Actively Recruiting
Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease
Led by MMI (Medical Microinstruments, Inc.) · Updated on 2026-04-15
15
Participants Needed
2
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 50 or older
- Confirmed mild to moderate Alzheimer's Disease according to National Institute of Aging-Alzheimer's Association criteria
- Positive amyloid PET test and/or positive cerebrospinal fluid t-tau/amyloid-beta-42 test
- MMSE score within mild to moderate range (10-26)
- CDR-SB score within mild to moderate range (4.5 to 15.5)
- Confirmed extracranial lymphatic abnormalities in head and neck region by imaging
- Investigator considers patient suitable for robotic-assisted microsurgical lymphatic surgery
- Patient or legally authorized representative provides informed consent and agrees to follow-up visits and study procedures
You will not qualify if you...
- Patient or legally authorized representative unwilling to provide informed consent
- Suspected dementia other than Alzheimer's (e.g., Lewy body, frontotemporal, vascular)
- Documented or suspected neurological or intracranial conditions affecting safety (e.g., stroke, tumors, seizures)
- History of head and neck radiation
- Severe kidney disease (GFR <30 mL/min/1.73m2)
- Acute kidney injury
- Active systemic infection treated with intravenous antibiotics
- Modified Rankin Score greater than 4
- Significant cardiovascular, digestive, respiratory, endocrine, central nervous system, or mental disorders affecting data or compliance
- History of significant bleeding disorders or Von Willebrand's disease
- Active cancer or cancer treatment within past 6 months
- Treatment with anti-amyloid-beta monoclonal antibody therapy within past 3 months
- Contraindication for MRI or intrathecal gadobutrol administration
- Enrollment in other investigational studies that may impact safety or outcomes
- Other investigator-determined reasons for ineligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Stanford Medical Center
Palo Alto, California, United States, 94305
Actively Recruiting
2
Baptist Health Research Institute
Jacksonville, Florida, United States, 32207
Actively Recruiting
Research Team
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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