ANAVEX2-73-RS-003 is a Phase 2/3, double-blind, randomized, placebo-controlled dose escalation safety, tolerability and efficacy study in patients 5-17 years of age with RTT using endpoints including multiple clinical and exploratory molecular and biochemical measures.

开始日期2020-07-01

申办/合作机构

Anavex Life Sciences Corp.

[+2]

NCT04314934

/ Completed临床2/3期

Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004

This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.

开始日期2019-10-10

申办/合作机构

Anavex Life Sciences Corp.

[+2]

NCT04575259

/ Completed临床2期

Open Label Extension Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001

This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and efficacy of daily treatment.

开始日期2019-10-10

申办/合作机构

Anavex Life Sciences Corp.

[+2]

100 项与 Blarcamesine 相关的临床结果

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100 项与 Blarcamesine 相关的转化医学

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100 项与 Blarcamesine 相关的专利（医药）

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项与 Blarcamesine 相关的文献（医药）

2026-04-01·EUROPEAN NEUROPSYCHOPHARMACOLOGY

Emerging neurobiological targets in psychiatric treatment

Review

作者: Berk, Michael ; Govinnage, Janani ; Giorlando, Frank ; De Zoysa, Agampodi Ishan ; Narayanaswamy, J C ; Dodd, Seetal

Despite significant advancements in psychopharmacology, there are inadequate treatment options for many psychiatric disorders, including major depressive disorder, bipolar disorder, schizophrenia, and anxiety disorders. This review explores emerging neurobiological targets beyond conventional monoaminergic approaches, focusing on sodium channels, Neuropeptide Y (NPY), Neurokinin 1 (NK1) receptors, P2 × 7 purinergic receptors, Sigma-1 receptors, and Orexin. Recent evidence suggests that sodium channel modulators, such as evenamide, may offer therapeutic benefits for treatment-resistant schizophrenia by stabilizing glutamatergic neurotransmission. NPY-based therapies have potential in stress-related disorders, foreshadowing rapid anxiolytic and antidepressant effects through modulation of the stress response. NK1 receptor antagonists, although inconsistent in mood disorders, show promise in addiction treatment by reducing substance cravings. The P2 × 7 receptor, a key regulator of neuroinflammation, has been implicated in mood disorders, and its pharmacological inhibition may provide neuroprotective benefits. Additionally, Sigma-1 receptor agonists, including Blarcamesine and Pridopidine, have shown neuroprotective and cognitive-enhancing properties, making them attractive candidates for psychiatric and neurodegenerative disorders. Orexin receptor antagonists, such as suvorexant and seltorexant, have potential in mood disorders and substance dependence, highlighting the broader therapeutic applications of targeting the orexinergic system. While these emerging therapeutic targets hold promise, challenges remain in translating preclinical findings into effective clinical applications. Large-scale, placebo-controlled trials are necessary to establish their efficacy and safety. The identification of biomarkers for patient stratification will be critical in the hitherto elusive goal of developing precision medicine approaches. Targeted pharmacological interventions offer a path toward more effective, well-tolerated, and potentially individualized treatment options for patients with severe mental illness.

2025-12-01·Alzheimers & Dementia

Precision Medicine in Alzheimer’s Disease (AD): Observed Efficacy Treatment Effects from Blarcamesine Clinical AD Trials

Article

作者: Gueddou, Ayoub ; Courreges, Olivier ; Missling, Christopher U ; Guizard, Nicolas ; Lopez‐Talavera, Juan Carlos ; Sabbagh, Marwan N. ; Villa, Luca ; Gabelle, Audrey ; Jin, Kun ; Gordon, Elizabeth ; Chezem, William R. ; Grimmer, Timo ; Borrot, Mathilde

Abstract:

Background:

Precision Medicine represents a transformative approach in treating Alzheimer’s disease (AD), focusing on tailoring interventions based on individual genetic, molecular, clinical and environmental profiles in addition to confirm clear Mechanism of Action (MoA). This strategy aims to optimize treatment outcomes by identifying patient subgroups that are most likely to benefit or benefit at a higher degree from specific therapies, thus reducing inefficacies and potentially adverse effects associated with generalized treatment regimens.

