A Phase Ib/IIa Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Doses, Regimens and Combinations of Tau Targeted Vaccines in Subjects With Early Alzheimer's Disease

This study is a multicenter, double blind, randomized, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of different doses, regimens and combinations of Tau targeted vaccines in participants with early Alzheimer's Disease.

开始日期2019-07-31

申办/合作机构

AC Immune SA

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100 项与 JACI-35.054 相关的临床结果

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100 项与 JACI-35.054 相关的转化医学

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100 项与 JACI-35.054 相关的专利（医药）

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项与 JACI-35.054 相关的文献（医药）

2025-10-01·EBioMedicine

Safety and immunogenicity of two Tau-targeting active immunotherapies, ACI-35.030 and JACI-35.054, in participants with early Alzheimer's disease: a phase 1b/2a, multicentre, double-blind, randomised, placebo-controlled study

Article

作者: Börjesson-Hanson, Anne ; Jonsson, Michael ; Hliva, Valérie ; Kosco-Vilbois, Marie ; Pfeifer, Andrea ; Gerasymchuk, Viktoriia ; Sol, Olivier ; Hallikainen, Merja ; Fournier, Nicolas ; Rinne, Juha ; Dautzenberg, Paul ; Streffer, Johannes ; Steukers, Lennert ; Kurl, Sudhir ; Vijverberg, Everard G B ; Scheltens, Philip ; Theunis, Clara ; Gollwitzer, Eva ; Mummery, Catherine ; Fiorini, Emma ; Gray, Julian ; Ritchie, Craig ; Wagg, Jonathan ; Kezic, Iva ; Mermoud, Julien ; Vukicevic, Marija ; Triana-Baltzer, Gallen ; Hickman, David T ; Pennington, Catherine ; Lê, Bénédicte

BACKGROUND:

Active immunotherapies targeting C-terminal phosphorylated Tau species have the potential to efficiently reduce Tau spreading. ACI-35.030, a SupraAntigen®-based liposome, and JACI-35.054, a CRM197 carrier-protein conjugate, share the same immunogenic pTau sequence and were assessed to determine the best formulation for preferential activation of B cells specific to pathological Tau forms.

METHODS:

Individuals with early AD were enrolled in this randomised, double-blind, placebo-controlled study (NCT04445831). Participants were randomly assigned to 2 cohorts (ACI-35.030 at 300, 900, 1800 μg or placebo; and JACI-35.054 at 15, 60 μg or placebo) and received 4 intramuscular injections over 48 weeks, followed up to week 74. Participants receiving at least one dose of study drug were included in the intention-to-treat analysis. The primary objectives were safety, tolerability and immunogenicity.

FINDINGS:

Among the 57 randomised participants, 41 were assigned to the ACI-35.030 cohort and 16 to the JACI-35.054 cohort. The most frequent adverse events observed consistently in both active groups were injection site reactions (16.7%-100%) and headaches (16.7%-50%). No relevant MRI findings and no adverse events leading to study discontinuation were reported. ACI-35.030 required only one injection to induce anti-pTau IgG titres in all participants and consistently boosted levels with subsequent immunisations. JACI-35.054 raised a strong but more heterogenous anti-pTau IgG response and required multiple administrations to reach consistent titres in all participants. ACI-35.030 induced a robust polyclonal antibody response binding enriched PHF from AD brain tissue while concurrently sparing the response to non-phosphorylated Tau. A post-hoc statistical analysis revealed statistically significant differences between some randomised actively treated groups and the pooled placebo group on plasma pTau217 and brain-derived Tau changes from baseline.

INTERPRETATION:

ACI-35.030 and JACI-35.054 were well tolerated. ACI-35.030 induced a more rapid and sustained antibody response selective to p-Tau species with evidence of altering AD-related plasma biomarkers and was selected for testing in the ongoing Phase 2b trial.

FUNDING:

AC Immune SA and Johnson & Johnson Innovative Medicine.

