: 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.

Andra namn:
  • Lymph Node-to-Vein Anastomosis (LNVA)
  • Lymphaticovenous Anastomosis (LVA)
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Plasma Phosphorylated Tau 217 (p-tau217) Concentration From Baseline to Month 12
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in CDR-SB Score From Baseline to Month 12
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to Month 12

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

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Daniel Maliszewski

Samarbetspartners

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 maj 2029

Avslutad studie (Beräknad)

1 maj 2029

Studieregistreringsdatum

Först inskickad

29 september 2026

Först inskickad som uppfyllde QC-kriterierna

29 september 2026

Första postat (Faktisk)

5 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AD-LVA-LNVA-2026-01

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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Nej

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