A Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 Over 52 Weeks in Participants with Early Alzheimer's Disease (Polaris-AD)

This AR1001-ADP3-US01 protocol is a double-blind, randomized, placebo-controlled, multi- center, parallel-group comparison pivotal Phase 3 study to evaluate the efficacy and safety of AR1001 for the treatment of participants with early AD.

开始日期2022-12-23

申办/合作机构

ARIBIO Co., Ltd.

NCT03625622

/ Completed临床2期

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease

A double-blinded, randomized, placebo-controlled study will be performed to evaluate the efficacy and safety of treating AR1001 in patients with mild to moderate Alzheimer's disease for 26 weeks.

开始日期2019-04-01

申办/合作机构

ARIBIO Co., Ltd.

100 项与 Mirodenafil dihydrochloride 相关的临床结果

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100 项与 Mirodenafil dihydrochloride 相关的转化医学

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100 项与 Mirodenafil dihydrochloride 相关的专利（医药）

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4,623

项与 Mirodenafil dihydrochloride 相关的文献（医药）

2025-06-01·SEPARATION AND PURIFICATION TECHNOLOGY

Energy-efficient CO2 capture using novel low-viscosity water-lean aromatic amine solvent MBA/BDMA/EG/H2O: Performance, mechanism and thermodynamics

作者: Chi, Shudan ; Li, Wenrui ; Yang, Linjun ; Yu, Hang ; Hou, Dawei ; Wang, Xin ; Jin, Lijian ; Hou, Xueyan ; Kong, Sining ; Yang, Hangqi

To address the challenges of high regeneration energy and corrosion in traditional mixed amine absorbents, as well as the increased viscosity issues in water-lean absorbents post-saturation, this study introduces the co-solvent ethylene glycol (EG) to replace part of the water in the high stability N-methylbenzylamine (MBA) and N, N-dimethylbenzylamine (BDMA) systems, resulting in a novel water-lean aromatic amine solvent, MBA/BDMA/EG/H₂O, is proposed as an alternative solutionThe addition of the tertiary amine BDMA significantly enhanced the regeneration efficiency of the absorbent.When the mass ratio of MBA/BDMA/EG/H₂O is set at 1.5:1.5:3.5:3.5, the CO₂ loading reaches 0.36 mol/mol, while the viscosity is only 10.82 mPa·s at room temperatureThe CO₂ capture mechanism of this absorbent was elucidated using ¹³C NMR and quantum chem. calculationsInitially, CO₂ reacts with MBA to form MBACOO^-/MBAH⁺.Subsequently, MBA⁺COO^- undergoes deprotonation to produce MBAH⁺ and BDMAH⁺.As the concentration of free MBA decreases to a certain level, BDMA undergoes hydrolysis, resulting in the formation of HCO^-₃.In the later stages of absorption, some of the carbamate products convert to unstable alkyl carbonates by reaction with EG.Notably, the regeneration energy of MBEH is reduced by 21.1% (estimate), compared to 30% MEA aqueous solutionThe corrosion rate of 30% MEA (after absorption) on carbon steel is 3.6 times higher than that of MBEH (after absorption).Therefore, the proposed MBEH solution presents a promising absorbent with excellent desorption performance, low viscosity, reduced regeneration energy, and low corrosion rate.

2025-05-01·JOURNAL OF CATALYSIS

Exhaustive reduction of aromatic esters and carboxylic acids with a homogeneous cobalt catalyst

作者: Zhang, Yan-Qiang ; Xu, Bao-Hua ; Lin, Jin-Qing ; Sun, Rui ; Zhang, Zi-Heng ; Jiang, Yuan-Yuan

A one-step procedure to exhaustively reduce aromatic esters and carboxylic acids to their corresponding tolyl derivatives is a significant transformation in organic synthesis, which remains challenging in homogeneous catalysis.In this study, it's achieved by using the well-defined phosphinesulfonate chelated cobalt-based catalyst (Co(dppbsa)), along with NaBAr^F₄ as the basic additive and (MeO)₂MeSiH as the reductant.Particularly, this cobalt catalysis proceeds through ether intermediates.Exptl. combined theor. results support it follows an outer-sphere ionic hydrosilylation mechanism and the in situ formed cationic siloxane species are involved in the rate-limiting hydride transfer.The same system also enables the catalytic deoxygenation of aliphatic esters, aliphatic acids, and amides but terminating at the corresponding ethers, alkanols and secondary amines, resp.These findings open up novel avenues for the catalytic application of phosphinesulfonate chelated complexes, potentially serving as the foundation for the exhaustive reduction of carboxylic skeletons with cobalt.

