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Not yet recruiting NCT07708675

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - EU

No phase Interventional Alzheimer's

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Symani Surgical System.
Who it may be relevant to
Registry conditions: Alzheimer's. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Device-related serious adverse events at 30-days [Time frame: The duration of the participants' index procedure through 30-days post index procedure.]
Secondary outcome measures (11)
  • Rate of Serious Adverse Events (SAEs) through 12 months [Time frame: The duration of the participants' index procedure through 12-months post index procedure.]
  • Rate of Adverse Events (AEs) at 30 days [Time frame: The duration of the participants' index procedure through 30-days post index procedure.]
  • Incidence of Post Operative Delirium [Time frame: From Day 0 visit through 12-24 hours prior to discharge.]
  • Change in Amyloid PET Centiloid Value at 6 and 12- Months [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.]

Eligibility criteria

Preoperative Inclusion Criteria:

  • 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 Inclusion Criteria:

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

Preoperative 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.
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07708675 · CDC-00176

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