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.
Patient aged 50 to < 80 years
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
Patient has an MMSE score≥ 18
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) is unwilling to provide informed consent
Patient has suspected dementia of other type, e.g., Lewy body, frontotemporal disorder, vascular, etc.
History of head and neck radiation exposure
Patient with severe kidney disease (GFR <30 mL/min/1.73m2)
Single group
Symani Surgical System
DeviceUse of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes.
Device-related serious adverse events at 30-days
All intraoperative and postoperative device-related serious adverse events (SAEs) will be captured from the start of the index procedure through 30 days post-index procedure for each participant. The device-related SAE rate will be reported at 30 days post-index procedure for all evaluable participants.
Rate of Serious Adverse Events (SAEs) through 12 months
All intraoperative and postoperative SAEs, regardless of device relatedness, will be captured from the start of the index procedure through 12 months post-index procedure for each participant. The freedom from SAE rate will be reported through 12 months post-index procedure for all evaluable participants.
Rate of Adverse Events (AEs) at 30 days
All intraoperative and postoperative AEs, regardless of seriousness or device relatedness, will be captured from the start of the index procedure through 30 days post-index procedure for each participant. The freedom from AE rate will be reported at 30 days post-index procedure for all evaluable participants.
Incidence of Post Operative Delirium
Post Operative Delirium occurrence shall be collected from the end of the indexing procedure through discharge, as an AE.
Change in Amyloid PET Centiloid Value at 6 and 12- Months
The centiloid (CL) value of an amyloid positron emission tomography (PET) imaging test will be performed at the patient's pre-procedure visit and at the 6 and 12-month follow-up visit for this comparison.
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