Evaluation of efficacy of add on oral amantadine in children and adolescents with subacute sclerosing panencephalitis aged less than 18years: A randomized controlled trial - nil

开始日期2025-05-21

申办/合作机构

All India Institute of Medical Sciences

NCT06817200

/ Not yet recruiting临床2期IIT

The Effect of Amantadine As Add-on Therapy for Motor Fluctuations in Advanced Parkinson's Disease: a Randomized Double-blinded Placebo-controlled Trial

Motor fluctuations are identified as the most challenging symptoms by parkinson disease patients. A recent post-hoc analysis of ADS-5012 trials (new formulation of ER Amantadine), revealed a significant improvement in OFF-time. No randomized clinical trial has ever specifically investigated to date the effect of amantadine IR on motor fluctuations. The main objective of this study is to evaluate the effect of amantadine (300 mg/day) as add-on therapy for the treatment of motor fluctuations (Off-time) in advanced Parkinson's disease patients versus placebo after 3 months of treatment.

开始日期2025-05-01

申办/合作机构

Toulouse University Hospital

NCT06234462

/ Recruiting临床2期IIT

Feasibility Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid: A Pilot Randomized Control Trial

Purpose: To decrease symptom burden, improve cognitive function, improve endurance, and decrease fatigue in subjects with post-acute sequelae of COVID-19 (PASC) or "long-hauler" COVID using amantadine. If amantadine use is determined to be efficacious in this population, the findings of this study will be used towards a subsequent randomized control trial.

开始日期2025-03-31

申办/合作机构

The University of Texas Southwestern Medical Center

100 项与盐酸金刚烷胺相关的临床结果

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100 项与盐酸金刚烷胺相关的转化医学

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100 项与盐酸金刚烷胺相关的专利（医药）

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9,952

项与盐酸金刚烷胺相关的文献（医药）

2025-10-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Cocrystallization of amantadine hydrochloride with nutrient: Insights into directed self- assembly and optimized biopharmaceutical character by integrating theory and experiment

Article

作者: Wu, Zhi-Yong ; Li, Yan-Tuan ; Zhao, Ming-Yu ; Wang, Ling-Yang ; Bu, Fan-Zhi

In order to make full use of the advantages of phenolic acid nutraceutical p-coumaric acid (COA) in cocrystallizing with antiviral medication amantadine hydrochloride (ADH), further get innovative insights into assembling ADH-nutraceutical cocrystal and optimizing biopharmaceutical characters of ADH by combining experiment with theory, a novel cocrystal, ADH-COA, is prepared and structurally characterized. Single-crystal X-ray diffraction confirms that the cocrystal consists of COA and ADH molecules in a 1:2 ratio, building a three-dimensional supramolecular network strengthened by charge-assisted hydrogen bonds and tightly packed patterns, which is distinguished by two distinct conformations H-1 and H-2 arising from neutral COA molecules with different counter-ions of ADH within the lattice. These features endow the cocrystal with promoting charge dispersion and polarity reduction, resulting in 37.11 ∼ 41.39 % solubility reduction under different pH conditions versus raw ADH, contributing to mitigating side effects associated with excessive solubility of ADH. Such change of in vitro property, in turn, optimizes in vivo pharmacokinetics, showcasing the lengthened half-life and enhanced 1.45-fold bioavailability. Emphatically, these experimental findings are corroborated by DFT-based theoretical models, demonstrating some positive correlations between macroscopic properties and microstructures of the cocrystal. Thereby, the dual-optimization of in vivo/vitro properties of ADH allows to be fulfilled through the cocrystallization-driven strategy.

2025-08-01·TALANTA

A novel one-step immunoassay using mesoporous core-shell Pd@Pt nanoparticles as an alternative to horseradish peroxidase for amantadine detection

Article

作者: Jiang, Haiyang ; Qin, Linqian ; Zhang, Shuai ; Zhang, Jiangjiang ; Sun, Boyan ; Xiong, Jincheng

The inherent limitations of natural enzymes hinder their stable application under harsh conditions, highlighting the urgent need for a stable alternative signal tracer. Herein, core-shell palladium@platinum (Pd@Pt) nanoparticles (NPs) with mesoporous and dendritic nanostructures were synthesized using a modified ultrasound-assisted chemical reduction method, resulting in a 25 % improvement in relative activity compared to previously reported methods. The yielding nanoparticles exhibited enhanced peroxidase-like activity with specific activity of 54.4 U/mg, and their Michaelis constant and maximum reaction velocity were 6.2 and 48 timers higher, respectively, than those of horseradish peroxidase (HRP). The Pd@Pt NPs were conjugated with antibodies via electrostatic adsorption, demonstrating their potential as a viable alternative to HRP. The rough surface structure of the Pd@Pt NPs not only enhanced the efficiency of antibody immobilization to approximately 90 %, but also, through a pH-regulated antibody immobilization strategy, facilitated the orientation of antibody recognition regions, thereby improving inhibition efficiency. A one-step immunoassay based on the Pd@Pt NPs immunoprobe was then developed, with amantadine (AMD) serving as a proof of concept. The proposed method showed a 2.8-fold increase in sensitivity, a 400-fold expansion in the linear range, and a 1-h reduction in detection time compared to the traditional "gold standard" ELISA. The practical applicability of the proposed method was validated in real chicken and pork samples, with coefficients of variation all less than 17.49 %, and a strong correlation with commercial kits was observed. These results suggest that Pd@Pt NPs are a promising signal-generating probe with significant potential as an alternative to HRP, offering improvements in sensitivity, linear range, stability, and other key performance characteristics.

