Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - EU

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A European, Prospective, Multi-Center, Open Label Study in Alzheimer's Patients

The objective of this study is to evaluate the safety and feasibility of the Symani System and microsurgical techniques in the deep Cervical Lymph Node (dCLN) region in patients with confirmed Alzheimer's disease.

A prospective, multicenter open label study, designed to evaluate the Symani System's safety and feasibility for performing microsurgical techniques in the dCLNs to improve clearance of neurotoxins, such as amyloid-beta and phosphorylated tau, in patients with confirmed highly probable or probable Alzheimer's Disease, according to the International Working Group (IWG) and a positive core 1 Alzheimer biomarker according to the Alzheimer's Association (AA) 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