NCT07708675尚未招募不适用
Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A European, Prospective, Multi-Center, Open Label Study in Alzheimer's Patients
MMI (Medical Microinstruments, Inc.)0 个研究点目标入组 50 人开始时间: 2026年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Device-related serious adverse events at 30-days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Device-related serious adverse events at 30-days
时间窗: The duration of the participants' index procedure through 30-days post index procedure.
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.
次要结局
- 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.)
- Change in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score at 6 and 12 Months(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(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(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(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(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 duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.)
研究者
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