Method:

Blarcamesine, a selective modulator of the Sigma‐1 receptor (SIGMAR1), has garnered attention due to its role in autophagy, cellular stress response, protein homeostasis, and neuroprotection. Recent clinical studies have confirmed its effects in the majority of AD patients who carry the homozygous wild‐type (WT) SIGMAR1 genotype (∼70% of the whole population) (Hampel et al., 2020).

Result:

In the Phase IIb/III ANAVEX2‐73‐AD‐004 trial, a clear MoA of oral once daily blarcamesine, a pre‐specified efficacy analysis confirmed the importance of SIGMAR1 to clinical response. While all trial participants improved significantly versus placebo after 48 Weeks, 36.3% for ADAS‐Cog13 and 27.6% for CDR‐SB, respectively, a further, also significant, improvement was observed in the prespecified analysis of SIGMAR1 carriers. Compared to the ITT group, participants carrying the SIGMAR1 WT gene observed further improvement versus placebo of 49.8% and 33.7% for the primary and secondary key endpoints ADAS‐Cog13 and CDR‐SB, respectively (Macfarlane et al., 2025).

Conclusion:

Thus, the specificity of blarcamesine to this genotype underscores the importance of understanding clear MoA and potential for further improved personalized medicine in AD treatment, as therapies targeting individual molecular profiles could achieve more substantial and sustained benefits. While Precision Medicine holds great promise for improving the treatment paradigm of AD by offering more personalized, likely more effective therapies, it also introduces challenges related to potential cost, data privacy, ethical concerns, and inequities in access. Addressing these issues is crucial to ensure that the benefits of Precision Medicine can be realized for all patients.

2025-12-01·Alzheimers & Dementia

Phase IIb/III ATTENTION‐AD Study: Over Three Years of Continuous Treatment with Oral Blarcamesine Continues to Significantly Benefit Early Alzheimer’s Disease Patients

Article

作者: Sabbagh, Marwan N. ; Chezem, William R. ; Gabelle, Audrey ; Jin, Kun ; Macfarlane, Stephen ; Lopez‐Talavera, Juan Carlos ; Grimmer, Timo ; Missling, Christopher U

Abstract:

Background:

There are no approved oral disease‐modifying small molecule therapies for treatment of early Alzheimer’s disease (AD). Blarcamesine is an orally bioavailable small molecule that enhances autophagy through SIGMAR1 activation and restoration of cellular homeostasis in early AD.

Method:

The ATTENTION‐AD study was an up to 144‐week open‐label extension study subsequent the 48‐Week Phase IIb/III double‐blind placebo‐controlled ANAVEX ® 2‐73‐AD‐004 study, to evaluate the safety and efficacy of oral once daily blarcamesine in 508 participants with early AD. Delayed‐start analysis was performed to assess the effect of early treatment initiation up to 192 Weeks.

Result:

The ATTENTION‐AD trial confirmed the good efficacy and safety profile of once daily oral blarcamesine and also demonstrated the manageable nature of the most frequent treatment emergent adverse event (TEAE) (dizziness) observed in the preceding ANAVEX ® 2‐73‐AD‐004 trial, which was generally transient in duration (approx. 7‐11 days) and mild or moderate in severity (Grade 1 or 2). The titration schedule was adjusted to a slightly longer titration period in the ATTENTION‐AD trial, from previous 2‐3 weeks to 10 weeks. A markedly lower frequency of the TEAE of dizziness in the respective maintenance phase was observed: from previously 25.2% in the ANAVEX ® 2‐73‐AD‐004 trial to 9.6% in the ATTENTION‐AD trial, demonstrating the manageable nature of this TEAE. No severe or life‐threatening adverse events were attributed to blarcamesine. No Amyloid Related Imaging Abnormalities (ARIA) adverse events were identified. There were no deaths related to blarcamesine. Efficacy of the cognitive and functional endpoints in the delayed‐start analysis of treatment resulted in significant outcomes, ADAS‐Cog13 (LS mean difference ‐3.83, P = 0.0165) and ADCS‐ADL (LS mean difference +4.30, P = 0.0206) at Week 192, reflecting importance of early treatment initiation with oral blarcamesine.

Conclusion:

Blarcamesine significantly reduced clinical decline showing meaningful benefit for early Alzheimer’s disease patients. Blarcamesine exhibited a favorable safety profile with no treatment‐related deaths and demonstrated no associated neuroimaging adverse events with continued treatment over 4 years. Altogether, these results indicate that blarcamesine may be an effective, safe, and novel scalable oral treatment for early AD.