项与 JACI-35.054 相关的新闻（医药）

2025-09-29

·药明康德

一针起效，应答率达100%的多肽疫苗；使关键靶蛋白降解率超80%的口服小分子疗法…… | 一周盘点

本期看点 1. 用于治疗阿尔茨海默病的多肽疫苗ACI-35.030的1b/2a期临床试验结果积极，仅需1次注射即可让所有受试者产生抗磷酸化Tau（pTau）IgG抗体滴度，2周时所有剂量组的应答率达100%。 2. 口服小分子IKZF1/3蛋白降解剂cemsidomide联合地塞米松治疗复发/难治性多发性骨髓瘤（RRMM）的1期临床试验数据积极，最高剂量组的总缓解率（ORR）达50%，关键靶蛋白IKZF1的降解率＞50%，IKZF3降解率＞80%。 ACI-35.030（JNJ-2056）：公布1b/2a期临床试验数据 AC Immune公司公布了其用于治疗阿尔茨海默病的免疫疗法ACI-35.030的1b/2a期临床试验结果。ACI-35.030基于AC Immune的SupraAntigen技术平台开发，该技术将pTau肽锚定在脂质体中，同时包含非Tau T细胞表位和佐剂。试验还研究了另一种免疫疗法JACI-35.054，两种疗法针对同一靶点。临床数据显示，针对同一靶点的两种不同主动免疫疗法制剂，能在早期阿尔茨海默病患者体内诱导产生有差异的抗体反应。安全性方面，ACI-35.030和JACI-35.054均未报告任何具有临床意义的安全性或耐受性问题。ACI-35.030仅需一次注射即可使所有受试者产生抗pTau IgG抗体滴度，并在后续接种中持续提升抗体水平。在接受ACI-35.030治疗后2周时，所有剂量组的所有受试者均被认定为抗pTau IgG应答者。在两个高剂量组中，应答率在第74周时仍维持在94%至100%之间。目前，ACI-35.030已被选中推进至关键性2b期ReTain临床试验，用于治疗临床前期阶段的阿尔茨海默病。 Cemsidomide：公布1期临床试验数据 C4 Therapeutics公司公布了其在研口服小分子IKZF1/3蛋白降解剂cemsidomide联合地塞米松治疗复发/难治性多发性骨髓瘤的1期临床试验数据。截至2025年7月23日的数据，在接受过多线治疗的RRMM患者中，cemsidomide联合地塞米松展现出强劲且持久的抗肿瘤活性。最高剂量组（100 µg）患者的ORR达50%；75 µg剂量组的ORR为40%。所有剂量组的中位缓解持续时间（DOR）为9.3个月，在两个最高剂量组中，中位缓解持续时间尚未达到。药效学（PD）结果显示，cemsidomide与地塞米松联用可高效降解靶蛋白并激活T细胞，在人外周血单核细胞中，IKZF1的降解率＞50%、IKZF3降解率＞80%，且在所有剂量下均显著增强T细胞活化和IL-2等细胞因子的产生，展现出与地塞米松联用或与地塞米松+BCMA双特异性T细胞衔接器（BCMA BiTE）联用的潜力。安全性方面，没有与cemsidomide相关的停药事件，且很少有剂量减少事件（6%），为其在联合治疗方案中的广泛应用提供了有力支持。 SYT-510：公布1期临床试验数据 Synendos Therapeutics公司公布了其核心候选药物SYT-510在健康受试者中开展的1期临床试验的积极结果。SYT-510靶向内源性大麻素系统（ECS）中一个新近发现的靶点，属于新型ECS调节剂——选择性内源性大麻素再摄取抑制剂（SERIs）类别。研究结果表明，SYT-510在所有剂量下均具有良好的耐受性，安全性良好。药代动力学（PK）数据显示，SYT-510能够穿透血脑屏障，在中枢神经系统（CNS）中达到有效浓度。该药物展现出明确的脑部药效学作用，其对脑电图（EEG）的影响与成功用于控制焦虑症状的抗焦虑药物一致。 MF-300：公布1期临床试验数据 Epirium Bio公司宣布，其潜在“first-in-class”的口服15-羟基前列腺素脱氢酶（15-PGDH）抑制剂MF-300，在针对肌肉减少症的1期临床试验中取得积极结果。5-PGDH是一种能将前列腺素E2（PGE2）转化为非活性代谢物的酶。MF-300旨在可逆地结合到15-PGDH的PGE2结合位点上，阻止该酶转化PGE2。在生化试验中，MF-300能够抑制15-PGDH的活性。在临床前的细胞和动物研究中，MF-300可稳定和增加PGE2的水平。此次试验达到了主要安全性终点，所有研究剂量的MF-300总体耐受性良好，且无受试者因不良反应而退出。MF-300呈现出剂量依赖性的PD应答，该应答出现较早并随时间的推移持续存在，而安慰剂组则未观察到显著变化，表明药物成功与靶点结合并具有生物学活性。PK分析显示，药物暴露量随剂量增加而上升，其半衰期支持每日一次口服给药方案。参考资料： [1] Intellia Therapeutics Announces Positive Longer-Term Phase 1 Data for Nexiguran Ziclumeran (nex-z) in Patients with Hereditary Transthyretin (ATTR) Amyloidosis with Polyneuropathy. