Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease (REMIND)

MMI (Medical Microinstruments, Inc.)

Status

Not yet enrolling

Conditions

Lymphatic Obstruction

Alzheimer Disease

Treatments

Device: Symani Surgical System

Study type

Interventional

Funder types

Industry

Identifiers

NCT07178210

CDC-00157

Details and patient eligibility

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.

Full description

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.

Enrollment

15 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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