Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

Korábbi kezelés

• Active systemic infection under treatment with intravenous antibiotics
• 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
• Patient with an active cancer diagnosis and/or currently receiving treatment for cancer or has received treatment within the past 6 months
• Patient is currently receiving treatment or has been treated with anti-amyloid-beta monoclonal antibody therapy within the past 3 months

Más betegség

• Patient has suspected dementia of other type, e.g., Lewy body, frontotemporal disorder, vascular, etc.
• 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.
• History of head and neck radiation exposure
• Known history of significant bleeding, coagulopathy, or Von Willebrand's disease

Laborértékek

• Patient with severe kidney disease (GFR <30 mL/min/1.73m2)

Egyéb

• Patient (or their legally authorized representative) is unwilling to provide informed consent
• Patient with acute kidney injury
• Patient has a modified Rankin Score (mRS) of >4
• Patient has contraindication for MRI or intrathecal administration of gadobutrol
• Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or study outcomes
• Patient is ineligible to participate for other reasons in the judgment of the investigator

• 50 to 80 years of age
• Patients who are of childbearing potential must agree to use a medically acceptable form of contraception for the duration of the study
• Patient has confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria
• Patient has a positive amyloid PET test and/or a positive CSF t-tau/amyloid-beta-42 test
• Patient has an MMSE score within the mild to moderate range (21-26 and 10-20)
• 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
• Patient has confirmed extracranial lymphatic abnormalities in the head and neck region as identified by preoperative imaging
• 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)
• 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