NCT07857759Recruiting
Cervical Lymphatic Microsurgery in Alzheimer's Disease
Microsurgical Modification of Cervical Lymphatic Pathways in Alzheimer's Disease: A Pilot Study
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 29 Sept 2026
- Start date
- Sept 2026
- Primary completion date
- May 2029
- Lead sponsor
- Daniel Maliszewski
- Diseases
- Alzheimer disease
- NCT number
- NCT07857759
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Sept 2026 to the primary completion date, May 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous major neck surgery or radiotherapy to the neck that may affect lymphatic drainage.
Other illness
- Moderate or severe Alzheimer's disease.
- Other neurodegenerative disorders or significant psychiatric disorders.
- Active infection or coagulation disorders.
Other
- Contraindications to general anesthesia.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uniwersyteckie Centrum Kliniczne w Gdańsku Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o. Coordinator of this site? Confirm its status | Słupsk | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.