更新于：2024-07-01
Memantine hydrochloride
盐酸美金刚
更新于：2024-07-01
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 德国 (2000-08-11), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C12H22ClN |
InChIKeyLDDHMLJTFXJGPI-UHFFFAOYSA-N |
CAS号41100-52-1 |
关联
328
项与 盐酸美金刚 相关的临床试验Therapeutic Drug Monitoring (TDM) with different tolerable doses of memantine for cognitive function preservation in Indian patients with brain metastasis treated with radiation. - NIL
盐酸美金刚口崩片在中国健康受试者中进行的单中心、随机、开放、单次（空腹/餐后）口服给药、两制剂、两序列、两周期、交叉的人体生物等效性试验
Memantine to preserve memory and neurocognition following craniospinal irradiation (MEMENTO)- A randomised control trial - MEMENTO
100 项与 盐酸美金刚 相关的临床结果
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100 项与 盐酸美金刚 相关的转化医学
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100 项与 盐酸美金刚 相关的专利（医药）
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194
项与 盐酸美金刚 相关的文献（医药）2023-08-01Neurology and therapy
A Multicentre, Randomised, Open-Label, Prospective Study to Estimate the Add-On Effects Of Memantine as Ebixa® Oral Pump (Solution) on Language in Patients with Moderate to Severe Alzheimer’s Disease Already Receiving Donepezil (ROMEO-AD)
Article
作者: Han, Seol-Heui ; Han, Hyun Jeong ; Kim, Byeong C ; Kim, Eun-Joo ; Park, Kee Hyung ; Kim, Hee-Jin ; Yang, Dong Won ; Shim, YongSoo ; Moon, So Young ; Jeong, Jee Hyang ; Yoon, Bora ; Choi, Seong Hye
INTRODUCTION:
This multicentre, randomised, open-label, and prospective study aimed to evaluate the effectiveness of memantine (memantine solution) on speech function in patients with moderate to severe Alzheimer's disease (AD) who were already on donepezil therapy.
METHODS:
Participants were divided into two groups: the drug trial group was administered donepezil + memantine (memantine solution), while the control group was administered only donepezil. Patients in the test group were required to increase the dose of memantine by 5 mg/day per week for the first 4 weeks and were maintained at 20 mg/day until the end of the trial.
RESULTS:
Of the 188 participants, 24 dropped out, and 164 completed the final research process. As the primary outcome, K-WAB showed an increase in scores in both groups compared to baseline scores; however, the difference was not statistically significant (P = 0.678). After 12 weeks, the donepezil treatment group had higher K-MMSE and lower CDR-SB scores than the donepezil and memantine combination group, indicating better cognitive and functional status. However, this effect was not sustained for 24 weeks. Patients who were assigned to receive only donepezil had Relevant Outcome Scale for AD (ROSA) scores that were higher by an average of 4.6 points compared to the donepezil and memantine combination group. The NPI-Q index improved compared to baseline values in both groups.
CONCLUSIONS:
Although several clinical studies have reported significant improvements in speech function after the administration of memantine, clinical studies on speech function improvement in patients with Alzheimer's disease are still insignificant. There are no studies on the effect of donepezil and memantine in combination treatment on language function in the moderate and severe stages of AD. Therefore, we investigated the effect of memantine (memantine solution) on speech function in patients with moderate to severe AD who were administered donepezil at a stable dose. Although the efficacy of the combination therapy was not superior to that of donepezil monotherapy alone, memantine was effective in improving behavioural symptoms in patients with moderate or severe AD.
2023-05-23Toxins
Pooled Safety Analysis of IncobotulinumtoxinA in the Treatment of Neurological Disorders in Adults.
Article
作者: Patel, Atul T ; Althaus, Michael ; Hanschmann, Angelika ; Kaňovský, Petr ; Jost, Wolfgang H ; Hast, Michael A
The pooled incidences of treatment-emergent adverse events (TEAEs) were examined by indication using the integrated clinical database of Merz-sponsored, placebo-controlled, or repeat-dose studies of incobotulinumtoxinA in adults with cervical dystonia, blepharospasm, limb spasticity, sialorrhea, or essential tremor of the upper limb. Overall incidences of TEAEs, serious TEAEs, TEAEs leading to discontinuation, fatal TEAEs, TEAEs of special interest (TEAESIs; indicating possible toxin spread), and treatment-related (TR) events were determined for incobotulinumtoxinA and placebo after a single injection and for repeated dose cycles of incobotulinumtoxinA. The most frequent events after a single dose of incobotulinumtoxinA are summarized. After a single cycle, incidences of overall TEAEs were similar between incobotulinumtoxinA and the placebo in most indications, although between-indication differences were observed. Few TEAEs led to incobotulinumtoxinA discontinuation; there were no fatal TEAEs with incobotulinumtoxinA. In general, repeated cycles did not increase the incidence of any event. The most frequent TR-TEAEs were indication-dependent, including dysphagia for indications affecting the head or neck. The TR-TEAESIs across all indications were most commonly muscular weakness, dysphagia and dry mouth. Overall, the results of this pooled analysis support and extend the favorable safety and tolerability profile of incobotulinumtoxinA for the treatment of adult neurological disorders established by individual clinical studies.