2025-05-01·JOURNAL OF HAZARDOUS MATERIALS

Degradation of N-methylbenzylamine and N,N-dimethylbenzylamine in anaerobic biological reactors and formation of N-nitrosomethylbenzylamine and N-nitrosodimethylamine during subsequent chloramination

Article

作者: Chen, Guan-Fu ; Peng, Shih-Wen ; Premarathne, Iresha ; Tseng, Yu-Chun ; Su, Yu-Jih ; Chen, Wei-Hsiang

As water reuse demand increases, wastewater treatment plants must manage byproducts effectively while ensuring safety. The excessive use of benzalkonium chloride disinfectants can lead to the accumulation of benzylamines, such as N-methylbenzylamine (MBA) and N,N-dimethylbenzylamine (DMBA). Biological anaerobic treatment is becoming more popular due to concerns over energy consumption and carbon emissions. Our study examined the biodegradation of MBA and DMBA during anaerobic treatment and their effects on toxic byproduct formation during subsequent chloramination, as well as their impact on bioreactor performance, degradation pathways, and microbial communities. Our results showed that anaerobic bioreactors had minimal impact on overall treatment performance despite the presence of MBA and DMBA. MBA proved resistant to biodegradation, whereas DMBA underwent significant biodegradation. Notably, during chloramination, MBA effluent formed nitroso-MBA with a 1 % molar yield, whereas DMBA effluent had significant N-nitrosodimethylamine formation, with molar yields reaching 10 ± 1 % and 97 ± 7 % of the influent and residual DMBA concentrations. We observed significant differences in microbial communities between the DMBA reactor and the MBA and control reactors. Proposed degradation pathways and the involvement of specific microbial communities were detailed. These findings highlight the importance of thoroughly evaluating biologically treated effluent to manage the risks of toxic byproducts in water reuse.

项与 Mirodenafil dihydrochloride 相关的新闻（医药）

2024-12-31

·vbdata

纽科智联：旗下拟治疗阿尔茨海默病在研药物AR1001国际多中心III期临床研究近日完成中国首例患者入组

纽科智联（上海）制药有限公司（以下简称“纽科智联”）近日宣布，公司与韩国AriBio CO.，Ltd（AriBio）在中国共同发起的“一项评价AR1001治疗早期阿尔茨海默病受试者持续52周的有效性和安全性的III期、双盲、随机、安慰剂对照、多中心试验”，已于2024年12月19日完成首例患者首次给药。首都医科大学宣武医院常务副院长、神经内科唐毅教授为该试验全球联合主要研究者，首都医科大学宣武医院作为中国的组长单位，中国近三十家医院参加本研究。 AR1001是一种治疗早期阿尔茨海默病的候选药物，具有强效、高选择性抑制磷酸二酯酶-5（PDE-5）的作用。临床前研究显示AR001可清除AD相关的淀粉样斑块、抑制Tau蛋白的异常磷酸化，同时抑制炎症反应，并提供神经保护作用。此前经美国FDA（食品药品监督管理局）批准在美国完成的临床II期研究结果显示，AR1001口服片剂（30mg）具有良好的安全性特征，有望为早期AD人群（包括AD引起的轻度认知功能障碍和轻度痴呆）提供治疗获益。目前，除中国外，AR1001在美国、英国、欧盟、韩国等多地开展多中心临床III期研究，拟入组1150名患者，目前全球已完成入组人数过半。作为该试验全球联合主要研究者之一的唐毅教授表示，“AD是一种多致病因素的老年疾病。近年来，随着诊断技术和病理研究的迅速发展，AD的治疗领域也迎来了新的曙光。AR1001作为一款安全性优良的口服多机制小分子药物，有望为AD的治疗提供全新的思路和方向，期待其临床效果能尽快得到验证，早日满足人口老龄化带来的日益增长的临床需求，尽早服务广大AD患者。”

