Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - EU (REMIND-EU)

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A European, Prospective, Multi-Center, Open Label Study in Alzheimer's Patients

The objective of this study is to evaluate the safety and feasibility of the Symani System and microsurgical techniques in the deep Cervical Lymph Node (dCLN) region in patients with confirmed Alzheimer's disease.

Study Overview

• Status: Not yet recruiting
• Conditions: Alzheimer's
• Intervention / Treatment: Device: Symani Surgical System

Detailed Description

A prospective, multicenter open label study, designed to evaluate the Symani System's safety and feasibility for performing microsurgical techniques in the dCLNs to improve clearance of neurotoxins, such as amyloid-beta and phosphorylated tau, in patients with confirmed highly probable or probable Alzheimer's Disease, according to the International Working Group (IWG) and a positive core 1 Alzheimer biomarker according to the Alzheimer's Association (AA) criteria.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Operations; Phone Number: 5 8336646276; Email: clinical.ops@mmimicro.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Preoperative Inclusion Criteria:

1. Patient aged 50 to < 80 years
2. Patient has confirmed highly probable or probable Alzheimer's disease according to the International Working Group (IWG) Patient and has a positive core 1 Alzheimer biomarker according to the Alzheimer's Association (AA) criteria
3. Patient has an MMSE score≥ 18
4. 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)
5. Patients who are of childbearing potential must agree to use a medically acceptable form of contraception.
6. 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

Intraoperative Inclusion Criteria:

1. Intraoperative imaging confirms lymphatic nodes/vessels amenable to reconstruction

Preoperative 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. History of head and neck radiation exposure
4. Patient with severe kidney disease (GFR <30 mL/min/1.73m2)
5. Patient with acute kidney injury
6. Active systemic infection under treatment with intravenous antibiotics
7. Patient has a modified Rankin Score (mRS) of >4
8. Documented history of clinically significant diagnosis of cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, untreated sleep apnea, 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
9. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
10. Patient with an active cancer diagnosis and/or currently receiving treatment for cancer or has received treatment within the past 6 months
11. Patient is currently receiving treatment or has been treated with anti-amyloid-beta monoclonal antibody therapy within the past 6 months
12. Patient has contraindication for MRI
13. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or study outcomes
14. Patient is ineligible to participate for other reasons in the judgment of the investigator

Intraoperative Exclusion Criteria:

1. Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alzheimer's Disease; Patient with confirmed mild to moderate Alzheimer's Disease according to the International Working Group (IWG) and a positive core 1 Alzheimer biomarker according to the Alzheimer's Association (AA) criteria.	Device: Symani Surgical System; Use of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related serious adverse events at 30-days	All intraoperative and postoperative device-related serious adverse events (SAEs) will be captured from the start of the index procedure through 30 days post-index procedure for each participant. The device-related SAE rate will be reported at 30 days post-index procedure for all evaluable participants.	The duration of the participants' index procedure through 30-days post index procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Serious Adverse Events (SAEs) through 12 months	All intraoperative and postoperative SAEs, regardless of device relatedness, will be captured from the start of the index procedure through 12 months post-index procedure for each participant. The freedom from SAE rate will be reported through 12 months post-index procedure for all evaluable participants.	The duration of the participants' index procedure through 12-months post index procedure.
Rate of Adverse Events (AEs) at 30 days	All intraoperative and postoperative AEs, regardless of seriousness or device relatedness, will be captured from the start of the index procedure through 30 days post-index procedure for each participant. The freedom from AE rate will be reported at 30 days post-index procedure for all evaluable participants.	The duration of the participants' index procedure through 30-days post index procedure.
Incidence of Post Operative Delirium	Post Operative Delirium occurrence shall be collected from the end of the indexing procedure through discharge, as an AE.	From Day 0 visit through 12-24 hours prior to discharge.
Change in Amyloid PET Centiloid Value at 6 and 12- Months	The centiloid (CL) value of an amyloid positron emission tomography (PET) imaging test will be performed at the patient's pre-procedure visit and at the 6 and 12-month follow-up visit for this comparison.	The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
Change in Plasma Biomarkers at 3, 6, and 12 Months: amyloidβ-42 and 40, amyloidβ-42/40 ratio, ptau-217, NfL and GFAP	Blood panel testing for amyloidβ-42 and 40, amyloidβ-42/40 ratio, ptau-217, neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) will be taken at the patient's pre-procedure visit and at the 3, 6, and 12-month follow-up visits.	The duration of the participants' pre-procedure visit through 3, 6, and 12-months post index procedure.
Change in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score at 6 and 12 Months	CDR-SB will be evaluated at the patient's pre-procedure visit and at the 6 and 12-month follow-up visit. The CDR-SB scores can take a value between 0 and 18.	The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Domains at 6 and 12 Months	Each of the 6 domains of the CDR-SB -- memory, orientation, judgement, problem solving, community affairs, home and hobbies, and personal care -- will be evaluated at the patient's pre-procedure visit and at the 6 and 12-month follow-up visit.	The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
Alzheimer's Disease Assessment Scvale-Cognitive (ADAS-Cog14) at 6 and 12 months	ADAS-Cog14 will be evaluated at the patient's pre-procedure visit and at the 6 and 12-month follow-up visit. The scores range from 0 to 70.	The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
Mini-Mental State Examination (MMSE) at 6 and 12 Months	MMSE will be evaluated at the patient's pre-procedure visit and at the 6 and 12-month follow-up visit. The scores range from 0 to 30.	The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
Activities of Daily Living (ADSC-ADL) at 6 and 12-Months	ADSC-ADL will be evaluated at the patient's pre-procedure visit and at the 6-month follow-up visit. The scores range from 0 to 78. Questions are asked of the patient's caregiver/family member to best gauge the patient's ability to complete basic and instrumental activities of daily living	The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
Change in Zarit Burden Interview (ZBI) at 6 and 12 months	The ZBI shall be administered at the patient's pre-procedural visit and at the 6 and 12-month visits. This 22-item scale is administered to the patient's caregiver/family member to assess the caregiver's burden.	The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.

Collaborators and Investigators

• Sponsor: MMI (Medical Microinstruments, Inc.)

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Nervous System Diseases; Dementia; Alzheimer Disease; Central Nervous System Diseases; Neurodegenerative Diseases; Mental Disorders; Brain Diseases; Neurocognitive Disorders; Tauopathies
• Additional Relevant MeSH Terms: Alzheimer Disease; Mental Disorders; Dementia; Brain Diseases; Nervous System Diseases; Neurodegenerative Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Tauopathies
• Other Study ID Numbers: CDC-00176

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No