CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cognito Therapeutics, a neurotechnology company advancing disease-modifying therapies to treat CNS diseases, presented new data today at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference demonstrating that Spectris™, a disease-modifying treatment, significantly reduced the Alzheimer’s Disease Dependence Score in patients with mild to moderate Alzheimer’s disease.

马萨诸塞州剑桥市（商业新闻短讯）--Cognito Therapeutics是一家神经技术公司，致力于改善疾病治疗以治疗中枢神经系统疾病，今天在第17届阿尔茨海默氏病临床试验（CTAD）会议上提供了新数据，证明Spectris™是一种改善疾病的治疗方法，可显着降低轻度至中度阿尔茨海默氏病患者的阿尔茨海默氏病依赖评分。

The findings were reported from the Phase 2 OVERTURE study, which highlights the potential of Spectris™ in improving patient outcomes and reducing caregiver burden..

第二阶段序曲研究报告了这些发现，该研究强调了Spectris™在改善患者预后和减轻护理人员负担方面的潜力。。

The Alzheimer’s Disease Dependence Score is a 13-item scale directly derived from ADCS-ADL data and is used to evaluate the required amount of assistance from others that a patient with AD needs due to disease progression. It correlates with cognitive decline as measured by MMSE, caregiver burden and healthcare costs..

阿尔茨海默病依赖评分是直接从ADCS-ADL数据中得出的13项量表，用于评估AD患者由于疾病进展而需要的其他人的帮助量。它与MMSE、照顾者负担和医疗保健费用衡量的认知能力下降有关。。

The OVERTURE trial (NCT03556280) evaluated the effectiveness of Spectris™ in a randomized controlled setting, followed by a 12-month open-label extension study. The study included 44 participants who completed the initial trial, with 39 participants evaluated at 9 months and 22 at 18 months. The analysis demonstrated a 56.4% lower AD Dependence Score in the active compared to the sham group, estimated over 18 months (p=0.0396)..

序曲试验（NCT03556280）评估了Spectris™在随机对照环境中的有效性，随后进行了为期12个月的开放标签扩展研究。该研究包括44名完成初始试验的参与者，其中39名参与者在9个月时进行了评估，22名参与者在18个月时进行了评估。分析表明，与假手术组相比，活动组的AD依赖评分降低了56.4%，估计超过18个月（p=0.0396）。。

“Spectris demonstrates a meaningful reduction in dependence associated with Alzheimer’s disease, which not only reflects improved patient function but may also translate to decreased healthcare costs and caregiver time,” said Marwan Sabbagh, M.D., a neurologist in the Alzheimer's and Memory Disorders Program at Barrow Neurological Institute.

巴罗神经研究所阿尔茨海默氏病和记忆障碍项目的神经学家MarwanSabbagh医学博士说：“Spectris显示出与阿尔茨海默氏病相关的依赖性显着降低，这不仅反映了患者功能的改善，还可能转化为医疗保健成本和护理时间的减少。”。

“The findings affirm our commitment to developing therapies that address the needs of patients and their families.”.

“这些发现证实了我们致力于开发满足患者及其家属需求的疗法。”。

Key Findings from the OVERTURE Study:

序曲研究的主要发现：

Significant Reduction in Alzheimer’s Dependence Score: At 18 months, participants in the active treatment group exhibited an estimated change from baseline of +0.96 (95% CI: 0.47–1.44) compared to +2.20 (95% CI: 1.17–3.24) in the sham group (p=0.0396).

阿尔茨海默病依赖评分显着降低：在18个月时，积极治疗组的参与者与基线相比估计变化为+0.96（95%CI:0.47-1.44），而假手术组为+2.20（95%CI:1.17-3.24）（p=0.0396）。

Strong Safety Profile: No cases of ARIA (Amyloid Related Imaging Abnormalities) were reported, and no serious treatment-related adverse events occurred during the open-label extension study.