临床3期临床2期

2024-12-27

·医学新视点

宣武医院唐毅教授共同领衔阿尔茨海默病新药国际研究，首例中国患者完成入组

▎药明康德内容团队编辑阿尔茨海默病（AD）是当今世界上主要的神经退行性疾病之一，约占所有痴呆病例的60%~80%。据《中国阿尔茨海默病报告2024》数据显示，中国现存的AD及其他痴呆患病人数近1700万。目前全球已上市的AD治疗药物多为对症治疗，近年来获批的靶向β淀粉样蛋白病理的创新药能够减缓认知功能下降、延缓疾病进展，但仍有一些局限。随着老龄人口的逐渐增多，以及AD患病率随年龄增长而增加，迫切需要更多能够预防和延缓AD进展的治疗方法。近年来，随着科学界对AD机理认知加深和对不同药物靶点的多元研究的开展，人们对于AD药物的开发进入全新阶段，研究人员致力于通过更多样化的机制和路径，寻找更有效的AD治疗方案。据公开资料，截至2024年12月，全球范围内预计近20款AD药物正处于临床3期的关键开发阶段。研发焦点除了专注对症治疗AD的药物外，也逐渐转向能够缓解疾病发展进程，以期为患者提供更全面的治疗效果。近日，韩国AriBio CO.,Ltd（AriBio）公司和纽科智联（上海）制药有限公司共同宣布，由双方在中国共同发起的一项评价AR1001治疗早期AD临床试验，已于2024年12月19日完成中国首例患者首次给药。首都医科大学宣武医院常务副院长、神经内科唐毅教授为该试验全球联合主要研究者，首都医科大学宣武医院作为中国的组长单位，中国近三十家医院参加本研究。目前，该关键注册临床研究在美国、英国、欧洲、中国和韩国等全球多个国家开展。 AR1001已获美国FDA批准开展临床研究，是用于延缓AD疾病进程的小分子口服药物，具有强效、高选择性抑制磷酸二酯酶-5（PDE-5）的作用。AR1001具有良好的安全性特征和血脑屏障透过性。临床前研究显示，AR1001可以清除AD相关的淀粉样斑块并抑制Tau蛋白的异常磷酸化，同时抑制炎性反应，并提供神经保护作用。在美国完成的2期AD临床研究结果显示，AR1001口服片剂（30 mg）具有良好的安全性特征，有望为早期AD人群（包括AD引起的轻度认知功能障碍和轻度痴呆）提供治疗获益。本次试验是一项3期、双盲、随机、安慰剂对照、多中心试验，评价AR1001治疗早期阿尔茨海默病受试者持续52周的有效性和安全性，计划入组1150名患者，跨越全球近200个研究中心。截止目前，AR1001在全球3期入组已完成过半。唐毅教授介绍道：“AD是一种多致病因素的老年疾病。近年来，随着诊断技术和病理研究的迅速发展，AD的治疗领域也迎来了新的曙光。AR1001作为一款安全性优良的口服多机制小分子药物，有望为AD治疗提供全新的思路和方向，期待其临床效果能尽快得到验证，早日满足人口老龄化带来的日益增长的临床需求，尽早服务广大AD患者。” 推荐阅读阿尔茨海默病风险降低41%！揭秘新型降糖药与精神疾病的关系 | EASD 2024 权威解读！2024年阿尔茨海默病诊断标准更新，3大核心问题值得关注《自然-医学》：治疗阿尔茨海默病新策略，逆转神经元损害，6个月就有改变做好这8件事，让大脑更健康！《自然-医学》综述：阿尔茨海默病研究最新进展提前18年发现阿尔茨海默病？宣武医院贾建平团队：这些指标有助于早诊早治欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。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。分享，点赞，在看，传递医学新知

临床2期临床3期申请上市临床成功

2024-10-15

·PRNewswire

Neurophet-AriBio to develop 'Next-Gen Platform for Alzheimer's diagnosis'

