Zervimesine

PURCHASE, N.Y., May 14, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, announced that a second philanthropic donation has been received from a participant in the ongoing expanded access program (EAP) for people with dementia with Lewy bodies (DLB). The ongoing EAP has been extended to provide two years of treatment for participants, thanks to a generous new donation from Mr. Jeffrey Pechter, founding partner of Mindful Capital in Delray Beach, FL. The open-label EAP (COG1202) was launched in 2025 with funding by a generous donation from the family of a DLB patient who was treated in the Phase 2 SHIMMER study. The EAP has since enrolled 32 individuals who are receiving 100 mg of once-daily oral zervimesine, a small molecule investigational therapy designed to protect synaptic function in patients with neurodegenerative diseases. “We continue to be inspired by the high degree of interest in zervimesine from DLB patients and the commitment from people participating in the EAP,” said Lisa Ricciardi, president and CEO of Cognition Therapeutics. “The lack of approved treatments for DLB and the limited availability of clinical research leaves people living with DLB with few options. Due to the overwhelming generosity of our two philanthropic donors, we are able to offer expanded access to zervimesine to the 32 people in our EAP.” James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine, and lead investigator for the EAP, added. “The EAP is a unique opportunity for former participants from the Phase 2 SHIMMER study as well as others who met the EAP’s eligibility criteria to have access to an experimental medication like zervimesine. I’m looking forward to continuing to work with the Cognition team as we learn more about zervimesine’s long-term impact and make plans for a registrational program.” Following positive findings from the completed Phase 2 SHIMMER study, Cognition is scheduled to meet with the FDA Division of Psychiatry to discuss next steps for a registrational program evaluating zervimesine in DLB psychosis. The Company’s plans for the next trial(s) will be further informed by this meeting with the FDA and subsequent meeting minutes, both of which are expected in the second quarter of 2026. About the Expanded Access Program ( EAP) The COG1202 expanded access program (EAP) is an open-label program for eligible SHIMMER participants who completed the Phase 2 study as well as additional patients with a diagnosis of mild-to-moderate DLB who met the enrollment criteria. Dr. James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine is acting as lead investigator for the EAP. As an investigational medicine, zervimesine has not been approved by regulatory authorities. Therefore, the safety and efficacy of zervimesine have not been fully characterized and there may be risks associated with its use. More information is available on clinicaltrials.gov under study identifier NCT06961760. About Cognition Therapeutics Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to helping millions of families seeking effective treatments for devastating neurodegenerative diseases through the development of novel, accessible therapies. The company has led pioneering research into the underlying mechanisms of degenerative nerve disorders. Our scientific approach builds on well-established biological pathways and translates across indications in which toxic oligomers drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer’s disease, geographic atrophy, Parkinson’s, among others. The company’s lead candidate, zervimesine (CT1812), is an investigational once-daily oral therapy that has demonstrated promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer’s disease. Backed by nearly $200 million in National Institutes of Health and related foundation grants, Cognition Therapeutics continues to advance clinical research in its efforts to bring forth solutions that meet patients where they are and reduce caregiver burden. Learn more at cogrx.com . About Zervimesine (CT1812) Zervimesine (CT1812) is currently being studied in the Phase 2 START Study ( NCT05531656 ) in patients with MCI and early Alzheimer’s disease. Phase 2 clinical studies have concluded in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary to dry AMD. Based on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB ( NCT05225415 ), the size of the market and the unmet need, the company plans to advance zervimesine into a late-stage clinical trial for people with DLB psychosis. Zervimesine has been generally well tolerated in clinical studies to date. The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812. Fo rward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, including statements regarding our planned FDA interactions and registrational program for zervimesine, the EAP, and any analyses of the results therefrom, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Global Market; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at . These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact Information: Cognition Therapeutics, Inc. info@cogrx.com Mike Moyer (investors) LifeSci Advisors mmoyer@lifesciadvisors.com This press release was published by a CLEAR® Verified individual.