强烈的安全性：在开放标签扩展研究期间，未报告ARIA（淀粉样蛋白相关成像异常）病例，也未发生严重的治疗相关不良事件。

Cognito Therapeutics also highlighted the importance of diversity in clinical trials during the presentation of the ongoing Phase 3 HOPE study (NCT05637801). The HOPE study has made significant strides in enrolling a participant population that reflects the real-world demographics of Alzheimer’s disease patients.

在正在进行的3期HOPE研究（NCT05637801）的介绍中，Cognito Therapeutics还强调了临床试验多样性的重要性。。

The interim baseline analysis of 467 participants was composed of 88.7% White, 9.0% Black or African-American, 1.7% Asian, and 0.6% Other/Unknown, with 5.6% identifying as Hispanic or Latino..

467名参与者的中期基线分析由88.7%的白人，9.0%的黑人或非裔美国人，1.7%的亚洲人和0.6%的其他/未知人群组成，其中5.6%被确定为西班牙裔或拉丁裔。。

“Diversity in clinical trials is crucial for the development of therapies that can be generalized across representative patient populations,” said Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics. “Our collaboration with the Global Alzheimer’s Platform Foundation (GAP) has enabled us to implement targeted recruitment strategies to enhance participation of underrepresented groups.”.

Cognito Therapeutics首席医疗官、MHSc医学博士拉尔夫·科恩（RalphKern）说：“临床试验的多样性对于开发可以在代表性患者群体中推广的疗法至关重要。”。“我们与全球阿尔茨海默氏症平台基金会（GAP）的合作使我们能够实施有针对性的招聘策略，以增强代表性不足群体的参与。”。

The study utilized a collaboration with GAP to geographically select diverse study sites and implement Diversity, Equity, and Inclusion training for site staff, ensuring culturally competent outreach to diverse communities. The HOPE study demographics are reflective of current US Alzheimer’s disease populations.

该研究利用与GAP的合作，在地理上选择不同的研究地点，并对现场工作人员进行多样性，公平性和包容性培训，确保在文化上有能力拓展到不同的社区。HOPE研究的人口统计数据反映了当前美国阿尔茨海默氏病人群。

The patient demographics in the HOPE study demonstrate that the methods utilized in this study highlight the benefits of targeted site selection and tailored recruitment efforts in diverse communities..

HOPE研究中的患者人口统计数据表明，本研究中使用的方法突出了在不同社区进行有针对性的选址和量身定制的招聘工作的好处。。

Cognito Therapeutics is currently enrolling patients in the ongoing HOPE pivotal trial. For more information visit www.hopestudyforad.com.

Cognito Therapeutics目前正在进行HOPE pivotal试验，招募患者。有关更多信息，请访问www.hopestudyforad.com。

About Cognito Therapeutics

关于认知疗法

Cognito Therapeutics is a late-stage clinical neurotechnology company pioneering disease-modifying treatments for neurodegenerative diseases. Its lead product, Spectris™, uses non-invasive auditory and visual neuromodulation to enhance gamma frequency brain activity, with the goal of slowing brain atrophy and functional decline in Alzheimer's disease.

Cognito Therapeutics是一家晚期临床神经技术公司，开创了神经退行性疾病的疾病缓解治疗。其主要产品Spectris™使用非侵入性听觉和视觉神经调节来增强伽玛频率的大脑活动，目的是减缓阿尔茨海默氏病的脑萎缩和功能下降。

Cognito is committed to developing transformative, technology-driven interventions to address unmet needs in the treatment of CNS diseases. Cognito is headquartered in Cambridge, MA. For more information, visit www.cognitotx.com and follow @cognitotx..

Cognito致力于开发变革性的技术驱动干预措施，以解决中枢神经系统疾病治疗中未满足的需求。Cognito总部位于马萨诸塞州剑桥。有关更多信息，请访问www.cognitotx.com并关注@cognitotx。。