Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A Global, Prospective, Early Feasibility Study in Alzheimer's Patients

The objective of this investigational device exemption (IDE) study is to evaluate the safety and feasibility of using the Symani System and microsurgical techniques in the deep cervical lymph node (dCLN) region in the setting of mild to moderate Alzheimer's disease and lymphatic abnormalities.

A prospective, multi-center, early feasibility study, designed to evaluate the Symani System's safety and feasibility for performing microsurgical techniques in the dCLN region to improve clearance of neurotoxins, such as amyloid-beta and phosphorylated tau, in patients with confirmed mild to moderate Alzheimer's disease and lymphatic abnormalities in the dCLN region.

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