2025-07-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Disorders of consciousness and pharmacotherapy: A systematic update on drugs inducing consciousness improvement

Review

作者: Cardile, Davide ; Ciurleo, Rosella ; Calabrò, Rocco Salvatore ; Bonanno, Lilla

BACKGROUND:

Disorders of consciousness (DOC) represent some of the least comprehended and challenging conditions within contemporary neurology. Pharmacological interventions are capable of enhancing neurotransmitter levels, synaptic plasticity and functional connectivity within consciousness networks.

OBJECTIVE:

This systematic work aims to provide a comprehensive 10-year update regarding the use of drugs that may induce consciousness improvement in patients with DOC.

METHODS:

A review of current literature was performed for articles published between 2014 and 2023. A study was excluded if there was a lack of data or information about pharmacological treatment in patients with DOC.

RESULTS:

12 studies with a total amount of 429 patients were identified as eligible for this paper. From our data review, 2 studies with 34 patients were identified on Baclofen. The latter was identified as the most effective treatment with an 82.35 % efficacy rate. On the other hand, 2 studies with 53 patients were identified for Amantadine that also show a substantial effectiveness of 68.42 %. Zolpidem was the most widely used medication as it was employed in 6 studies with 289 patients. Nevertheless, its efficacy showed high variability among individuals resulting in a comparatively lower average efficacy rate of 18.42 %. Finally, Opioids were evaluated in two studies with 53 patients showing an efficacy of 44 %. Within this category, the effectiveness of Propofol remained inconclusive due to the lack of specific improvement data. Overall, Baclofen and Amantadine emerged as the most effective treatments for improving conditions in patients with Disorders of Consciousness DoC.

CONCLUSIONS:

Over the last 10 years, amantadine and baclofen have proven to be the most promising treatments in terms of efficacy.

105

项与盐酸金刚烷胺相关的新闻（医药）

2025-04-22

·PRNewswire

XADAGO/EQUFINA Set to Revolutionize Parkinson's Disease Treatment Landscape | DelveInsight

