A two-part, randomized, two-period, two-sequence crossover and placebo-controlled parallel group, phase 1B trial to evaluate the safety and pharmacokinetics of Modafinil administered in combination with Aniracetam in elderly subjects with subjective cognitive decline - Safety of Modafinil & aniracetam in healthy elderly with cognitive decline

开始日期2019-09-13

申办/合作机构-

100 项与茴拉西坦相关的临床结果

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100 项与茴拉西坦相关的转化医学

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100 项与茴拉西坦相关的专利（医药）

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309

项与茴拉西坦相关的文献（医药）

2024-08-01·JOURNAL OF ORAL REHABILITATION

Effect of bolus property on swallowing dynamics in patients with dysphagia

Article

作者: Ita, Reiko ; Magara, Jin ; Inoue, Makoto ; Takei, Eri ; Suzuki, Taku ; Hino, Haruka ; Sasa, Anna ; Kulvanich, Sirima ; Tsujimura, Takanori ; Maekawa, Kazuya

Abstract:

Background:

Modification of foods or liquids is commonly administered as part of dysphagia treatment. However, no consensus exists on the parameters for defining texture‐modified food for patients with dysphagia.

Objectives:

The aim of this study was to evaluate the effect of food/liquid material on swallowing physiology in patients with dysphagia and to discuss the optimal food choice for direct swallowing therapy.

Materials and Methods:

A total of 140 patients underwent a videofluoroscopic swallowing study using three test foods/liquids: 3 mL of mildly thick liquid (Thick liquid), jelly made of agar and polysaccharide (Jelly) and jelly made of pectin (Reset gel). Outcome measures of videofluoroscopic images, bolus transit time and hyoid movements were compared.

Results:

The frequency of chewing movements was highest for Jelly, followed by Reset gel and Thick liquid. While the probability of oral residue was the highest for Reset gel, pharyngeal residue after swallowing was high for Thick liquid as compared to Jelly and Reset gel. Oral transit time and pharyngeal transit time for Thick liquid were significantly smaller than that for Jelly and Reset gel. Pharyngeal delay time was significantly smaller for Thick liquid than that for Jelly and Reset gel. There was no difference in hyoid elevation time and hyoid movement time among the conditions.

Conclusion:

Mildly thick liquid material may be optimal for patients with primarily oral motor function impairment and jelly, such as Reset gel, may be more suitable for patients with primarily pharyngeal motor function impairment or oral and pharyngeal coordinative motor function decline.

2024-04-16·Journal of Alzheimer's disease : JAD

Aniracetam: An Evidence-Based Model for Preventing the Accumulation of Amyloid-β Plaques in Alzheimer’s Disease

Article

作者: Love, Robert W.B.

Alzheimer’s disease is the leading cause of dementia in the world. It affects 6 million people in the United States and 50 million people worldwide. Alzheimer’s disease is characterized by the accumulation of amyloid-β plaques (Aβ), an increase in tau protein neurofibrillary tangles, and a loss of synapses. Since the 1990s, removing and reducing Aβ has been the focus of Alzheimer’s treatment and prevention research. The accumulation of Aβ can lead to oxidative stress, inflammation, neurotoxicity, and eventually apoptosis. These insults impair signaling systems in the brain, potentially leading to memory loss and cognitive decline. Aniracetam is a safe, effective, cognitive-enhancing drug that improves memory in both human and animal studies. Aniracetam may prevent the production and accumulation of Aβ by increasing α-secretase activity through two distinct pathways: 1) increasing brain derived neurotrophic factor expression and 2) positively modulating metabotropic glutamate receptors. This is the first paper to propose an evidence-based model for aniracetam reducing the accumulation and production of Aβ.

