Robot scalpels take on Alzheimer's: could clearing neck lymph nodes slow the disease?

NCT ID NCT07708675

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests whether a robotic surgical system can safely perform delicate microsurgery on deep lymph nodes in the neck of people with Alzheimer's disease. The idea is that improving lymph drainage from the brain might help clear harmful proteins linked to Alzheimer's. The trial will enroll 50 participants and primarily look at safety and feasibility over 30 days and up to 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Symani Surgical System for microsurgery on deep cervical lymph nodes
What this could lead to
If safe and effective, this approach could open a new surgical avenue for potentially slowing Alzheimer's progression by improving brain waste clearance.
What could go wrong
This is an early feasibility study with only 50 participants, focused on safety, not yet on whether it helps Alzheimer's symptoms. The surgery itself carries risks like infection or nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Preoperative Inclusion Criteria: 1. Patient aged 50 to \< 80 years 2. Patient has confirmed highly probable or probable Alzheimer's disease according to the International Working Group (IWG) Patient and has a positive core 1 Alzheimer biomarker according to the Alzheimer's Association (AA) criteria 3. Patient has an MMSE score≥ 18 4. Investigator deems the candidate acceptable for lymphatic surgery with a robotic-assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU) 5. Patients who are of childbearing potential must agree to use a medically acceptable form of contraception. 6. Patient or their legally authorized representative agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure Intraoperative Inclusion Criteria: 1\. Intraoperative imaging confirms lymphatic nodes/vessels amenable to reconstruction Preoperative Exclusion Criteria: 1. Patient (or their legally authorized representative) is unwilling to provide informed consent 2. Patient has suspected dementia of other type, e.g., Lewy body, frontotemporal disorder, vascular, etc. 3. History of head and neck radiation exposure 4. Patient with severe kidney disease (GFR \<30 mL/min/1.73m2) 5. Patient with acute kidney injury 6. Active systemic infection under treatment with intravenous antibiotics 7. Patient has a modified Rankin Score (mRS) of \>4 8. Documented history of clinically significant diagnosis of cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, untreated sleep apnea, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigator's discretion 9. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease 10. Patient with an active cancer diagnosis and/or currently receiving treatment for cancer or has received treatment within the past 6 months 11. Patient is currently receiving treatment or has been treated with anti-amyloid-beta monoclonal antibody therapy within the past 6 months 12. Patient has contraindication for MRI 13. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or study outcomes 14. Patient is ineligible to participate for other reasons in the judgment of the investigator Intraoperative Exclusion Criteria: 1\. Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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