As a selective monoamine oxidase B (MAO-B) inhibitor, XADAGO offers a unique mechanism of action that complements traditional therapies, potentially improving motor function and reducing "off" time in patients. The increasing prevalence of Parkinson's disease and the growing demand for effective therapies create a substantial market opportunity for XADAGO, particularly in regions with aging populations. LAS VEGAS, April 22, 2025 /PRNewswire/ -- DelveInsight's " XADAGO/EQUFINA Market Size, Forecast, and Market Insight Report" highlights the details around XADAGO/EQUFINA, an inhibitor of monoamine oxidase B (MAO-B) indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of XADAGO/EQUFINA. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Newron Pharmaceuticals/Eisai/Meiji Seika Pharma's XADAGO/EQUFINA (safinamide) Overview XADAGO is a monoamine oxidase B (MAO-B) inhibitor used alongside levodopa/carbidopa to help manage "off" episodes in individuals with Parkinson's disease. While its exact mode of action in treating Parkinson's is not fully understood, it is thought to work by inhibiting MAO-B, thereby reducing dopamine breakdown. This leads to increased dopamine levels and enhanced dopaminergic activity in the brain. XADAGO contains the active ingredient safinamide in the form of a mesylate salt and is available in 50 mg and 100 mg film-coated oral tablets. Each tablet provides either 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg of the safinamide base. The medication is marketed as XADAGO in the United States and Europe and under the name EQUFINA in Japan. Learn more about XADAGO/EQUFINA projected market size for Parkinson's disease @ XADAGO/EQUFINA Market Potential Parkinson's disease is a progressive neurological disorder that mainly impairs movement control. It results from the slow degeneration of dopamine-producing neurons in the brain, especially in the substantia nigra, a region crucial for managing voluntary motor function. According to estimates by DelveInsight, there were 2.7 million diagnosed prevalent cases of Parkinson's disease in the 7MM in 2023, with the United States accounting for around 45% of these cases. While a cure for Parkinson's remains elusive, a combination of pharmacological and non-pharmacological therapies is used to manage symptoms. Physical, occupational, and speech therapies form key components of treatment, and surgical procedures may benefit select patients. Additionally, complementary therapies are sometimes employed to help address particular symptoms. Frequently prescribed medications for Parkinson's include levodopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors, amantadine, anticholinergics, and adenosine A2A antagonists. These treatments primarily target motor symptoms, which are a major concern for those affected. DelveInsight reports that the Parkinson's disease market in the 7MM was valued at USD 3.2 billion in 2023. The market is expected to grow over the forecast period (2020–2034), fueled by the launch of new therapies, increasing prevalence, better access to healthcare, and rising demand for more advanced and effective treatment options. Discover more about the Parkinson's disease market in detail @ Parkinson's Disease Market Report Emerging Competitors of XADAGO/EQUFINA Some of the drugs in the pipeline include Solengepras (Cerevance), Minzasolmin (UCB Biopharma SRL/Novartis), Buntanetap (Annovis Bio), and others. Buntanetap has successfully completed Phase III trials for early-stage Parkinson's disease. Annovis Bio has scheduled a meeting with the FDA in Q1 2025 to determine the development path forward for Buntanetap in the treatment of Parkinson's disease. Buntanetap is also being developed for Alzheimer's disease, Lewy Body Dementia, and other neurodegenerative disorders. In November 2024, Cerevance announced the dosing of the first patient in its pivotal Phase III ARISE trial, evaluating solengepras as a potential adjunctive treatment for Parkinson's disease. Cerevance expects to report topline data in the first half of 2026. In December 2021, UCB partnered with Novartis to globally co-develop and co-commercialize UCB0599, a pioneering alpha-synuclein misfolding inhibitor currently in Phase II clinical trials for Parkinson's disease. To know more about the number of competing drugs in development, visit @ XADAGO/EQUFINA Market Positioning Compared to Other Drugs Key Milestones of XADAGO/EQUFINA In April 2020, Newron Pharmaceutical acknowledged that US WorldMeds, who held the US commercialization rights for the licensed drug, XADAGO, as a sub licensee of Zambon, had entered into a definitive agreement with Supernus Pharmaceuticals under which Supernus would acquire the CNS portfolio of US WorldMeds, including the US rights to XADAGO In November 2019, Eisai announced that it had launched the EQUFINA 50mg tablets for the indication of improvement of the wearing-off phenomenon in patients with Parkinson's disease under treatment with a drug containing levodopa in Japan. Manufacturing and marketing approval of EQUFINA was obtained in September 2019. In April 2017, Eisai Co., Ltd. and Meiji Seika Pharma announced entering into a license agreement for the commercialization of safinamide (development code: ME2125) to treat Parkinson's disease in Japan and Asia. In March 2017, Newron Pharmaceuticals