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/25/3156402/0/en/Intellia-Therapeutics-Announces-Positive-Longer-Term-Phase-1-Data-for-Nexiguran-Ziclumeran-nex-z-in-Patients-with-Hereditary-Transthyretin-ATTR-Amyloidosis-with-Polyneuropathy.html [2] Bambusa Therapeutics Announces Highly Positive Healthy Volunteer Results and First Atopic Dermatitis Patient Dosed in Phase I Trial of BBT001. Retrieved September 26, 2025, from https://www.prnewswire.com/news-releases/bambusa-therapeutics-announces-highly-positive-healthy-volunteer-results-and-first-atopic-dermatitis-patient-dosed-in-phase-i-trial-of-bbt001-302567230.html [3] Rallybio Completes Dosing of First Cohort in RLYB116 Phase 1 Confirmatory Pharmacokinetic/Pharmacodynamic Study. Retrieved September 26, 2025, from https://www.businesswire.com/news/home/20250924016253/en/Rallybio-Completes-Dosing-of-First-Cohort-in-RLYB116-Phase-1-Confirmatory-PharmacokineticPharmacodynamic-Study [4] uniQure Announces Positive Topline Results from Pivotal Phase I/II Study of AMT-130 in Patients with Huntington’s Disease. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/24/3155348/0/en/uniQure-Announces-Positive-Topline-Results-from-Pivotal-Phase-I-II-Study-of-AMT-130-in-Patients-with-Huntington-s-Disease.html [5] Kyverna Therapeutics Highlights Potential of KYV-101 in Multiple Sclerosis with Data from Phase 1 Investigator-Initiated Trials to be Presented at ECTRIMS. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/24/3155539/0/en/Kyverna-Therapeutics-Highlights-Potential-of-KYV-101-in-Multiple-Sclerosis-with-Data-from-Phase-1-Investigator-Initiated-Trials-to-be-Presented-at-ECTRIMS.html [6] Epirium Bio Announces Positive Phase 1 Clinical Trial Results Evaluating MF-300 in Healthy Volunteers, A First-In-Class, Oral 15-PGDH Enzyme Inhibitor, For the Treatment of Sarcopenia. Retrieved September 26, 2025, from https://www.businesswire.com/news/home/20250924461947/en/Epirium-Bio-Announces-Positive-Phase-1-Clinical-Trial-Results-Evaluating-MF-300-in-Healthy-Volunteers-A-First-In-Class-Oral-15-PGDH-Enzyme-Inhibitor-For-the-Treatment-of-Sarcopenia [7] Actio Biosciences Announces First Participant Dosed in Phase 1 Clinical Trial of ABS-1230, a KCNT1 Inhibitor for the Treatment of KCNT1-Related Epilepsy. Retrieved September 26, 2025, from https://actiobiosciences.com/actio-biosciences-announces-first-participant-dosed-in-phase-1-clinical-trial-of-abs-1230-a-kcnt1-inhibitor-for-the-treatment-of-kcnt1-related-epilepsy/ [8] CellProthera announces peer-reviewed publication of its Phase I/IIb results on safety and feasibility of ProtheraCytes® in patients with severe heart failure