2026年5月5日，一份被业内视为“金标准”的年度报告发布了。 这份由Jeffrey Cummings博士团队主导、从2016年起每年更新的全球阿尔茨海默药物研发管线报告，今年迎来了第十个年头。 Jeffrey Cummings现任美国内华达大学拉斯维加斯分校教授，在神经科学和阿尔茨海默病领域，已发表了超过900篇论文和44本著作。 他的团队系统追踪全球所有在研的阿尔茨海默药物临床试验，以此为药物研发决策提供参考。 报告显示，截至2026年1月1日，全球共有158种在研药物，分布在192项临床试验中。 而仅仅一年前，这组数字还是138种药物和182项试验。十年前刚开始统计的时候，管线里只有93种药物。 现在，158种药。 192项临床试验。 17种不同的疾病靶点。 过去一年，就新增了59项试验。 线路图上跑着哪些列车？ 为了让大家更直观地理解这158种药物的分布，可以把整个研发管线，想象成一张地铁线路图。 每一条“线路”，代表一种疾病机制。 每一个“站点”，代表一种在研药物。 而“换乘站”，则意味着这种药物可能同时针对多个靶点。 这张地铁图上，一共跑着十七条线路。 而十年间的线路变化，本身就是一个震撼的故事。 2016年刚开始画这张图的时候，淀粉样蛋白线几乎是唯一的“主干线”，占据了全部管线的33%。 几乎所有人都把赌注押在一个逻辑上：清除大脑中的淀粉样蛋白斑块，病情就能好转。 后来的故事，很多人都知道了。 一个又一个药物，在三期临床中折戟沉沙。 从2002年到2012年的十年间，阿尔茨海默药物临床试验的失败率，是99.6%。 一千次尝试，只有四次，走到了终点。 但你看看今天这张地铁图。 十年过去了，淀粉样蛋白线的占比，已经从33%下降到了大约20%。 不是因为这条线路被放弃了。 恰恰相反，这条线上跑出了lecanemab（仑卡奈单抗）和donanemab（多纳奈单抗）这两种已经获批上市的疾病修饰药物。 它的“缩小”，是因为其他线路在迅猛扩张。 “神经炎症线”，从十年前的6%，一路飙升到了约20%。 和淀粉样蛋白线，几乎平起平坐。 越来越多的证据表明，大脑中的慢性炎症，在阿尔茨海默病的进展中扮演着关键角色。 小胶质细胞的过度激活、炎症因子的级联反应，这些曾经被认为是“配角”的病理过程，现在被推到了舞台中央。 “Tau蛋白线”，同样从6%，增长到了约20%。 Tau蛋白的异常磷酸化和缠结，被认为与认知功能下降的关联比淀粉样蛋白更直接。 一些研究者甚至认为，Tau蛋白的病理扩散模式，才是预测患者临床表现的最佳指标。 除了这三条“主干线”之外，还有针对突触可塑性与神经保护、代谢与能量调节、生长因子与激素、蛋白稳态、氧化应激、血管因素、肠脑轴、神经发生、APOE与脂蛋白受体、昼夜节律等方向的细分线路。 总共17种不同的疾病靶点，几乎覆盖了阿尔茨海默病已知的全部病理机制。 这种三线并进、十七路齐发的格局，在十年前是不可想象的。 那时候一条路走不通，整个领域就陷入寒冬。 而现在，任何一条线路出问题，其他线路上的列车还在跑。 三期临床的“头等舱”里坐着谁？ 在这张地铁图中，三期临床试验相当于“头等舱”，是距离终点站（上市）最近的一段旅程。 2026年的管线中，有36种药物正在三期临床中接受检验，涉及54项试验。 其中有几位乘客，格外值得关注。 罗氏公司的trontinemab，是近两年最受瞩目的新星。 这种药物的前身，其实是曾经在三期临床中折戟的gantenerumab。 trontinemab是利用“脑穿梭”（Brainshuttle）技术平台设计的抗Aβ双特异性抗体，和gantenerumab有技术/抗体基础上的关联。 