announced the US FDA approval of XADAGO to treat Parkinson's disease as an add-on therapy to levodopa/carbidopa for patients experiencing "off" episodes. In March 2016, Zambon announced a strategic agreement with US WorldMeds to commercialize Newron's lead compound, XADAGO, to treat Parkinson's disease in the US. In February 2015, XADAGO was approved in the European Union as an add-on therapy to levodopa, alone or in combination with other Parkinson's medications, in mid-late stage PD patients with motor fluctuations. XADAGO/EQUFINA Patent Details XADAGO tablets are currently protected by three XADAGO patents with US patent numbers 8,076,515, 8,278,485, and 8,283,380, which expire between June 2027 and December 2028 and are listed in the FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. The company has a license agreement with Zambon S.p.A., Newron's partner, related to the XADAGO Patents, and as a new chemical entity, XADAGO is under the 5-year FDA exclusivity period that expires on March 21, 2022. In May 2017, Zambon filed a worldwide patent under the patent number WO2017207587A1. The invention relates to pharmaceutical compositions comprising safinamide and, more particularly, to taste-masked particles comprising said active ingredient or pharmaceutically acceptable salts thereof, oral dosage forms that include said particles, and a process for preparing them. Discover how XADAGO/EQUFINA is shaping the Parkinson's disease treatment landscape @ XADAGO 50mg XADAGO/EQUFINA Market Dynamics XADAGO, marketed as EQUFINA in some regions (notably in South Korea and Japan), is a once-daily oral selective MAO-B inhibitor used as an add-on treatment for Parkinson's disease patients experiencing "off" episodes while on a stable dose of levodopa. The drug's unique dual mechanism of action—MAO-B inhibition and modulation of glutamate release—offers both dopaminergic and non-dopaminergic effects, positioning it as a differentiated product in the PD adjunctive therapy landscape. This has helped it carve a niche in markets where patients are inadequately controlled by levodopa alone, particularly those in mid-to-late-stage PD. The global market dynamics for XADAGO/EQUFINA are shaped by a mix of competitive intensity, regional adoption trends, and payer dynamics. In the U.S. and Europe, the drug has faced stiff competition from generic MAO-B inhibitors (like selegiline and rasagiline) and newer Parkinson's disease therapies, including COMT inhibitors, dopamine agonists, and extended-release levodopa formulations. Despite this, its favorable safety profile and once-daily dosing have supported its uptake in certain patient segments, especially in Europe. Market penetration has been slower in the U.S. due to both reimbursement hurdles and physician preference for more established adjunctive treatments. In Asia, particularly Japan and South Korea, EQUFINA has demonstrated stronger market performance thanks to focused commercial strategies and a high unmet need for effective "off time" management. Meiji Seika Pharma and Eisai, the regional marketing partners, have successfully leveraged the drug's differentiated profile in clinician education, which has led to growing adoption among neurologists. In Japan, where the aging population is rapidly expanding and Parkinson's prevalence is rising, EQUFINA has benefited from both demographic tailwinds and formulary access. Looking ahead, the market outlook for XADAGO/EQUFINA depends on several strategic levers, including lifecycle management, regional partnerships, and real-world evidence generation. The manufacturer's ability to expand into new geographies, secure favorable reimbursement, and differentiate against both generics and newer entrants will be critical. Moreover, as Parkinson's disease treatment moves toward more personalized approaches, XADAGO/EQUFINA may find sustained relevance in specific subpopulations, particularly those requiring a balance of efficacy and tolerability. Dive deeper to get more insight into XADAGO/EQUFINA's strengths & weaknesses relative to competitors @ XADAGO/EQUFINA Market Drug Report Table of Contents Related Reports Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, Inc., Britannia Pharmaceutical, Pharma Two B, Mitsubishi Tanabe Pharma (NeuroDerm), AbbVie, Cerevel Therapeutics, Cerevance, among others. Parkinson's Disease Pipeline Parkinson's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Parkinson's disease companies, including Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., among others. Cell and Gene Therapy in Parkinson's Disease Market Cell and Gene Therapy in Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cell and gene therapy in Parkinson's disease companies including MeiraGTx, Hope Biosciences, Sumitomo Pharma, Prevail Therapeutics, BlueRock Therapeutics, Voyager Therapeutics, among others. Parkinson's Disease Psychosis Market Parkinson's Disease Psychosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease psychosis companies, including Sumitomo Pharma America Inc., Vanda Pharmaceuticals, Acadia Pharmaceuticals Inc., Otsuka America Pharmaceutical, Lundbeck LLC, Jazz Pharmaceuticals, Alkahest Inc., Sandoz, Sio Gene Therapies, Axovant Sciences Ltd, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP 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期上市批准引进/卖出临床2期