- Neurophet's brain MRI analysis technology incorporates fluid biomarker data from AriBio's global Phase 3 clinical trial for Alzheimer's disease - Collaborates leveraging Neurophet's medical image analysis technology and AriBio's clinical trial data analysis expertise SEOUL, South Korea, Oct. 15, 2024 /PRNewswire/ -- Neurophet, an artificial intelligence (AI) solution company for brain disease, announced its collaboration with AriBio, a biopharmaceutical company developing therapies for neurodegenerative diseases, to develop next-generation platform for Alzheimer's diagnosis. Continue Reading Neurophet-AriBio to develop ‘Next-Gen Platform for Alzheimer's diagnosis’ The collaboration aims to develop a new Alzheimer's diagnostic platform by integrating Neurophet's brain image analysis technology using MRI (magnetic resonance imaging) with fluid biomarker data from AriBio's global Phase 3 clinical trial for early Alzheimer's disease. AriBio's platform team with clinical trial data analytics capabilities will collaborate with Neurophet's AI team on developing this advanced diagnostic platform. The conventional method to diagnosing Alzheimer's disease typically involves amyloid-PET (positron emission tomography) scan or CSF (cerebrospinal fluid) test to detect cortical amyloid beta deposition and confirm the presence of Alzheimer's. However, amyloid-PET scans are relatively expensive, and the CSF test involves a lumbar puncture, where a long needle is inserted between the vertebrae to drain fluid, which causes pain and requires time for recovery. These limitations result in lower medical accessibility for patients. To address these challenges, Neurophet and AriBio are developing a new diagnostic platform. The plan is to create a platform that can predict the risk of amyloid beta protein positivity early by conducting MRI analysis and blood-based biomarker tests before amyloid-PET scans. This approach aims to reduce unnecessary amyloid-PET scans and actively utilize a more accessible Alzheimer's disease testing method. "By participating in AriBio's global Phase 3 clinical trial of AR1001, a broad range of medical data will be obtained to achieve meaningful research outcomes in various fields." said Jake Junkil Been, CEO of Neurophet. "If this platform is successfully developed, it could significantly reduce medical costs associated with dementia diagnosis and treatment, while also improving patient convenience." Jai Jun Choung, CEO of AriBio stated, "AriBio is working on a safe and easy-to-take oral tablet to ensure accessibility and convenience for Alzheimer's disease patients and their families, and we hope to further enhance diagnostic accessibility through our collaboration with Neurophet." Neurophet has entered into an agreement with AriBio to participate in the global phase 3 clinical trial of AR1001, an oral treatment for Alzheimer's disease. Neurophet plays a key role in identifying eligible patients for the trial and assessing the treatment effect of AR1001 using its brain imaging analysis technology. In addition, the two companies are conducting joint research and business development by utilizing the medical image, blood, and CSF data obtained from the large-scale, multinational AR1001 clinical trials. About Neurophet Neurophet has specialized in developing solutions for diagnosis support, treatment guides, and treatment devices targeting brain diseases based on cutting-edge artificial intelligence (AI) technology. The company was founded in 2016 by Jake Junkil Been, CEO, and Donghyeon Kim, CTO, who developed the next-generation neuro-navigation system. Major products include brain MRI analysis software "Neurophet AQUA", brain PET image analysis (PET tracer deposition) software "Neurophet SCALE PET", brain imaging treatment planning software for electric and magnetic brain stimulation "Neurophet tES/TMS LAB". Neurophet has set its top priority to helping patients suffering from brain diseases. Based on expertise in neuroscience, Neurophet will continue to challenge and grow to explore the human brain's health and pioneer solutions for brain diseases with AI technology. SOURCE Neurophet WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期

100 项与 Mirodenafil dihydrochloride 相关的药物交易

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研发状态

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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3期	美国	ARIBIO Co., Ltd.	2022-12-23
阿尔茨海默症	临床3期	中国	ARIBIO Co., Ltd.	2022-12-23
阿尔茨海默症	临床3期	捷克	ARIBIO Co., Ltd.	2022-12-23
阿尔茨海默症	临床3期	丹麦	ARIBIO Co., Ltd.	2022-12-23
阿尔茨海默症	临床3期	法国	ARIBIO Co., Ltd.	2022-12-23
阿尔茨海默症	临床3期	德国	ARIBIO Co., Ltd.	2022-12-23
阿尔茨海默症	临床3期	意大利	ARIBIO Co., Ltd.	2022-12-23
阿尔茨海默症	临床3期	荷兰	ARIBIO Co., Ltd.	2022-12-23
阿尔茨海默症	临床3期	波兰	ARIBIO Co., Ltd.	2022-12-23
阿尔茨海默症	临床3期	西班牙	ARIBIO Co., Ltd.	2022-12-23

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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


NCT03625622 (BusinessWire) 人工标引	临床2期	阿尔茨海默症	210	AR1001 10 mg	願範夢製壓製製繭壓艱(構衊觸範繭鏇齋鬱繭鹽) = 蓋夢艱獵顧鏇鏇膚鹽遞襯製糧構憲鏇網鹽鹹鹽 (鏇獵衊範餘獵築願鑰齋 )	积极	2021-11-04
				AR1001 30 mg	願網獵簾獵鬱蓋蓋繭齋(觸襯鹽醖簾積鹹艱鹽築) = 築繭糧糧襯願鏇糧鬱蓋選膚鑰範鏇獵醖積願遞 (選構遞壓繭廠築夢餘鑰 ) 更多