它利用转铁蛋白受体把抗体高效运过血脑屏障，让药物在脑中的浓度大幅提升，同时全身用量却可以降低。 在一项纳入114名患者的早期研究中，接受最高剂量治疗的患者，91%在28周后，淀粉样蛋白斑块转为阴性。 而脑部水肿或出血（ARIA—E）的发生率低于5%。 对比一下，已上市的lecanemab的ARIA—E发生率约13%，donanemab约24%。 罗氏已经启动了三期临床TRONTIER 1和TRONTIER 2，计划招募1600名患者。 还有一项名为PrevenTRON的预防性三期试验，面向临床前人群。 礼来公司也没有闲着。 donanemab（多纳奈单抗，商品名Kisunla）已经在美国、中国、日本相继获批。 但更让人期待的是它的一项预防性试验。 这项试验的受试者，是认知功能正常、但血液检测显示已有早期阿尔茨海默病理改变的人群。 如果数据积累足够，2026年就可能触发分析，届时将揭示一个所有人都想知道的答案，在症状出现之前开始干预，能不能阻止或延缓阿尔茨海默的发生？ Tau蛋白赛道上，强生公司的posdinemab（一种抗Tau单克隆抗体）获得了FDA快速通道资格认定。 关键性二期试验，已完成入组。 强生同时还在推进一种主动免疫的Tau疫苗JNJ—2056，面向临床前阿尔茨海默人群。 百健和Ionis合作的Tau蛋白靶向反义寡核苷酸BIIB080，也完成了二期入组，预计2026年公布数据。 2026年，还有一批令人意外的选手，即将亮相。 8项三期试验，将在今年达到主要完成日期。 其中包括中草药五加益智方、咖啡因（是的，你没看错）、二甲双胍，以及一种PDE5抑制剂AR1001。 这些听起来“不像药”的候选者，背后其实都有严谨的科学支撑。 五加益智方，来自传统中医的经验积累。 二甲双胍，则是基于“阿尔茨海默是三型糖尿病”这一理论展开的探索。 管线中约35%的药物，属于“老药新用”。 把已经在其他疾病中验证过安全性的药物，拿来试治阿尔茨海默。 起点更高，安全数据更充分。 “联合列车”开始上线了 过去，研究者更多是单打独斗，一种药打一个靶点。 但阿尔茨海默病的“地铁系统”如此庞大，单线作战的局限性，已经越来越明显。 管线中已经出现了多项联合治疗的临床试验。 其中一部分，同时针对炎症和淀粉样蛋白两个方向。 还有试验在测试达沙替尼联合槲皮素作为“清除衰老细胞”的疗法。 Eisai正在开展的一项试验更为大胆，把已上市的lecanemab和抗Tau抗体E2814联合使用，试图同时打击淀粉样蛋白和Tau蛋白两个核心靶点。 这就好比地铁开始运行“联合列车”，一趟车能跑两条线路，覆盖更多区域。 这个趋势，具有里程碑意义。 它意味着阿尔茨海默的治疗，正在从“一药一靶”，走向“组合拳”时代。 就像肿瘤领域十几年前经历过的那场变革一样。 未来，一个患者可能同时使用清除淀粉样蛋白的抗体、抑制神经炎症的小分子药、加上改善突触功能的认知增强剂。 每一种药，各负责解决一部分问题。 诊断革命：给地铁装上智能售票机 如果说治疗药物是“列车”，那么诊断工具，就是“售票系统”。 没有准确、便捷的诊断，再好的药，也找不到该坐上车的乘客。 过去诊断阿尔茨海默病，要么靠昂贵的PET扫描，要么靠有创的腰椎穿刺取脑脊液。 很多患者从出现症状到确诊，平均要拖将近三年。 而这三年，恰恰是干预窗口最宝贵的时期。 据估计，高达75%的患者，可能根本没有被诊断出来。 现在，血液生物标志物，正在改变这个局面。 2025年，美国FDA批准了首个用于辅助诊断阿尔茨海默病的血液检测。 只需要抽一管血，检测pTau217与β淀粉样蛋白1-42的比例，就能为大脑中是否存在阿尔茨海默相关变化提供参考。 