203

项与 Blarcamesine 相关的新闻（医药）

2026-05-25

·李乐教授

看完《给阿嬷的情书》，聊聊阿尔茨海默症的治疗进展

昨天看完了《给阿嬷的情书》，最后谢南枝得了阿尔茨海默症，已经不记得太多以前的事情了，但是最后还记得给木生一家邮寄腌猪肉，那一段把我看哭了。看到阿尔茨海默症，正好对这个病的用药有一点研究，就想着聊两句吧。阿尔茨海默症简称AD，俗称老年痴呆，是一种缓慢进展的神经退行性疾病。患者逐渐失去记忆，最后连身边的人都不认识了。过去几十年里，医务工作者没有太好的办法根除疾病的影响，只能一点一点看着疾病发展，多奈哌齐和美金刚算是有一些效果的上市药物，但是也无法阻止疾病的发展，像撒切尔夫人这样的外国领导人，得了这个病也是没有太多办法的。时间到了2023年，美国FDA批准了一个新药治疗阿尔茨海默症，叫做仑卡奈单抗（Lecanemab，商品名Leqembi），随后多奈单抗也获批上市，这两个药物直接作用疾病的可能发病机制，大脑中异常沉淀的β-淀粉样蛋白（Aβ）。我们可以把这个蛋白理解成大脑里的垃圾，健康大脑会及时清理这些蛋白，但是得了阿尔茨海默症，这些蛋白会逐渐聚集，最终形成板块，破坏大脑细胞，影响认知。这两个药物属于单克隆抗体，可以作用于这些斑块或者形成斑块的中间状态，临床试验显示他们让患者的认知下降速度明显减缓。 2026年礼来公司还推进了下一代药物remternetug的3期临床试验，这个药物可以像胰岛素一样在家里自己注射，不用经常去医院静脉输液。除了皮下注射，药物研发专家也在努力研究口服抗阿尔茨海默症的药物。目前有一个口服药还是比较有希望的，叫做blarcamesine，正在临床试验。罗氏公司开发了的一个叫做trontinemab的药物，这个药采用了罗氏独有的脑穿梭技术，听起来很酷，可以解决药物穿透血脑屏障的难题。2025年下半年已经进入了三期临床阶段，如果成功，意义非凡。除了抗体药物，还有小核酸药物疗法，主要针对的是tau蛋白，这个也是阿尔茨海默症的另外一个病理标志，目前Arrowhead公司研发的一款药物预计在26年下半年公布临床数据。如果成功，同样意义非凡。好消息说完了，下面说说坏消息。新药也是有一些风险的，极少数情况下可能引发癫痫或者其他。另外这些药物主要用于早期轻度患者，中重度患者，并没有明显获益。所以阿尔茨海默症治疗的关键原则是，越早干预效果越好。我国在25年年底将仑卡奈单抗纳入首批商业保险创新药目录，让不少家庭减轻了负担。未来，单一药物可能无法攻克这个疾病，科学家在探索治疗艾滋病一样采用鸡尾酒疗法，多个药物协同。还有一些非药物治疗，也证明对于延缓认知衰退有一定的帮助。虽然电影的结局无法改变，但是医学正在改写这个疾病的结局，今天，我们第一次拥有了干预疾病进展的武器，它虽不能治愈，但足以让患者多几个月甚至几年的独立生活能力。如果你或家人出现了记忆力明显减退、语言表达困难等早期症状，请及时到神经内科或记忆门诊就诊。行舟入夜，恰江上升明月，似与你并肩重归。病程万里，药在身旁，便不觉无望。

