Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

Recruiting now · Not applicable

Conditions studied: Alzheimer Disease, Lymphatic Obstruction

In brief

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.

Key facts

Study ID: NCT07178210
Run by: MMI (Medical Microinstruments, Inc.)
People needed: 15
Starts: 2026-04-30
Expected to finish: 2027-10-30
Last updated by the study team: 2026-06-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient aged 50 or older
Patient has confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria
Patient has a positive amyloid PET test and/or a positive CSF t-tau/amyloid-beta-42 test
Patient has an MMSE score within the mild to moderate range (21-26 and 10-20)
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
Patient has confirmed extracranial lymphatic abnormalities in the head and neck region as identified by preoperative imaging
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 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…

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.
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.
History of head and neck radiation exposure
Patient with severe kidney disease (GFR <30 mL/min/1.73m2)
Patient with acute kidney injury
Active systemic infection under treatment with intravenous antibiotics
Patient has a modified Rankin Score (mRS) of >4
Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigator's discretion
Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
Patient with an active cancer diagnosis and/or currently receiving treatment for cancer or has received treatment within the past 6 months
Patient is currently receiving treatment or has been treated with anti-amyloid-beta monoclonal antibody therapy within the past 3 months
Patient has contraindication for MRI or intrathecal administration of gadobutrol
Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or study outcomes
Patient is ineligible to participate for other reasons in the judgment of the investigator

Where it is running

Stanford Medical Center — Palo Alto, California, United States (enrolling)
Baptist Health Research Institute — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.