post-myocardial Infarction. Retrieved September 26, 2025, from https://www.cellprothera.com/en/cellprothera-announces-peer-reviewed-publication-of-its-phase-i-iib-results-on-safety-and-feasibility-of-protheracytes-in-patients-with-severe-heart-failure-post-myocardial-infarction/ [9] MIRA Pharmaceuticals Announces Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled Ketamine Analog. Retrieved September 26, 2025, from https://mirapharmaceuticals.com/mira-pharmaceuticals-announces-favorable-topline-results-from-phase-1-sad-study-of-oral-ketamir-2-a-next-generation-non-scheduled-ketamine-analog/ [10] Ionis announces positive topline results from pivotal study of zilganersen in Alexander disease. Retrieved September 26, 2025, from https://secure.businesswire.com/news/home/20250922674696/en/Ionis-announces-positive-topline-results-from-pivotal-study-of-zilganersen-in-Alexander-disease [11] Skye Presents Phase 1b Data for its Peripheral CB1-inhibiting Antibody, Nimacimab, at European Association for the Study of Diabetes (EASD) Annual Meeting. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/19/3153078/0/en/Skye-Presents-Phase-1b-Data-for-its-Peripheral-CB1-inhibiting-Antibody-Nimacimab-at-European-Association-for-the-Study-of-Diabetes-EASD-Annual-Meeting.html [12] C4 Therapeutics Presents Cemsidomide Phase 1 Multiple Myeloma Data Supporting Potential Best-in-Class Profile at the International Myeloma Society Annual Meeting. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/20/3153507/0/en/C4-Therapeutics-Presents-Cemsidomide-Phase-1-Multiple-Myeloma-Data-Supporting-Potential-Best-in-Class-Profile-at-the-International-Myeloma-Society-Annual-Meeting.html [13] Synendos Therapeutics Reports Positive and Highly Promising Topline Results from Phase 1 Trials, Paving the Way for Phase 2 in Mental Health. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/24/3155178/0/en/Synendos-Therapeutics-Reports-Positive-and-Highly-Promising-Topline-Results-from-Phase-1-Trials-Paving-the-Way-for-Phase-2-in-Mental-Health.html [14] Peer-reviewed results from Phase 1b/2a Trial of Anti-pTau Active Immunotherapy from AC Immune Published in eBioMedicine. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/25/3156158/0/en/Peer-reviewed-results-from-Phase-1b-2a-Trial-of-Anti-pTau-Active-Immunotherapy-from-AC-Immune-Published-in-eBioMedicine.html 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床2期免疫疗法疫苗临床1期