2026-05-22

·anavex.com

Anavex Life Sciences Receives Expected Nasdaq Delinquency Notification

About UsTeam Careers ConditionsAlzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Therapeutic CandidatesBlarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 PatientsSIGMACEPTOR InvestorsInvestor Resources Events Analyst Coverage Corporate Governance Share Data News Team Careers Alzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Blarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 SIGMACEPTOR Investor Resources Events Analyst Coverage Corporate Governance Share Data About UsTeam Careers ConditionsAlzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Therapeutic CandidatesBlarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 PatientsSIGMACEPTOR InvestorsInvestor Resources Events Analyst Coverage Corporate Governance Share Data News Team Careers Alzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Blarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 SIGMACEPTOR Investor Resources Events Analyst Coverage Corporate Governance Share Data About UsTeam Careers ConditionsAlzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Therapeutic CandidatesBlarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 PatientsSIGMACEPTOR InvestorsInvestor Resources Events Analyst Coverage Corporate Governance Share Data News Team Careers Alzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Blarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 SIGMACEPTOR Investor Resources Events Analyst Coverage Corporate Governance Share Data About UsTeam Careers ConditionsAlzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Therapeutic CandidatesBlarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 PatientsSIGMACEPTOR InvestorsInvestor Resources Events Analyst Coverage Corporate Governance Share Data News Team Careers Alzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Blarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 SIGMACEPTOR Investor Resources Events Analyst Coverage Corporate Governance Share Data NEW YORK, NY, May 22, 2026 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for central nervous system (CNS) disorders, today announced it received an expected delinquency notification letter (the “Notice”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) on May 20, 2026. The Notice indicates that the Company is not in compliance with Nasdaq Listing Rule 5250(c)(1) (the “Nasdaq Listing Rule”) as a result of the Company’s inability to timely file its Form 10-Q for the quarterly period ended March 31, 2026. As indicated in the Notice, the Company has until July 20, 2026, to submit a plan to regain compliance. The Company is working prudently to complete and file the Form 10-Q and submit a plan to regain compliance with the Nasdaq Listing Rule. This notification has no immediate effect on the Company’s common stock listed on Nasdaq. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders. Further information is available at www.anavex.com. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements relating to the Company’s plans to complete and file its Form 10-Q and to submit a plan to regain compliance with Nasdaq Listing Rule 5250(c)(1). These statements are based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such forward-looking statements due to various factors, including, but not limited to, risks related to the Company’s ability to file the Form 10-Q and the Company’s ability to regain compliance with Nasdaq Listing Rule 5250(c)(1) and other risks and uncertainties set forth in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025, and subsequent filings and furnishings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof except as required by law. Investor Relations & Media Contact: SCR Partners, LLC Alex Arzeno Tel: 203-550-3972 Email: alex@scr-ir.com Tripp Sullivan Tel: 615-942-7077 Email: tsullivan@scr-ir.com Company Contact: Sandra Boenisch Principal Financial Officer Anavex Life Sciences Corp. Tel: 1-844-689-3939 Email: ir@anavexcorp.com Anavex is dedicated to advancing brain health by developing innovative oral medicines designed to improve patients lives. Alzheimer’s Disease Parkinson’s Disease Schizophrenia Rett Syndrome Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Alzheimer’s Disease Parkinson’s Disease Schizophrenia Rett Syndrome Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Corporate Presentation Therapeutic Candidates Investor Resources Share Data Events Careers Our Values A Letter from the CEO Corporate Presentation Therapeutic Candidates Investor Resources Share Data Events Careers Our Values A Letter from the CEO Receive updates directly to your inbox on company announcements, clinical progress, and regulatory developments. Forward Looking Statement Code of Conduct Legal Notice Privacy Policy Contact Forward Looking Statement Code of Conduct Legal Notice Privacy Policy Contact

2026-05-10

·百度百家

全球158种新药同时在路上！一张图看懂2026阿尔茨海默治疗管线

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。

100 项与 Blarcamesine 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11383	Blarcamesine	-	DB05592