2025-03-29

·赞Med

第14届东方神经病学会议速递｜帕金森病的综合管理-药物篇

点击上方“蓝字”关注我们吧！为推动医疗事业发展，使国内从事神经病学专业的工作者了解国内外神经病学医学领域基础研究和临床实践的最新动态，提高我国神经疾病研究和防治工作水平，上海市医学会与上海市医学会神经内科分会、上海市医学会脑电图与神经生理专科分会悉心举办了第十四届东方神经病学会议，于2025年3月28日在上海隆重开幕，并在3月30日落下帷幕。此次学术盛会汇聚了各方智慧，为该领域注入崭新的活力与希望。 3月29日下午，复旦大学附属华山医院王坚教授、复旦大学附属中山医院金莉蓉教授，以「帕金森病的综合治疗-药物篇」为主题，对帕金森病的疾病负担，基于循证探索帕金森病药物治疗的进展以及可提供综合获益的药物新选择三方面进行了精彩的阐述和深入的分析。金教授展示了一项最新的帕金森病的流行病学研究,研究提示2050年全球预计将有2520万人患有帕金森病，比2021年增加112%; 患病率预计为267 / 10万，较2021年显著增加76%; 而年龄标准化患病率预计为216 / 10万,较2021年增加55%。在全球疾病负担区域中，其中东亚(1090万)预计病例数量最多1。此外，据最新公布的2021年GBD数据，全球帕金森病平均年龄标准化患病率为138.6/10万；其中中国帕金森病患者数为507.71万，新增患者数50.84万2，也就意味着我国帕金森病患者的疾病负担严重。同时金教授指出随着疾病进展，帕金森病患者会面临运动症状、非运动症状及并发症多重症状，一项纳入3206例帕金森病患者的国际大型、多中心、横断面研究提示相较于运动功能(MDS-UPDRS III)，非运动症状(MDS-UPDRS I)对生活质量的影响可能更显著，其中抑郁情绪、淡漠、疼痛和疲劳影响较大3。此外，症状波动也严重影响患者的生活质量，其中非运动症状的波动不容忽视，其中疼痛和情绪障碍是常见的波动的非运动症状4，提醒我们在对帕金森病患者进行管理时应对帕金森病的运动症状和非运动症状需采取全面综合治疗。随后，金教授分享了现有的治疗推荐以及目前基于循证探索帕金森病药物治疗的进展，包含了运动症状及并发症以及非运动症状的药物治疗推荐以及疗效证据更新。1运动症状领域在运动症状领域5，MAO-B抑制剂: 沙非胺进一步证实对运动波动临床有效。非麦角类多巴胺激动剂: 舌下阿扑吗啡是PD患者“关期”治疗的有效选择，但口咽部的副作用会影响耐受性; 罗匹尼罗贴片与罗匹尼罗片剂相比具有非劣效性。复方左旋多巴: 吸入性左旋多巴已被证明对PD的“关期”发作有效; 经皮左旋多巴输注有较好的疗效数据，但存在长期耐受性的问题; 常规补充维生素B12和叶酸可能预防与长期使用左旋多巴相关的同型半胱氨酸水平升高。COMT抑制剂: 奥匹卡朋在治疗运动波动中有效。腺苷A2A拮抗剂: preladenant（Merck, Rahway, NJ, USA）作为单药治疗无效。金刚烷胺: 金刚烷胺缓释剂可以减少异动症并改善“关期”时间。此外，2025年3月8号发布的运动波动MDS循证建议6提示常用的添加药物中左旋多巴中的IPX066（缓释剂），多巴胺激动剂中的普拉克索速释片及缓释片、罗匹尼罗速释片以及罗替高汀，COMT抑制剂中的奥匹卡朋，MAO-B抑制剂+通道阻滞剂（沙非胺）以及手术中的双侧STN-DBS在改善运动波动中表现为有效。2非运动症状领域而在非运动症状领域5，MAO-B抑制剂的疗效证据较多：一项纳入了司来吉兰、雷沙吉兰、沙非胺的荟萃分析显示整体对抑郁有效；一项RCT显示雷沙吉兰可改善睡眠质量；观察性研究及小型试点研究显示司来吉兰、雷沙吉兰可能有助于改善日间过度嗜睡；一项为期3个月的随机交叉试点研究显示沙非胺可改善RBD；随机对照研究的事后分析显示沙非胺可缓解帕金森病症状波动患者的疼痛。此外其他抗帕金森病药物证据包括非麦角类多巴胺激动剂: 对普拉克索和罗替高汀的荟萃分析显示对抑郁有效；一项荟萃分析显示罗替高汀可改善睡眠质量；一项RCT显示阿扑吗啡输注可改善入睡困难。最后，金教授分享了最近在中国上市的可提供综合获益的新药甲磺酸沙非胺，并逐一介绍了沙非胺的药理机制、国内外的临床试验数据以及欧洲共识等。确切地证实了甲磺酸沙非胺高度契合帕金森病患者的全面综合治疗需求。1药理机制沙非胺是一款同时具有多巴胺能机制和非多巴胺能机制的药物，其作为高度选择性、可逆的B型单胺氧化酶抑制剂，能有效减少已分泌多巴胺在突触间隙的降解，帮助维持大脑中的多巴胺浓度。除此之外，沙非胺还能阻断神经元上电压依赖性钠离子通道，从而抑制谷氨酸的过度释放。2国际临床试验在中国上市前，沙非胺在国外已积累了许多临床获益的证据。在国际多中心Ⅲ期研究中，沙非胺可显著增加“开”期时间，减少每日“关”期及清晨“关”期时间，减少“开”期状态下的UPDRS Ⅲ评分及PDQ-39评分7，8；在此基础上，其事后分析显示，沙非胺还可以减少合并有疼痛的帕金森病患者止痛药物使用频次9，改善帕金森病患者情绪障碍10和睡眠障碍11，12，并且以上提及的这些临床获益可长期维持。3国内临床试验在国内临床试验中，金教授着重介绍了沙非胺的中国Ⅲ期临床试验（XINDI研究）的关键结果，该结果也已于2022年发表在《CNS Drugs》上。此项研究显示沙非胺作为左旋多巴的联合治疗16周后，相比于安慰剂，可明显减少“关”期时间1.1小时（p <0.0001）。除了改善症状波动之外，此项研究中还显示，联用沙非胺之后可进一步减少“开”期状态下的UPDRS Ⅲ评分和PDQ-39评分，改善患者的运动症状和生活质量13。最后，金教授介绍了沙非胺在国外真实临床实践中的长期有效性和耐受性，尤其是和抗抑郁药物联用方面，并分享了沙非胺治疗帕金森病的欧洲共识。学术专场总结本次学术专题会的最后，会议主持王坚教授发言总结，帕金森病中晚期患者会合并各种症状波动，病情复杂，疾病负担较重。帕金森领域迫切需要新的药物出现，而甲磺酸沙非胺作为刚在中国上市的新药，其在症状波动、运动症状的改善，以及疼痛、情绪、睡眠等在内的非运动症状的控制均有不错的效果。我们相信沙非胺会给患者带来新的曙光。