2023-12-01·Naunyn-Schmiedeberg's archives of pharmacology

AMPA receptor modulation through sequential treatment with perampanel and aniracetam mitigates post-stroke damage in experimental model of ischemic stroke

Article

作者: Sharma, Himanshu ; Sharma, Uma ; Reeta, K H ; Suri, Vaishali ; Singh, Surender

The present study evaluates the effect of modulating α-amino-3-hydroxy-5-methyl-4-isoxazole propionate receptor (AMPAR) by inhibiting them in the acute phase and activating them in the sub-acute phase on post-stroke recovery in middle cerebral artery occlusion (MCAo) model of stroke in rats. After 90 min of MCAo, perampanel (an AMPAR antagonist, 1.5 mg/kg i.p) and aniracetam (an AMPA agonist, 50 mg/kg i.p.) were administered for different durations after MCAo. Later, after obtaining the best time point for the antagonist and the agonist treatment protocols, sequential treatment with perampanel and aniracetam were given, and the effect on neurological damage and post stroke recovery were assessed. Perampanel and aniracetam significantly protected MCAo-induced neurological damage and diminished the infarct percentage. Furthermore, treatment with these study drugs improved the motor coordination and grip strength. Sequential treatment with perampanel and aniracetam reduced the infarct percentage as assessed by MRI. Moreover, these compounds diminished the inflammation via reducing the levels of pro-inflammatory cytokines (TNF-α, IL-1β) and increasing the levels of anti-inflammatory cytokine (IL-10) along with reductions in GFAP expression. Moreover, the neuroprotective markers (BDNF and TrkB) were found to be significantly increased. Levels of apoptotic markers (Bax, cleaved-caspase-3; Bcl2 and TUNEL positive cells) and neuronal damage (MAP-2) were normalized with the AMPA antagonist and agonist treatment. Expressions of GluR1 and GluR2 subunits of AMPAR were significantly enhanced with sequential treatment. The present study thus showed that modulation of AMPAR improves neurobehavioral deficits and reduces the infarct percentage through anti-inflammatory, neuroprotective and anti-apoptotic effects.

项与茴拉西坦相关的新闻（医药）

2024-03-18

·佰傲谷BioValley

数字疗法企业裁员、卖身

近日，美国的数字疗法企业Better Therapeutics宣布将缩减业务、裁员，并为公司剩余资产寻找买家。公司目前处于退市的边缘，但是上周公司董事会没有选择推出重新遵守股市交易规则的计划，而是要求其退市。此消息放出后，公司的股票当天暴跌80%。数字疗法于2010年在美国有了雏形，通过软件程序来向患者提供基于治疗措施或干预措施。据《2022年全球数字疗法产业报告》，2020年全球数字疗法市场规模已达35亿美元。Better成立于2015年，公司使用经临床验证的、FDA监管的软件来改变导致心脏代谢疾病的行为，以改善生活治疗，较少持续的药物需求，并降低成本。2021年，Better借助“数字疗法第一股”Pear Therapeutics上市的东风上市。但是成于此，败也此。2023年4月，Pear Therapeutics申请破产并关闭运营，Bette也将很快步其后尘。2021年12月，Pear以110亿人民币的价格登陆纳斯达克，被业内誉为“数字疗法第一股”。但是上市一年后，百一估值就化为泡影。在申请破产保护之前，Pear共有三款数字疗法产品获批上市，分别针对药物使用障碍（ReSET）、阿片类药物使用障碍（ReSET-O）和慢性失眠（Somryst）。2017年，Pear推出的首款数字疗法产品ReSET通过FDA审批，成为官方认证的“世界上第一款数字疗法”。但是上市后，就开始走下坡路。2022年度，Pear营业亏损为1.234亿美元，收入仅为1270万美元。股价也从9美元左右跌至不足2美元。截止申请破产前，Pear的股价从9美元跌至0.22美元，市值蒸发一百多亿。与Pear相比，Better的情况更加艰难，目前还没有上市的产品。Better目前的产品线包括4款产品——针对治疗2型糖尿病的BT-001、针对高血压的BT-002、针对高脂血症的BT-003和针对非酒精性脂肪肝的BT-004。目前只有BT-001管线处于关键性临床阶段，BT-002和BT-003仍在试点研究阶段，BT-004处于发现阶段。2023年7月，公司的AspyreRx项目获得FDA新的临床许可，为高血糖患者提供数字疗法，同时一项临床研究表明，该项目改善了患者的血压、体重和生活质量。此外，今年2月份，Better的另一项针对晚期肝病的数字疗法获得了FDA的突破性疗法认证。但是随着行业龙头Pear的前车之鉴，Better似乎也开始不被看好，关门卖身可能是迫不得已的选择。参考来源：1.https://www.fiercebiotech.com/medtech/digital-diabetes-app-maker-better-therapeutics-shutters-operations-lays-staff2.https://www.bettertx.com/pipeline/本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处·····

