Robot scalpel takes on Alzheimer's: tiny neck surgery aims to clear brain waste
NCT ID NCT07178210
First seen Jun 25, 2026 · Last updated Aug 25, 2026 · Updated 4 times
Summary
This early study tests whether a robot can safely perform microsurgery on deep neck lymph nodes in 15 people with mild-to-moderate Alzheimer's. The idea is that clearing blockages in these lymph nodes might help the brain remove harmful waste. The main goal is to check safety, not yet to see if it improves memory or thinking.
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 (robot-assisted microsurgery device)
- What this could lead to
- If successful, this could point toward a new way to treat Alzheimer's by improving brain waste clearance through neck lymph node surgery.
- What could go wrong
- This is a very early, small feasibility study (15 people) focused on safety, not effectiveness. The surgery itself carries risks like infection or nerve damage, and it's unknown if it will help Alzheimer's symptoms.
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
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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
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Inclusion Criteria: 1. 50 to 80 years of age 2. Patients who are of childbearing potential must agree to use a medically acceptable form of contraception for the duration of the study 3. Patient has confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria 4. Patient has a positive amyloid PET test and/or a positive CSF t-tau/amyloid-beta-42 test 5. Patient has an MMSE score within the mild to moderate range (21-26 and 10-20) 6. Patient has CDR-SB score within the mild to moderate range; mild is 4.5to 9.0 and moderate is 9.5 to 15.5 7. Patient has confirmed extracranial lymphatic abnormalities in the head and neck region as identified by preoperative imaging 8. 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) 9. 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 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. Patient has documented or suspected neurological or intracranial conditions such as cerebrovascular accident, tumors, intracranial space occupying lesions, seizures or other intracranial/neurological conditions that may affect their safety in the study. 4. History of head and neck radiation exposure 5. Patient with severe kidney disease (GFR \<30 mL/min/1.73m2) 6. Patient with acute kidney injury 7. Active systemic infection under treatment with intravenous antibiotics 8. Patient has a modified Rankin Score (mRS) of \>4 9. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, untreated sleep apnea, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigator's discretion 10. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease 11. Patient with an active cancer diagnosis and/or currently receiving treatment for cancer or has received treatment within the past 6 months 12. Patient is currently receiving treatment or has been treated with anti-amyloid-beta monoclonal antibody therapy within the past 3 months 13. Patient has contraindication for MRI or intrathecal administration of gadobutrol 14. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or study outcomes 15. Patient is ineligible to participate for other reasons in the judgment of the investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baptist Health Research Institute
RECRUITINGJacksonville, Florida, 32207, United States
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Stanford Medical Center
RECRUITINGPalo Alto, California, 94305, United States
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The Research Foundation for State University of New York
RECRUITINGBuffalo, New York, 14203, United States
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- Can a home device slow Alzheimer's? pilot study tests pulsed electromagnetic therapy