2023-06-29

·药智网

股价大涨72%！阿尔茨海默症疫苗，下一个金矿？

近日，位于瑞士的创新型公司AC Immune发布公告称，在研的治疗阿尔茨海默病（AD）的Aβ疫苗ACI-24.060获得美国FDA突破性疗法资格认定。消息一出，公司股价当日大涨71.72%。阿尔茨海默症疫苗，又再一次站在镁光灯之下。图1 AC Immune公司官宣图片来源：AC Immune公司官网全球AD领域布局TOP10，AC Immune在研管线解读AC Immune成立于2003年，是一家在纳斯达克上市的瑞士临床阶段生物制药公司，致力于研发治疗AD等神经退行性疾病的治疗药物和诊断试剂。针对以阿尔茨海默症为代表的多种神经退行性疾病，AC Immune开发了小分子药物、单抗药物、疫苗和τ蛋白PET示踪剂和疫苗，目前在研管线18项，已进入临床的有11项。在研管线中，进展最快的AD药物是τ蛋白示踪剂PI-2620，目前已进入III期临床研究阶段。AC Immune是全球在AD领域耕耘最多的top10公司之一，并于与罗氏、礼来、强生等制药巨头达成了合作关系。图2 AC Immune公司已进入临床研究阶段的管线图图片来源：AC Immune公司官网图3 AC Immune公司处于临床前研究阶段的管线图图片来源：AC Immune公司官网近日获得FDA突破性疗法认定的Aβ疫苗ACI-24.060，是基于公司SupraAntigen平台开发的阿尔茨海默症疫苗，它可以驱动淀粉样蛋白沉积和AD疾病进展的Aβ产生抗体反应，具有抑制Aβ形成的潜力，以达到延缓或预防AD进展的治疗效果。今年2月，AC Immune公司公布了ACI-24.060用于治疗AD的Ib/II期ABATE研究的中期结果，显示ACI-24.060在最初的低剂量队列中表现出良好的耐受性，未发现安全问题。同时，低剂量ACI-24.060在接种后的第六周就显示出了抗Aβ抗体反应。ABATE是一项双盲、随机和安慰剂对照研究，旨在评估ACI-24.060的安全性、耐受性、药效学特征和免疫原性。这项试验分为两部分:第一部分包括早期AD惠者或因AD导致的轻度认知障碍患者，第二部分将招募唐氏综合征患者，他们患AD的风险较高。基于上述积极结果，接种高剂量ACI-24.060的AD患者队列已经启动。与此同时，ABATE研究的DS队列也已招募了患阿尔茨海默病风险较高的唐氏综合征（DS）患者。这也标志着首次研究针对唐氏综合症患者的抗Aβ疫苗的出现。在研管线20项，阿尔茨海默症疫苗盘点阿尔茨海默病素来有“研发黑洞”之说，一直是研发企业的“碎钞机”，不少大厂都铩羽而归。但是根据2022年世界阿尔茨海默病报告，目前全球有5500多万人被诊断患有AD，市场规模超过230亿美元。预计到2050年，这一数字可能会超过1.3亿。该报告还强调了早期发现和诊断AD的重要性。据估计，全球有多达75%的痴呆患者未被诊断，对应着，疫苗的研发重要性就进一步凸显，这一块潜力蛋糕测算至少近1000亿美元。据药智数据显示，目前全球范围内针对阿尔茨海默病的疫苗研发管线有20项，目前仅有GemVax&Kael Co Ltd研发的特托莫肽（tertomotide）获批上市。此外，处于临床研究III期的有1项，是诺华制药的CAD-106；处于临床II期的有8项，处于临床I期的有6项，暂时未有在国内开展临床研究。在疫苗领域，管线布局最多的公司是AC Immune公司，共有4项，分别为与杨森制药合作的ACI-35.030、JACI-35.054和ACI-35，以及前述获得突破性疗法认定的ACI-24.060。表1 全球阿尔茨海默病疫苗研发进展数据来源：药智数据此外，在阿尔茨海默症上折戟沉沙的案例数不胜数，其能成功研发可谓“九死一生”。因此，获得特殊通道认可，一定程度上是“希望的曙光”。根据药智数据，目前在全球范围内针对阿尔茨海默症的709项管线中，获得特殊审评通道的药物有24项，其中获得优先评审的有14项，获得突破性疗法的有10项。在这24项中，仅有ACI-24.060是疫苗类获得突破性疗法认定，这也就完美地解释了公司股价大涨71.72%的原因。表2 全球阿尔茨海默症特殊评审通道盘点数据来源：药智数据未来布局展望新药屡败屡战，面临着这个深度未知的领域，企业怎么样才能找到下一个金矿？可以从以下几个方面入手：早期诊断和预防：可以致力于开发更准确的早期诊断方法，以便能够尽早干预和治疗阿尔茨海默病。此外，预防性措施也是一个重要的研究领域，包括生活方式改变、药物干预等，其中疫苗就是很关键的一个路径，而且目前在研管线不算多，还处于一片蓝海市场。理解病因和病理机制：努力深入了解阿尔茨海默病的病因和病理机制，这有助于揭示疾病的发展过程，并为新药物或新疫苗的研发提供目标。综合治疗方法：除了药物治疗外，综合治疗方法也被广泛研究，这包括认知训练、心理支持、康复治疗等，旨在提高患者的生活质量和功能能力。阿尔茨海默病这个“黑洞”，目前还没有找到完全治愈该疾病的方法。谁能够找到突破口，谁就能挖掘出第一桶“金”。声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 八角转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

