Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - EU

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Device-related serious adverse events at 30-days [Срок оценки: The duration of the participants' index procedure through 30-days post index procedure.]

Вторичные конечные точки (11)

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

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07708675 · CDC-00176

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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