这项检测并不是给所有健康人做的“体检项目”，主要适用于55岁及以上、已经出现认知症状的人群。 罗氏Elecsys pTau217等检测方案，也已获得FDA突破性器械认定。 在2026年的管线中，血液生物标志物，被越来越多地用作试验的入组条件和主要终点指标。 这意味着什么？ 它意味着未来的阿尔茨海默筛查，会更便利。 在症状出现之前，就能抓住那些大脑里已经开始“铺错轨道”的信号。 而那项donanemab的预防性试验之所以成为可能，正是因为有了这些血液诊断工具，在认知正常的人群中，精准找到已经有病理改变的人。 40Hz伽马波：不走寻常路的新线路 在这张地铁图上，还有一条线路跟其他线路不一样。 它不是药物，而是一种非侵入性的物理干预手段。 2016年前后，MIT Picower学习与记忆研究所的Li-Huei Tsai教授团队率先发现，40Hz节律性的感官刺激，可以增强小鼠大脑中的伽马频率活动。 随后，这一路线从光刺激，扩展到声音刺激和声光联合刺激，并在动物研究中观察到淀粉样蛋白、Tau相关病理、神经元连接等方面的变化。 这种方法被命名为GENUS（Gamma Entrainment Using Sensory Stimuli，即利用感官刺激进行伽马频率夹带）。 此后十年间，全球多个独立研究团队陆续验证了类似发现。 2024年，中国研究团队证实了40Hz感官刺激能增强小鼠脑内类淋巴液的流动，帮助清除代谢废物。 哈佛医学院团队在2022年的一项研究中也发现，40Hz刺激显著降低了四位志愿者中三位的Tau蛋白负荷。 2020年，MIT团队将这项技术推进到人体试验阶段，招募了15名轻度阿尔茨海默患者，每天在家中接受一小时的40Hz声光刺激。 2025年底发表的长期随访数据显示，坚持使用约两年的三位晚发型患者（均为女性），其多项认知指标显著高于国家数据库中可比较的阿尔茨海默患者水平，血浆中的Tau蛋白标志物也有明显下降。 目前国内也有团队在这个方向上，做出了落地产品。 慧悦之音推出的40Hz伽马波脑波仪，运用GammaSync声光同步技术，把40Hz的节律信息同时编码到视觉画面和音频中，让光的闪烁和声音的脉冲精准对齐，每天使用20分钟即可完成一次训练。 设备的设计考虑了老人的使用习惯，操作简单，长按开机，点击即用。 对于有阿尔茨海默家族史或认知下降的家庭，这类声光脑波工具可以作为日常居家辅助手段的一种选择。 29个二期试验等待揭盲 除了那些已经在三期跑道上的选手，2026年还有一批潜力股，正在二期试验中蓄力。 这一年，预计将有29项二期临床试验公布结果，涉及多条完全不同的赛道。 Anavex Life Sciences的Blarcamesine（ANAVEX 2—73），在2025年AAIC大会上展示了四年长期数据，提示了累积获益的可能性。 Cognition Therapeutics的口服小分子CT1812，已经与FDA完成了二期结束会议，正在规划三期试验。 百健和Ionis的Tau蛋白靶向反义寡核苷酸BIIB080，预计今年公布二期数据。 这些结果，将为整个管线的方向提供关键信号：哪些赛道的假说经得起检验，哪些需要调整。 29个二期试验同时揭盲，在阿尔茨海默的研究史上前所未有。 这张地铁图在十年间发生的变化，用数字来说就是，药物数量从93种增长到158种，增幅70%。 临床试验数量，增长了35%。 靶点方向从当初押宝淀粉样蛋白，变成了十七条线路齐头并进。 这些数字都在说明，全球的科研机构和制药公司，正在加速投入。 攻克阿尔茨海默，已不再是遥不可及的奢望。