财报突破性疗法加速审批高管变更

2023-04-13

·生物制药小编

“数字疗法第一股”Pear Therapeutics申请破产

在宣布将开始寻找战略替代方案不到一个月后，数字疗法先驱Pear Therapeutics决定走项破产之路。根据该公司最近向美国证券交易委员会提交的文件中披露，包括首席执行官Corey McCann在内的几乎所有员工(总共170人，占92%)都将被解雇，剩下的15名员工在法院的监督下，负责进行公司资产的出售交易。Pear于2013年成立，是一家基于软件的数字疗法平台提供商，致力于处方数字疗法（PDT）的研发工作。Pear已经向市场成功推出了三种处方数字疗法。2017年，Pear推出的首款数字疗法ReSET通过FDA审批，成为官方认证的“世界上第一款数字疗法”。2018年，Pear推出其第二款数字疗法reSET-O，用于治疗阿片类药物使用障碍症。2020年推出用于治疗慢性失眠的数字疗法Somryst。此外，Pear旗下还有14个在研产品，覆盖精神病学、神经病学、胃肠、肿瘤学和心血管等多个领域。因为在数字疗法领域的领先地位，Pear成立之后备受资本青睐，先后完成8轮融资，获得了包括软银、淡马锡等知名风投机构的支持，2021年12月，Pear通过SPAC形式登陆纳斯达克，被业内誉为“数字疗法第一股”。而在闯过了艰难的监管关卡后，处方数字疗法面临的最大挑战则是商业规模化。一方面，数字疗法很像药品，有着较为严格的临床要求，需要有类似药品的功效才能获得市场的认可。但另一方面，处方类数字疗法的有效性受到医生投入的精力、病人的依从性和医疗制度本身的完善性等诸多因素的影响，任一环节的缺失，都会使得整个产品的疗效很难体现，最终无法说服用户继续使用。Corey McCann也表示很难让客户（保险公司）为其产品买单是导致Pear破产的关键原因。Pear在一份证监会的文件中提到，目前美国医疗保险并未把处方数字疗法涵盖在内。2022年，Pear的数字疗法产品开出了4.5万张处方，但只有约一半付费，而且公司仅能收取其中41%的费用。2022年度，Pear营业亏损1.234亿美元，收入仅为1270万美元。为了控制成本，去年Pear进行了两轮裁员，分别裁掉了25人和59人，以期节约超过1000万美元的成本。不过，两番裁员也没能让Pear摆脱困境，在2022年生物科技资本寒冬之下，数字疗法的艰难推广让公司也无力支撑下去，Pear的现金流已经宣告枯竭，截至2022年底，Pear的现金和现金等价物总计4830万美元。今年3月17日，Pear寻求战略性解决方案（strategic alternatives），包括潜在的合并、出售、资产剥离或者额外融资。而在申请破产保护前，Pear委托的的投资银行MTS Health Partners已经接触了140多家潜在买家，其中24家公司准备签署保密协议。不过，在评估所有选项后，Pear最终还是选择申请了破产保护。参考出处：https://www.sec.gov/ix?doc=/Archives/edgar/data/1835567/000183556723000018/pear-20221231.htmhttps://xueqiu.com/S/PEAR/247063450https://xueqiu.com/4171822787/244884657https://endpts.com/digital-therapeutics-maker-pear-files-for-bankruptcy-lays-off-170-staffers-including-ceo/

抗体药物偶联物财报生物类似药

2023-02-27

·BioSpace

Pear Therapeutics to Participate in 43rd Annual Cowen Healthcare Conference

BOSTON--(BUSINESS WIRE)-- Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced the Company will participate in the 43rd Annual Cowen Healthcare Conference being held March 6-8, 2023 in Boston. Corey McCann, M.D., Ph.D., President and CEO, will represent the Company in an analyst-led fireside chat on Monday, March 6 at 9:10 a.m. Eastern Time. A live audio webcast can be accessed by clicking here and will be made available in the Investors section of Pear’s website at . A replay of the webcast will be available on Pear’s website for up to 30 days following the live presentation. About Pear Therapeutics Pear Therapeutics, Inc., which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs). Pear aims to redefine care through the widespread use of clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst® for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at .

突破性疗法

100 项与茴拉西坦相关的药物交易

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