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Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease | Clinical Trials | Clareo Health

RECRUITINGNA

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A Global, Prospective, Early Feasibility Study in Alzheimer's Patients

NCT07178210•MMI (Medical Microinstruments, Inc.)

View on ClinicalTrials.gov

Summary

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.

Detailed 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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
•9. 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
•10. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
+5 more criteria

Locations (1)

Baptist Health Research Institute

Jacksonville, Florida, United States

Key Dates

Start Date

March 31, 2026

Primary Completion Date

August 31, 2026

Completion Date

August 31, 2027

Last Updated

March 16, 2026

Enrollment

ESTIMATED participants

Conditions

Alzheimer DiseaseLymphatic Obstruction

Interventions

Symani Surgical System

DEVICE

Contacts

Clinical Operations

CONTACT

8336646276 clinical.ops@mmimicro.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

Inclusion Criteria

Exclusion Criteria

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