Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - EU

NCT07708675 | Not Yet Recruiting DMC

• 1 other identifier: CDC-00176
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alzheimer's

Keywords

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Rate of Serious Adverse Events (SAEs) through 12 months

  The duration of the participants' index procedure through 12-months post index procedure.

• Rate of Adverse Events (AEs) at 30 days

  The duration of the participants' index procedure through 30-days post index procedure.

• Incidence of Post Operative Delirium

  From Day 0 visit through 12-24 hours prior to discharge.

• Change in Amyloid PET Centiloid Value at 6 and 12- Months

  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

  The duration of the participants' pre-procedure visit through 3, 6, and 12-months post index procedure.

Study Arms (1)

Alzheimer's Disease

EXPERIMENTAL

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

Interventions

Symani Surgical System DEVICE

Use of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes.

Alzheimer's Disease

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 50 to \< 80 years
• 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
• Patient has an MMSE score≥ 18
• 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)
• Patients who are of childbearing potential must agree to use a medically acceptable form of contraception.
• 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 imaging confirms lymphatic nodes/vessels amenable to reconstruction

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.
• 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
• 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
• 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 6 months
• Patient has contraindication for MRI
• 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
• \. 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

Sponsors & Collaborators

• MMI (Medical Microinstruments, Inc.): lead

MeSH Terms

Conditions

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Alzheimer Disease

Central Study Contacts

Clinical Operations

CONTACT

8336646276; clinical.ops@mmimicro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07