参考文献1.Su D, Cui Y, He C, et al. Projections for prevalence of Parkinson's disease and its driving factors in 195 countries and territories to 2050: modelling study of Global Burden of Disease Study 2021. BMJ. 2025 Mar 5;388:e0809522.Xu T, Dong W, Liu J, et al. Disease burden of Parkinson's disease in China and its provinces from 1990 to 2021: findings from the global burden of disease study 2021. Lancet Reg Health West Pac. 2024;46:101078.3. Skorvanek M, Martinez-Martin P, Kovacs N, et al. Relationship between the MDS-UPDRS and Quality of Life: A large multicenter study of 3206 patients. Parkinsonism Relat Disord. 2018;52:83-89.4. Chen W, Xiao Q, Shao M, et al. Prevalence of wearing-off and dyskinesia among the patients with Parkinson's disease on levodopa therapy: a multi-center registry survey in China. Transl Neurodegener. 2014 Dec 5;3(1):26. 5.Foltynie T, Bruno V, Fox S, et al. Medical, surgical, and physical treatments for Parkinson's disease. Lancet. 2024 Jan 20;403(10423):305-324. 6.de Bie RMA, Katzenschlager R, Swinnen BEKS, et al. Update on Treatments for Parkinson's Disease Motor Fluctuations - An International Parkinson and Movement Disorder Society Evidence-Based Medicine Review. Mov Disord. 2025 Mar 8. 7. Borgohain R, Szasz J, Stanzione P, et al. Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations. Mov Disord. 2014;29(2):229-237.8.Borgohain R, Szasz J, Stanzione P, et al. Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease. Mov Disord. 2014;29(10):1273-1280.9. Cattaneo C, Barone P, Bonizzoni E, et al. Effects of Safinamide on Pain in Fluctuating Parkinson's Disease Patients: A Post-Hoc Analysis. J Parkinsons Dis. 2017;7(1):95-101.10. Cattaneo C, Müller T, Bonizzoni E, et al. Long-Term Effects of Safinamide on Mood Fluctuations in Parkinson's Disease. J Parkinsons Dis. 2017;7(4):629-634.11.Santos García D, Cabo López I, Labandeira Guerra C, et al. Safinamide improves sleep and daytime sleepiness in Parkinson's disease: results from the SAFINONMOTOR study. Neurol Sci. 2022;43(4):2537-2544.12. Bovenzi R, Conti M, Pierantozzi M,et al. Safinamide effect on sleep architecture of motor fluctuating Parkinson's disease patients: A polysomnographic rasagiline-controlled study. Parkinsonism Relat Disord. 2024 Aug 13:127:107103.13.Wei Q, Tan Y, Xu P, et al. The XINDI Study: A Randomized Phase III Clinical Trial Evaluating the Efficacy and Safety of Safinamide as Add-On Therapy to Levodopa in Chinese Patients with Parkinson's Disease with Motor Fluctuations. CNS Drugs. 2022;36(11):1217-1227.提示：本材料仅供医疗卫生专业人士进行医学科学交流，不用于推广目的。

