Cervical lymphatic surgery to see if it helps people with mild Alzheimer’s
Official title: Microsurgical Modification of Cervical Lymphatic Pathways in Alzheimer's Disease: A Pilot Study
Run by Maliszewski Daniel · NCT07857759 · Data updated 2026-11-12
We’re testing a surgical approach in people with mild Alzheimer’s to see if creating alternative neck lymph drainage routes can affect brain biomarkers and daily function.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Maliszewski Daniel Academic / other |
| Locations | 2 sites (Gdansk and 1 other locations) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | May 2029 |
| Study ends | May 2029 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT07857759 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with mild Alzheimer’s disease (CDR 0.5–1.0; MMSE 20–26) and confirmed AD pathology, who are medically fit for surgery and can consent.
✕Probably not a fit
Patients with more advanced disease, other neurodegenerative conditions, or neck surgical/radiation history that affects drainage may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this pilot study, participants with mild Alzheimer’s will be randomly assigned to either a neck microsurgical procedure to connect lymphatic pathways or to standard observation for 12 months. The intervention may use manual techniques or robotic assistance to perform lymphaticovenous or lymph node-to-vein anastomoses in the neck. The trial’s main goal is to see if plasma p-tau217 changes over 12 months, with secondary checks on cognitive and functional measures such as the CDR-SB. Eligible participants have mild disease, stable treatment, and confirmed AD pathology via biomarkers.
Why it matters
Potential benefit: If successful, this approach could offer a new treatment pathway that may modify disease biology and slow progression.
How similar studies have gone: Similar lymphatic drainage approaches are being explored; this exact intervention is novel in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Poland Recruiting -
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
Słupsk, Poland Recruiting
Study contacts
- Study coordinator: Daniel Maliszewski, MD, PhD
- Email: danielmal2@gmail.com
- Phone: +48 501784896
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.