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
阿尔茨海默症	申请上市	欧盟	Anavex Life Sciences Corp.	2023-11-20
认知功能障碍	申请上市	欧盟	Anavex Germany GmbH	2023-11-20
Rett综合征	临床3期	澳大利亚	Anavex Life Sciences Corp.	2019-05-06
Rett综合征	临床3期	英国	Anavex Life Sciences Corp.	2019-05-06
脆性X综合征	临床3期	美国	Anavex Life Sciences Corp.	-
帕金森病所致痴呆	临床2期	澳大利亚	Anavex Life Sciences Corp.	2018-07-09
帕金森病所致痴呆	临床2期	西班牙	Anavex Life Sciences Corp.	2018-07-09
帕金森病	临床2期	澳大利亚	Anavex Life Sciences Corp.	2018-07-09
帕金森病	临床2期	西班牙	Anavex Life Sciences Corp.	2018-07-09
天使综合征	临床1期	-	Anavex Life Sciences Corp.	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04314934 (ATTENTION-AD, GlobeNewswire) 人工标引	临床2/3期	阿尔茨海默症	-	Blarcamesine (the early-start treatment groups)	憲積製廠鑰構鏇醖築憲(製餘獵餘繭壓夢憲壓憲): Difference (LS Mean) = -3.83, P-Value = 0.0165 更多	积极	2025-07-31
				Blarcamesine (the late-start treatment groups)
NCT04314934 (ATTENTION-AD, GlobeNewswire) 人工标引	临床2/3期	阿尔茨海默症	-	blarcamesine (early start treatment)	範憲願廠積壓餘獵簾簾(簾艱廠簾廠製觸構壓簾) = from previously 25.2% in the ANAVEX®2-73-AD-004 trial to 9.6% in the ATTENTION-AD trial. 艱醖襯鏇廠窪壓鹽鬱鹹 (壓夢選範淵構獵衊築顧 ) 更多	积极	2025-01-13
				blarcamesine (late start treatment)
NCT04314934 (GlobeNewswire) 人工标引	临床2/3期	阿尔茨海默症	-	Blarcamesine 50 mg	醖鬱膚鹹獵遞簾壓憲選(構網網鑰壓鑰觸鹹積鏇) = 齋願構積網積醖襯餘鬱願衊膚遞襯構艱壓願獵 (觸積齋網築鹹廠襯窪簾 ) 更多	积极	2024-07-28
				Blarcamesine 30 mg	醖鬱膚鹹獵遞簾壓憲選(構網網鑰壓鑰觸鹹積鏇) = 簾願鹹艱顧襯鏇淵簾積願衊膚遞襯構艱壓願獵 (觸積齋網築鹹廠襯窪簾 ) 更多
NCT04304482 (EXCELLENCE, GlobeNewswire) 人工标引	临床2/3期	Rett综合征	92	ANAVEX2-73	蓋獵鹹願糧簾齋糧蓋鑰(獵蓋鑰繭鹹憲網廠餘鹽) = 蓋蓋蓋糧衊簾醖鹹鹽醖構齋製網齋憲窪糧蓋餘 (餘積夢簾鏇壓獵窪鹹構, 2.150) 更多	积极	2024-01-02
				Placebo	蓋獵鹹願糧簾齋糧蓋鑰(獵蓋鑰繭鹹憲網廠餘鹽) = 醖醖遞齋積鹹願憲襯構構齋製網齋憲窪糧蓋餘 (餘積夢簾鏇壓獵窪鹹構, 2.537) 更多
NCT03790709 (Corporate Publications) 人工标引	临床2/3期	阿尔茨海默症	508	ANAVEX2-73	鹹顧構壓糧積膚鏇鏇網(憲選網遞繭壓積廠淵鏇): Difference = -1.783 (95% CI, −3.314 ~ −0.251), P-Value = 0.0226 达到更多	积极	2023-09-14
				Placebo
NCT03790709 (ANAVEX2-73-AD-004, GlobeNewswire) 人工标引	临床2/3期	阿尔茨海默症	509	Blarcamesine	鹹獵餘獵窪壓淵製範獵(夢鬱蓋製顧夢積簾餘鬱): OR = 1.84, P-Value = 0.015 更多	积极	2022-12-01
				Placebo
NCT03758924 (Biospace) 人工标引	临床2期	Rett综合征 SIGMAR1	-	Blarcamesine	鬱憲淵積鏇繭網鏇艱願(網鹽窪選製窪顧積窪憲) = 窪蓋蓋齋顧築齋顧遞淵鹽網膚繭憲選艱獵繭獵 (衊壓夢選鬱廠夢製憲積 ) 更多	积极	2021-06-21
				Placebo	-
CTAD2015	临床2期	-	-	ANAVEX 2-73	醖廠網鑰膚築壓築積艱(觸鏇簾襯醖蓋繭襯糧窪) = The average Cogstate test improved across the test batteries 膚鹽觸鬱蓋選範鹽築簾 (願鏇鑰範憲壓構製築鏇 ) 更多	积极	2015-11-04