Cognito的Spectris AD在试验中减缓了阿尔茨海默病的进展-动脉网

Cognito’s Spectris AD slows Alzheimer’s disease progression in trial

Medical Device Network 等信源发布 2025-06-12 12:59

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Spectris AD has been granted breakthrough device designation by the FDA. Credit: Cognito Therapeutics / Business Wire.

Spectris AD 已被 FDA 授予突破性设备称号。图片来源：Cognito Therapeutics / Business Wire。

Cognito Therapeutics has reported outcomes from a post hoc analysis of its OVERTURE feasibility trial, indicating that the investigational Spectris AD therapy can slow the progression of Alzheimer’s disease.

Cognito Therapeutics 报告了其 OVERTURE 可行性试验的事后分析结果，表明研究中的 Spectris AD 疗法可以减缓阿尔茨海默病的进展。

The device utilises non-invasive neuromodulation with synchronised light and sound at a gamma frequency to restore disrupted brain activity in Alzheimer’s patients.

该设备利用伽马频率同步的光和声音进行非侵入性神经调节，以恢复阿尔茨海默病患者中断的大脑活动。

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The study involved 76 mild-to-moderate affected subjects. It included a randomised six-month controlled phase and a subsequent 12-month open-label extension.

该研究涉及76名轻度至中度受影响的受试者，包括一个为期六个月的随机对照阶段和随后的12个月开放标签延长期。

During the controlled phase, one-hour treatments with the device daily led to 4.83 months of preserved daily activity, 4.56 and 4.09 months of delayed cognitive decline and whole-brain atrophy, respectively.

在对照阶段，每天使用该设备进行一小时的治疗，可以保持日常活动能力达4.83个月，分别延缓认知衰退和全脑萎缩4.56个月和4.09个月。

Subjects who received the device’s treatment showed a delay in progression of the disease compared to those in the sham treatment group.

接受该设备治疗的受试者与接受假治疗的受试者相比，疾病进展有所延迟。

Specifically, subjects initially assigned to Spectris AD and later treated with SPECTRIS in the open-label extension study showed a slower progression to the same degree of decline that the sham group experienced during six months.

具体来说，最初分配到Spectris AD组并在开放标签延长期研究中接受SPECTRIS治疗的受试者，显示出进展到与假手术组在六个月内经历的相同程度下降的速度更慢。

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Tailored for at-home use, Spectris AD has been granted breakthrough device designation by the US Food and Drug Administration (FDA) and is now under assessment in the HOPE pivotal trial.

专为家庭使用设计的Spectris AD已获得美国食品和药物管理局（FDA）的突破性设备认定，目前正在进行HOPE关键试验评估。

Cognito Therapeutics CEO Christian Howell said: “Our brains are electrical systems, and Alzheimer’s disrupts the rhythms that govern memory, cognition, and our ability to function.

Cognito Therapeutics首席执行官克里斯蒂安·豪威尔表示：“我们的大脑是电力系统，阿尔茨海默病会扰乱控制记忆、认知和我们功能的节奏。

“Spectris AD represents a new class of therapy, one based in physics, that restores these natural neural oscillations without relying on a chemistry-based pharmacologic therapy. These findings show the potential to meaningfully slow disease progression by leveraging the potential of neuromodulation.”.

“Spectris AD 代表了一种基于物理学的全新疗法，它通过恢复这些自然的神经振荡，而不依赖于化学药物疗法。这些发现展示了通过利用神经调节潜力来有效减缓疾病进展的可能性。”

Last year, Cognito

去年，Cognito

enrolled the first subject

注册了第一个学科

in a biomarker substudy within the HOPE trial evaluating the sensory stimulation device in Alzheimer’s patients.

在HOPE试验中的一项生物标志物子研究，评估阿尔茨海默病患者的感觉刺激装置。

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