Cervical Lymphatic Microsurgery in Alzheimer's Disease
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Daniel Maliszewski, MD, PhD
- Telefonní číslo: +48 501784896
- E-mail: danielmal2@gmail.com
Studijní záloha kontaktů
- Jméno: Kamil Chwojnicki, MD, PhD
- Telefonní číslo: +48 506135515
- E-mail: kchwoj@gumed.edu.pl
Studijní místa
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Gdansk, Polsko, 80-952
- Nábor
- Uniwersyteckie Centrum Kliniczne w Gdańsku
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Kontakt:
- Kamil Chwojnicki, MD, PhD
- Telefonní číslo: +48 506 135 515
- E-mail: kchwoj@gumed.edu.pl
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Vrchní vyšetřovatel:
- Kamil Chwojnicki, MD, PhD
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Słupsk, Polsko, 76-200
- Nábor
- Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
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Kontakt:
- Daniel Maliszewski, MD, PhD
- Telefonní číslo: +48 501 784 896
- E-mail: danielmal2@gmail.com
-
Vrchní vyšetřovatel:
- Daniel Maliszewski, MD, PhD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
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.
Ostatní jména:
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Žádný zásah: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Plasma Phosphorylated Tau 217 (p-tau217) Concentration From Baseline to Month 12
Časové okno: Baseline to Month 12
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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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in CDR-SB Score From Baseline to Month 12
Časové okno: Baseline to Month 12
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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
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Change in ADCS-ADL Score From Baseline to Month 12
Časové okno: 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
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Change in MoCA Score From Baseline to Month 12
Časové okno: Baseline to Month 12
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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
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Change in MMSE Score From Baseline to Month 12
Časové okno: 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
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Procedure-Related Adverse Events and Serious Adverse Events
Časové okno: From surgery through Month 12
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Occurrence of adverse events and serious adverse events related to the surgical procedure during the study follow-up period. |
From surgery through Month 12
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Postoperative Complications
Časové okno: From surgery through Month 12
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Occurrence of postoperative complications following cervical lymphatic microsurgery, including local surgical complications assessed during follow-up. |
From surgery through Month 12
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Rehospitalization
Časové okno: Up to Month 12
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Occurrence of rehospitalization during the 12-month study follow-up period. |
Up to Month 12
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All-Cause Mortality
Časové okno: Up to Month 12
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Occurrence of death from any cause during the 12-month study follow-up period. |
Up to Month 12
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AD-LVA-LNVA-2026-01
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