疫苗临床3期临床结果突破性疗法临床2期

2022-11-30

·FierceBiotech

J&J unit, happy with AC Immune Alzheimer's work, moves 1 of 2 shots to next step

At the Clinical Trials on Alzheimer’s Disease conference, AC Immune compared ACI-35.030 to a different protein conjugate vaccine the companies are developing called JACI-35.054. As the pharma world chatters about the merits of the amyloid theory in Alzheimer’s disease, Johnson & Johnson is taking things in another direction. The healthcare giant’s pharmaceutical unit Janssen has picked a tau vaccine from its collaboration with neurodegenerative-focused biotech AC Immune to advance into further development. That means that another shot in development by the pair, JACI-35.054, will not move forward. The two vaccines had been tested head-to-head and ultimately, the candidate called ACI-35.030 was the winner, a spokesperson for AC Immune confirmed to Fierce Biotech. The decision comes as AC Immune presents interim phase 1b/2a data at the Clinical Trials on Alzheimer’s Disease (CTAD) conference showing that ACI-35.030 led to strong and durable induction of antibodies that target tau. The vaccine is designed to reduce the spread of the protein called tau, which misfolds and tangles up in the brains of patients with Alzheimer’s. AC Immune CEO Andrea Pfeifer, M.D., called the advancement “a significant step for this collaboration.” She noted that early clinical testing has shown ACI-35.030 was well tolerated. The average age of the trial participants was 65, meaning the vaccine could become a treatment and preventive measure against Alzheimer’s. While details are slim, the advancement means a completely new study for ACI-35.030 beyond the ongoing phase 1b/2a. The spokesperson could not provide additional details, only that AC Immune will no longer be responsible for material development costs. Under the original terms of the 2014 agreement, AC Immune and Janssen would work together through phase 1b, with Janssen taking the reins for phase 2 and beyond, including manufacturing and commercialization. At CTAD, AC Immune compared ACI-35.030 to the protein conjugate vaccine JACI-35.054. That shot is being tested in a parallel phase 1b/2 study. AC Immune will have three vaccines in phase 2 testing in 2023 and is working on other therapeutics and diagnostics for neurodegenerative diseases as well. The company also has partnerships with Eli Lilly and Roche’s Genentech unit. A number of leading Alzheimer’s drug developers are presenting at CTAD, including Eisai, which on Tuesday evening provided additional data on its phase 3, Biogen-partnered amyloid monoclonal antibody lecanemab. The Japanese pharma detailed two deaths that have made headlines over the past few months and also performed analysis of quality of life and caregiver data to make the case for the therapy. Both Lilly and Genentech are scheduled to present Wednesday, with many industry watchers awaiting more details on the Roche unit’s failed phase 3 study for gantenerumab. Editor's Note: This story was updated at 12:07 p.m. ET on Nov. 30, 2022, to include information on the discontinuation of JACI-35.054.

疫苗临床3期临床2期引进/卖出

100 项与 JACI-35.054 相关的药物交易

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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	临床2期	芬兰	Janssen Research & Development LLC	2019-07-31
阿尔茨海默症	临床2期	芬兰	AC Immune SA	2019-07-31
阿尔茨海默症	临床2期	荷兰	AC Immune SA	2019-07-31
阿尔茨海默症	临床2期	荷兰	Janssen Research & Development LLC	2019-07-31
阿尔茨海默症	临床2期	瑞典	Janssen Research & Development LLC	2019-07-31
阿尔茨海默症	临床2期	瑞典	AC Immune SA	2019-07-31
阿尔茨海默症	临床2期	英国	AC Immune SA	2019-07-31
阿尔茨海默症	临床2期	英国	Janssen Research & Development LLC	2019-07-31
轻度认知障碍	临床2期	芬兰	Janssen Research & Development LLC	2019-07-31
轻度认知障碍	临床2期	芬兰	AC Immune SA	2019-07-31

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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


NCT04445831 (EBioMedicine) 人工标引	临床1/2期	阿尔茨海默症	57	ACI‑35.030 (all doses (300/900/1800 µg))	選遞願廠憲夢積鹹憲繭(醖醖遞鬱齋壓膚獵夢窪) = ACI‑35.030: 100% responders after 1st injection; sustained 94–100% at high dose until wk74. JACI‑35.054: Heterogeneous; required ≥2 injections to reach 100% responders. Placebo: 4 pts from the pooled placebo group had anti-pTau IgG titres slightly above the responder threshold at sporadic timepoints due to some variability inherent to the assay. 窪淵襯積鹽廠遞遞獵簾 (襯蓋製蓋鬱廠構齋壓願 ) 更多	积极	2025-09-18
				JACI‑35.054 (all doses (15/60 µg))
NCT04445831 (CTgov)	临床1/2期	阿尔茨海默症 \| 认知功能障碍 \| 轻度认知障碍	57	ACI-35.030 (Sub-Cohort 1.1 (ACI-35.030 300 μg))	鹹築糧願繭憲觸淵製衊 = 廠獵齋窪齋醖餘願鹹蓋糧衊鹽艱夢簾觸繭網齋 (壓廠糧憲衊鬱膚製鹹鹹, 鹽製願繭簾鏇艱願蓋遞 ~ 簾糧顧餘壓觸願壓鬱蓋) 更多	-	2025-02-14
				ACI (Sub-Cohort 1.2 (ACI-35.030 900 μg))	鹹築糧願繭憲觸淵製衊 = 顧齋膚顧淵淵齋鑰膚繭糧衊鹽艱夢簾觸繭網齋 (壓廠糧憲衊鬱膚製鹹鹹, 積鹹鏇衊顧鑰膚餘構壓 ~ 築鬱餘醖憲憲餘繭膚廠) 更多