Alzheimer DiseaseNCT07857759
Cervical Lymphatic Microsurgery in Alzheimer's Disease
A study testing Cervical Lymphatic Microsurgery in people with Alzheimer Disease, run by Daniel Maliszewski at 2 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Cervical Lymphatic Microsurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPoland
- Study dates
- Sep 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, 80-952
Kamil Chwojnicki, MD, PhD, +48 506 135 515, kchwoj@gumed.edu.pl
Kamil Chwojnicki, MD, PhD
- Recruiting
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
Słupsk, 76-200
Daniel Maliszewski, MD, PhD, +48 501 784 896, danielmal2@gmail.com
Daniel Maliszewski, MD, PhD
About this study
Official title: 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.
Read more
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.
- Conditions
- Alzheimer Disease
- Being tested
- Cervical Lymphatic Microsurgery
- Keywords
- Mild Alzheimer Disease, Cervical Lymphatic Drainage, Lymphovenous Anastomosis, Lymph Node-to-Vein Anastomosis, Supermicrosurgery, Phosphorylated Tau 217
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Lymphatic MicrosurgeryProcedure or surgery
Also called Lymph Node-to-Vein Anastomosis (LNVA), Lymphaticovenous Anastomosis (LVA)
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Intervention | Experimental | 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. Receives: Procedure: Cervical Lymphatic Microsurgery |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Phosphorylated Tau 217 (p-tau217) Concentration From 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.
Measured: Baseline to Month 12
Secondary outcomes (8)
Change in CDR-SB Score From 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.
Measured: Baseline to Month 12
Change in ADCS-ADL Score From 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.
Measured: Baseline to Month 12
Change in MoCA Score From 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.
Measured: Baseline to Month 12
Change in MMSE Score From 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.
Measured: Baseline to Month 12
Procedure-Related Adverse Events and Serious Adverse Events
Occurrence of adverse events and serious adverse events related to the surgical procedure during the study follow-up period.
Measured: From surgery through Month 12
Postoperative Complications
Occurrence of postoperative complications following cervical lymphatic microsurgery, including local surgical complications assessed during follow-up.
Measured: From surgery through Month 12
Rehospitalization
Occurrence of rehospitalization during the 12-month study follow-up period.
Measured: Up to Month 12
All-Cause Mortality
Occurrence of death from any cause during the 12-month study follow-up period.
Measured: Up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-group pilot study with 1:1 block randomization to surgical intervention or clinical observation without surgery during the first 12 months. After completion of the 12-month observation period, control participants may elect to undergo the surgical procedure.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Maliszewski
- Sponsor type
- University, hospital or other
- Collaborators
- Janusz Korczak Provincial Specialist Hospital in Słupsk, University Clinical Centre, Gdansk
- Responsible party
- Sponsor-investigator, Daniel Maliszewski, Maliszewski Daniel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857759
- Sponsor's protocol ID
- AD-LVA-LNVA-2026-01
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microsurgical Modification of Cervical Lymphatic Pathways in Alzheimer's Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT07857759
- Acronym / sponsor ID
- AD-LVA-LNVA-2026-01
- Conditions
- Alzheimer Disease
- Keywords
- Mild Alzheimer Disease, Cervical Lymphatic Drainage, Lymphovenous Anastomosis, Lymph Node-to-Vein Anastomosis, Supermicrosurgery, Phosphorylated Tau 217
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Daniel MaliszewskiUniversity, hospital or other
- Collaborators
- Janusz Korczak Provincial Specialist Hospital in Słupsk, University Clinical Centre, Gdansk
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel-group pilot study with 1:1 block randomization to surgical intervention or clinical observation without surgery during the first 12 months. After completion of the 12-month observation period, control participants may elect to undergo the surgical procedure.
| Arm | Type | Receives |
|---|---|---|
| Surgical Intervention | Experimental | Procedure: Cervical Lymphatic MicrosurgeryParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Lymphatic MicrosurgeryAlso: Lymph Node-to-Vein Anastomosis (LNVA), Lymphaticovenous Anastomosis (LVA)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. | Procedure or surgery | Surgical Intervention |
Primary outcome
Change in Plasma Phosphorylated Tau 217 (p-tau217) Concentration From Baseline to Month 12
Time frame: 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.
8 secondary outcomes
Change in CDR-SB Score From Baseline to Month 12
Time frame: Baseline to Month 12
Change in ADCS-ADL Score From Baseline to Month 12
Time frame: Baseline to Month 12
Change in MoCA Score From Baseline to Month 12
Time frame: Baseline to Month 12
Change in MMSE Score From Baseline to Month 12
Time frame: Baseline to Month 12
Procedure-Related Adverse Events and Serious Adverse Events
Time frame: From surgery through Month 12
Postoperative Complications
Time frame: From surgery through Month 12
Rehospitalization
Time frame: Up to Month 12
All-Cause Mortality
Time frame: Up to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Lymphatic Microsurgery in people with Alzheimer Disease, run by Daniel Maliszewski at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Maliszewski, MD, PhD (+48 501784896, danielmal2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Phosphorylated Tau 217 (p-tau217) Concentration From Baseline to Month 12 (time frame: Baseline to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.