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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sinaptica Therapeutics, Inc., a clinical-stage company leading the development of a new class of personalized neuromodulation therapeutics to treat Alzheimer’s and other primary neurodegenerative diseases, today announced that the company will present an oral presentation with results of a 52-week Phase 2 study in Mild-to-Moderate Alzheimer’s disease at the Clinical Trials on Alzheimer’s Disease (CTAD) conference being held October 29-November 1, 2024, in Madrid..
马萨诸塞州剑桥市(商业新闻短讯)--临床阶段公司Sinaptica Therapeutics,Inc.今天宣布,该公司将在2024年10月29日至11月1日于马德里举行的阿尔茨海默氏病临床试验(CTAD)会议上口头介绍一项为期52周的轻度至中度阿尔茨海默氏病2期研究结果,该公司领导开发一类新的个性化神经调节疗法,用于治疗阿尔茨海默氏病和其他原发性神经退行性疾病。。
Details of the oral presentation are as follows:
口头陈述的细节如下:
Title: Results of a 52-Week Phase II Trial of Repetitive TMS of the Default Mode Network in Mild to Moderate Alzheimer’s Disease
标题:轻度至中度阿尔茨海默病默认模式网络重复TMS的52周II期试验结果
Session Name: ORAL COMMUNICATIONS: Emerging Solutions: Novel Approaches to Treating Alzheimer’s Disease
课程名称:口头交流:新兴解决方案:治疗阿尔茨海默病的新方法
Session Date and Time: Thursday, October 31 from 11:25 a.m. to 12:00 p.m. CET
会议日期和时间:10月31日星期四上午11:25至下午12:00,欧洲中部时间
Location: Auditorium, Madrid Marriott Auditorium Hotel and Conference Center
地点:马德里万豪礼堂酒店和会议中心礼堂
Additional data will also be presented in a late-breaker poster by Pentara and colleagues titled “Additional Analysis of a 52-Week Phase II Trial of Neuromodulation of the Default Mode Network to Optimize Design of a Phase 3 Trial to Demonstrate Clinical Meaningfulness.”
Pentara及其同事还将在一份名为“对默认模式网络神经调节的52周II期试验进行额外分析,以优化3期试验的设计,以证明临床意义”的后期海报中提供更多数据
About the SinaptiStim® System
关于SinaptiStim®系统
The SinaptiStim® System is an investigational new approach to treating Alzheimer’s disease using non-invasive personalized precision neuromodulation. Calibrated to each individual’s brain, the therapy is delivered weekly in 20-minute sessions in a recliner, with safe, painless, customized neurostimulation technology targeting prescribed areas of the precuneus section of the brain.
SinaptiStim®系统是一种使用非侵入性个性化精确神经调节治疗阿尔茨海默病的研究性新方法。该疗法针对每个人的大脑进行校准,每周在躺椅上进行20分钟的治疗,安全,无痛,定制的神经刺激技术针对大脑楔前叶的指定区域。
The precuneus is the central hub of the Default Mode Network (DMN), an important brain network associated with episodic memory and introspection. There has been a tremendous amount of recent research identifying the DMN as playing a central role in AD pathology and progression. It is thought that stimulating the DMN increases neuroplasticity and stabilizes the brain’s electrical network, helping to preserve existing connectivity and build new memory pathways and connections..
楔前叶是默认模式网络(DMN)的中心枢纽,DMN是与情景记忆和内省相关的重要大脑网络。最近有大量研究确定DMN在AD病理学和进展中起着核心作用。据认为,刺激DMN可以增加神经可塑性,稳定大脑的电网络,有助于保持现有的连通性,建立新的记忆通路和连接。。
The technology was granted Breakthrough Device Designation by the FDA in 2022 and the company is preparing for a pivotal randomized controlled clinical trial in 2025. In the upcoming trial the treatment will be calibrated quarterly using TMS and EEG concurrently in combination with MRI-guided neuronavigation, which enables the SinaptiStim System to achieve customized precise repeatable targeting and dosage for each patient, tracking progress and adjusting over time to achieve the best possible individualized outcomes with its nDMN therapy.
该技术于2022年获得美国食品和药物管理局(FDA)的突破性设备指定,该公司正准备在2025年进行一项关键的随机对照临床试验。在即将到来的试验中,治疗将每季度使用TMS和EEG同时结合MRI引导的神经导航进行校准,这使得SinaptiStim系统能够为每位患者实现定制的精确可重复靶向和剂量,跟踪进展并随着时间的推移进行调整,以实现其nDMN治疗的最佳个性化结果。
The pivotal trial will also be designed to determine the effects of SinaptiStim® System on several biomarkers measuring beta amyloid, phosphorylated tau, neural inflammation, and synaptic transmission..
该关键试验还将被设计用于确定SinaptiStim®系统对几种测量β淀粉样蛋白,磷酸化tau,神经炎症和突触传递的生物标志物的影响。。
About Sinaptica Therapeutics
Sinaptica Therapeutics is a clinical-stage neuromodulation therapeutics company leading the development of a new class of novel personalized therapeutics to revolutionize the treatment of Alzheimer’s and other primary neurodegenerative diseases. The company utilizes a patented non-invasive approach to treating Alzheimer's via precision neurostimulation of a key brain network involved in memory, the Default Mode Network.
Sinaptica Therapeutics是一家临床阶段神经调节治疗公司,领导开发一类新型个性化治疗药物,彻底改变阿尔茨海默病和其他原发性神经退行性疾病的治疗方法。该公司利用一种获得专利的非侵入性方法,通过对涉及记忆的关键大脑网络(默认模式网络)的精确神经刺激来治疗阿尔茨海默氏病。
Sinaptica’s scientific co-founders pioneered research on this novel approach which a growing body of evidence indicates can slow disease progression. Sinaptica’s mission is to bring a safe, effective, and non-invasive neuromodulation therapy to Alzheimer’s patients that can help to significantly slow the progression of cognitive, functional, and behavioral decline.
Sinaptica的科学联合创始人开创了这种新方法的研究,越来越多的证据表明这种方法可以减缓疾病的进展。Sinaptica的使命是为阿尔茨海默氏病患者带来一种安全、有效、无创的神经调节疗法,这有助于显着减缓认知、功能和行为衰退的进展。
Learn more at sinapticatx.com and follow us on LinkedIn and X @SinapticaTX..
请访问sinapticatx.com了解更多信息,并在LinkedIn和X@sinapticatx上关注我们。。
The SinaptiStim® System is for investigational use only. It has not been approved by the U.S. Food and Drug Administration and is not available for commercial sale in any geography.
SinaptiStim®系统仅供研究使用。它尚未获得美国食品和药物管理局的批准,也不可在任何地区进行商业销售。