NCT07708675 · NOT YET RECRUITING
Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - EU
This trial is testing a robotic surgical system called Symani to perform microsurgery on lymph nodes in the neck of people who already have confirmed Alzheimer's disease. The idea is that improving lymphatic drainage in that region may help clear waste from the brain. This is a feasibility and safety study — Phase NA means researchers are evaluating whether the procedure can be done safely, not whether it works to change the disease.
Eligibility criteria
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-07-16