MMI (Medical Microinstruments, Inc.)
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…
Use of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes.
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