RecruitingAlzheimer DiseaseLymphatic Obstruction
Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease
Eligible age
50+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: MMI (Medical Microinstruments, Inc.)
You may qualify if…
- ✓ 1. Patient aged 50 or older
- ✓ 2. Patient has confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria
- ✓ 3. Patient has a positive amyloid PET test and/or a positive CSF t-tau/amyloid-beta-42 test
- ✓ 4. Patient has an MMSE score within the mild to moderate range (21-26 and 10-20)
- ✓ 5. 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
- ✓ 6. Patient has confirmed extracranial lymphatic abnormalities in the head and neck region as identified by preoperative imaging
- ✓ 7. 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)
- ✓ 8. 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
You may not qualify if…
- ✕ 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
Where it's recruiting
California
Palo Alto
Florida
Jacksonville
Source: ClinicalTrials.gov · NCT07178210 · last updated 2026-06-02