2025-03-23

·奇点网

《JAMA·精神病学》：揭示精神疾病的蛋白质密码！科学家发现血液中91种蛋白质的水平与精神分裂症、躁郁症和重度抑郁症等有关

*仅供医学专业人士阅读参考研究精神疾病的生物学机制，因为采样（大脑组织）困难，研究进展并不十分乐观。虽然可以利用外周循环蛋白等便于采样的样本进行研究，但是过去的研究往往通量较低，且容易受到环境因素干扰。全基因组关联研究（GWAS）有助于在大规模样本中发现与精神疾病相关的遗传因素，并深入揭示疾病机制。孟德尔随机化（MR）可以利用基因的随机分配来探索因果关系，避免环境因素的干扰。来自美国范斯坦医学研究所的研究团队，开展了迄今为止最大规模的双样本MR研究，讨论了对神经精神表型存在潜在因果影响蛋白质谱。研究利用英国生物样本库和deCODE Genetics的血液蛋白质组学数据，共鉴定了91种与精神分裂症（SCZ）、双相情感障碍（BD）和重度抑郁症（MDD）和认知任务表现（CTP）高度相关的蛋白质。药物靶向富集分析显示，抗炎药物对于SCZ、金刚烷胺对于BD、视黄酸对于MDD可能具有治疗效果。研究发表在《JAMA·精神病学》杂志上。研究数据来自英国生物样本库药物蛋白质组学项目（UKB-PPP）和deCODE Genetics，分别包括34557名英国个体的2923种蛋白质，以及35559名冰岛个体的4719种蛋白质，对蛋白质通路、蛋白质-蛋白质相互作用（PPI）、基因-药物相互作用、药物靶向性、药物靶点富集等进行分析。使用顺式蛋白质数量性状位点（cis-pQTLs）进行MR分析，鉴定出77种蛋白质可能与精神疾病易感性和CTP存在因果关联，其中SCZ 47种，BD 17种，MDD 7种，CTP 19种。 40%的蛋白质仅依赖单一的遗传变异位点与4种表型形成因果关系，多敏感性分析证实了结果的稳健性。UKB-PPP和deCODE队列使用了不同的蛋白质分析平台（Olink和SomaScan），结果具有中等一致性。使用Trans-pQTL（与蛋白质表达相关的远距离遗传变异）进行MR分析，鉴定出14种可能与精神疾病易感性和CTP存在因果关系的蛋白质，其中SCZ 6种，BD 3种，MDD 1种，CTP 7种。系统回顾发现，除了CTP相关的SYT17蛋白外，其余蛋白质均未被报道过。PI16蛋白在SCZ中表现出广泛的多效性，提示其遗传变异可能通过多条独立的生物途径影响SCZ及其他相关疾病。ITIH4和TWF2蛋白在4种表型中均存在因果关系。 4种表型相关蛋白质汇总许多蛋白质与免疫或炎症功能有关。SCZ的遗传风险与C反应蛋白（CRP）水平降低有关。IL23R是发现的最强的单一信号，水平升高与MDD风险增加和CTP恶化有关。在新发现的精神疾病相关蛋白质中，载脂蛋白B受体表现出与CTP强相关；PCMT1表现出神经保护作用；叶酸水解酶I（FOLH1）与BD风险增加有关。通路富集分析显示，SCZ相关蛋白富集于免疫反应、阿尔茨海默病、帕金森病等神经退行性疾病通路，BD相关蛋白富集于血小板相关肌肽酶介导的蛋白水解通路，MDD相关蛋白富集于神经发育、免疫功能及神经可塑性（MAPK信号通路）相关通路，CTP相关蛋白富集于轴突导向和轴突生成等神经发育和突触功能通路。 SCZ、BD、MDD和CTP相关的蛋白质表达调控位点药物靶点富集分析显示，发现的多种蛋白质已经是现有药物的靶点。SCZ相关蛋白富集于钙通道阻滞剂和烟碱型乙酰胆碱受体（nAChR）靶点，BD相关蛋白与抗精神病药物、情绪稳定剂（如奥氮平、卡马西平、丙戊酸钠）、以及抗NMDA受体药物（金刚烷胺）有关，MDD相关蛋白NEGR1和TYRO3是选择性血清素再摄取抑制剂（如帕罗西汀）和单胺氧化酶抑制剂（如苯乙肼）的靶点，CTP相关蛋白富集于具有促智和抗焦虑作用的药物的靶点。一些已获批药物可能对SCZ、BD和MDD具有治疗效果，比如抗炎药物对于SCZ、金刚烷胺对于BD、视黄酸对于MDD。总的来说，研究共发现了涉及SCZ、BD、MDD和CTP的91种蛋白质，与以往关于外周蛋白质水平或基因表达的研究相比，约一半的关联为首次发现。炎症标志物可能作为早期风险指标，用于预测精神疾病的发生风险。参考文献： Bhattacharyya U, John J, Lam M, et al. Circulating Blood-Based Proteins in Psychopathology and Cognition: A Mendelian Randomization Study. JAMA Psychiatry. Published online March 12, 2025. doi:10.1001/jamapsychiatry.2025.0033 本文作者丨王雪宁

基因疗法信使RNA临床结果临床研究

100 项与盐酸金刚烷胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00777	盐酸金刚烷胺	N04BB01	DB00915

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
药物引起的锥体外系副作用	美国	Supernus Pharmaceuticals, Inc.	2018-02-16
帕金森障碍	美国	Supernus Pharmaceuticals, Inc.	2017-08-24
甲型流感病毒感染	日本	Sun Pharma Japan Ltd.	1998-11-27
脑梗塞	日本	Sun Pharma Japan Ltd.	1987-10-02
流感病毒感染	中国	国药集团中联药业有限公司	1981-01-01
帕金森病	日本	Sun Pharma Japan Ltd.	1975-04-15

未上市

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
行走困难	临床3期	美国	Adamas Pharmaceuticals LLC	2018-03-29
行走困难	临床3期	加拿大	Adamas Pharmaceuticals LLC	2018-03-29
多发性硬化症	临床3期	美国	Adamas Pharmaceuticals LLC	2018-03-29
多发性硬化症	临床3期	加拿大	Adamas Pharmaceuticals LLC	2018-03-29
药物性运动障碍	临床3期	美国	Adamas Pharmaceuticals LLC	2014-07-30
药物性运动障碍	临床3期	加拿大	Adamas Pharmaceuticals LLC	2014-07-30
药物性运动障碍	临床3期	法国	Adamas Pharmaceuticals LLC	2014-07-30
药物性运动障碍	临床3期	德国	Adamas Pharmaceuticals LLC	2014-07-30
药物性运动障碍	临床3期	西班牙	Adamas Pharmaceuticals LLC	2014-07-30

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临床结果

适应症

分期

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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


