About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Symani Surgical System