NCT04387773 (CTgov)	临床4期	帕金森病	8	GOCOVRI	廠衊網繭膚築齋積製選(蓋鬱淵網鏇選鏇願壓選) = 鹽網蓋鏇鬱蓋醖獵鏇糧鏇網製製淵顧膚簾壓選 (壓襯鑰觸衊憲襯觸顧鑰, 6.23) 更多	-	2024-10-10
NS-Park cohort (MDS2023)	N/A	帕金森病	-	Amantadine	壓範鹹壓餘憲選顧糧淵(醖遞願遞憲簾積壓築糧) = 遞網窪淵憲簾願鹽繭膚窪艱淵蓋積蓋鏇夢鑰願 (積鏇鬱壓憲襯鑰願選壓 )	积极	2023-08-27
MDS2023	N/A	帕金森病	53	Responders to amantadine	襯製構襯範襯鹽壓艱簾(願膚選蓋願鏇簾壓製鹹) = 選淵獵憲選獵窪鹹顧積築憲簾艱鹹蓋淵獵積範 (鏇遞膚壓廠憲遞壓夢蓋 )	-	2023-08-27
MDS2023	N/A	帕金森病	53	Nonresponders to amantadine	襯製構襯範襯鹽壓艱簾(願膚選蓋願鏇簾壓製鹹) = 鹹獵顧壓鏇願襯壓繭簾築憲簾艱鹹蓋淵獵積範 (鏇遞膚壓廠憲遞壓夢蓋 )	-	2023-08-27
NCT04952519 (Pubmed \| Respir Med)	临床3期	新型冠状病毒感染	193	Amantadine	製蓋齋醖淵顧膚製壓憲(廠願艱壓觸鹽艱鬱構蓋) = 鏇觸願鑰繭範膚糧蓋鹹衊夢衊淵願鑰憲醖膚願 (積遞醖窪襯廠糧簾範繭, 9 ~ 11)	不佳	2023-03-15
NCT04952519 (Pubmed \| Respir Med)	临床3期	新型冠状病毒感染	193	Placebo	製蓋齋醖淵顧膚製壓憲(廠願艱壓觸鹽艱鬱構蓋) = 簾鬱餘網網醖範製願蓋衊夢衊淵願鑰憲醖膚願 (積遞醖窪襯廠糧簾範繭, 8 ~ 11)	不佳	2023-03-15
MDS2022	临床3期	运动失调	-	AMT DR/ER	壓願餘齋鹹齋網膚淵鹹(憲醖築壓願繭鹽積醖蓋) = 繭鏇積積簾願鹽鬱蓋選鏇築簾壓構壓廠淵蓋範 (壓範廠襯選獵選蓋選遞 ) 更多	-	2022-09-15
MDS2022	临床3期	运动失调	-	Placebo	壓願餘齋鹹齋網膚淵鹹(憲醖築壓願繭鹽積醖蓋) = 醖糧鬱窪顧願窪鬱範壓鏇築簾壓構壓廠淵蓋範 (壓範廠襯選獵選蓋選遞 ) 更多	-	2022-09-15
EAN2022	N/A	新型冠状病毒感染 \| 帕金森病	-	Amantadine	鹹繭醖簾廠鏇築鹹製窪(顧醖網蓋糧窪網糧獵蓋) = 顧糧夢醖遞鬱餘廠憲觸鏇廠齋鑰範蓋獵襯廠繭 (鬱餘餘淵鹽餘膚廠醖膚, 3)	-	2022-06-24
NCT04273737 (CTgov)	临床4期	认知功能障碍 \| 脑瘫	11	Amantadine Hydrochloride	網鑰衊廠鹽構遞鑰積窪(觸築鬱觸觸廠鹽選廠齋) = 壓鑰繭積繭壓衊繭繭鑰鑰憲鬱鹽醖願糧範構獵 (艱範構醖選簾鹽糧糧廠, 8.050) 更多	-	2022-05-31
P16-9.007 (AAN2022)	N/A	小脑疾病	12	Amantadine	鏇蓋艱積遞襯願遞壓繭(廠顧範艱蓋願廠遞襯餘) = Constipation was the most common side effect 窪齋衊窪選獵製襯積鏇 (製鹽窪鏇網淵築構鑰構 )	积极	2022-05-03
NCT03567057 (CTgov)	临床3期	多发性硬化症 \| 行走困难	424	Placebo+ADS-5102 (Placebo/274 mg ADS-5102)	鏇繭觸製繭構蓋網衊膚 = 願願鹹鏇願鏇壓範鹹窪積積鬱簾膚網遞鹹壓構 (壓積積窪鹹憲淵製網膚, 網築獵齋壓窪願構窪製 ~ 願製鬱齋襯憲觸窪衊構) 更多	-	2022-01-18
NCT03567057 (CTgov)	临床3期	多发性硬化症 \| 行走困难	424	ADS-5102 (137 mg ADS-5102/274 mg ADS-5102)	鏇繭觸製繭構蓋網衊膚 = 築築糧廠餘醖餘壓獵衊積積鬱簾膚網遞鹹壓構 (壓積積窪鹹憲淵製網膚, 鏇積齋夢簾鹽壓糧積衊 ~ 鬱簾壓壓壓構壓淵鹹鏇) 更多	-	2022-01-18
NCT03436199 (CTgov)	临床3期	多发性硬化症 \| 行走困难	558	Placebo	鹹夢餘窪鑰糧繭壓積醖 = 憲廠遞網糧獵鬱顧糧艱夢醖壓網壓鬱壓鹹醖蓋 (鬱網醖膚蓋簾願壓製鹹, 鏇範醖艱齋鏇選夢憲鹹 ~ 選艱壓壓壓壓觸淵鑰壓) 更多	-	2021-12-21