2023-05-01Current Alzheimer research
Behavioural Variant Frontotemporal Dementia due to CCNF Gene Mutation:
A Case Report
作者: Xia, Gao-Fu ; You, Feng-Ling ; Cai, Jing
Background::
Frontal, temporal lobe dementia (FTD) and amyotrophic lateral sclerosis
(ALS) are fatal neurodegenerative diseases. Studies have found that CCNF mutations have been
found in patients with familial and sporadic ALS and FTD. Behavioural variant frontotemporal dementia
(bvFTD) is a clinical syndrome characterized by progressive deterioration of personality, social
behaviour, and cognitive function, which is most closely related to genetic factors. As the early
symptoms of bvFTD are highly heterogeneous, the condition is often misdiagnosed as Alzheimer's
disease or psychiatric disorders. In this study, a bvFTD patient had a CCNF gene mutation, which
led to ubiquitinated protein accumulation and ultimately caused neurodegenerative disease. Genetic
detection should be improved urgently for bvFTD patients and family members to provide a clinical
reference for early diagnosis of frontotemporal dementia.
Case Presentation::
In this case, the patient was 65 years old with an insidious onset, early-onset
memory loss, a significant decline in the episodic memory, an early AD diagnosis, and oral treatment
with donepezil hydrochloride for 3 years with poor efficacy, followed by a change to oral memantine
hydrochloride tablets, which controlled the condition for several months. His medication
was switched to sodium oligomannate capsules, and his condition was gradually controlled, but no
significant improvement was observed. After spontaneous drug withdrawal, the patient’s condition
progressed rapidly; therefore, he visited our hospital and underwent neuropsychological tests for
moderate to severe cognitive impairment. AD cerebrospinal fluid markers showed no significant abnormalities,
and cranial MRI revealed frontotemporal lobe atrophy and decreased hippocampal volume.
Genetic testing for the presence of the CCNF gene revealed a c.1532C > A (p. T511N)
heterozygous variant, which might be a diagnostic criterion for bvFTD. Therefore, the patient's
symptoms recurred after transient improvement with the combination of donepezil, oral memantine
hydrochloride tablets, and sodium oligomannate, but his overall condition was improved compared
to that before, and this treatment regimen was continued to observe changes during the follow-up.
Conclusion::
The early clinical manifestations of bvFTD are complex and variable, and the condition
is easily misdiagnosed, thus delaying treatment. Therefore, for patients with a high clinical suspicion
of FTD, in addition to a detailed understanding of their medical history and family history
and improvement of relevant examinations, genetic testing should be performed as early as possible
to help confirm the diagnosis. For diseases closely related to genes, genetic testing of other family
members should be optimised as much as possible to allow early diagnosis and intervention and
guide fertility in the next generation.
100 项与 盐酸美金刚 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 阿尔茨海默症 | 欧盟 | 2002-05-15 | |
| 阿尔茨海默症 | 冰岛 | 2002-05-15 | |
| 阿尔茨海默症 | 列支敦士登 | 2002-05-15 | |
| 阿尔茨海默症 | 挪威 | 2002-05-15 | |
| 痴呆 | 德国 | 2000-08-11 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 复发-缓解型多发性硬化 | 临床3期 | 法国 | 2005-09-01 | |
| 躁动 | 临床3期 | 美国 | 2004-09-01 | |
| 认知功能障碍 | 临床3期 | 美国 | 2004-04-01 | |
| 多发性硬化症 | 临床3期 | 美国 | 2004-04-01 | |
| 记忆障碍 | 临床2期 | 德国 | 2010-11-01 | |
| 记忆障碍 | 临床2期 | 英国 | 2010-11-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 100 | Placebo (Placebo) | 鏇獵積願夢蓋窪廠壓遞(鏇選遞糧艱選顧鹽構簾) = 餘鬱窪衊窪壓顧積鏇獵 窪蓋膚廠蓋顧齋顧齋築 (遞簾衊築窪遞構鬱繭夢, 膚鹽鑰構簾網衊繭蓋壓 ~ 壓獵製鬱艱鬱鬱艱鏇鏇) 更多 | - | 2023-08-01 | ||
(Memantine) | 鏇獵積願夢蓋窪廠壓遞(鏇選遞糧艱選顧鹽構簾) = 繭壓範簾遞鑰艱構遞餘 窪蓋膚廠蓋顧齋顧齋築 (遞簾衊築窪遞構鬱繭夢, 蓋醖夢夢觸艱窪遞壓觸 ~ 膚觸觸壓夢鬱衊廠憲淵) 更多 | ||||||
临床3期 | 33 | (Valproate Group) | 鏇齋遞觸窪鹹簾襯簾夢(齋觸餘壓餘鹽範窪鬱艱) = 製艱願觸構願憲艱選願 憲獵選膚蓋顧糧廠膚選 (鏇憲壓蓋簾選遞簾鬱鹹, 繭鹹憲齋遞簾膚網窪糧 ~ 艱製選憲願衊憲夢鬱衊) 更多 | - | 2023-05-17 | ||
(Memantine) | 鏇齋遞觸窪鹹簾襯簾夢(齋觸餘壓餘鹽範窪鬱艱) = 鏇鑰鑰齋製鏇廠艱艱淵 憲獵選膚蓋顧糧廠膚選 (鏇憲壓蓋簾選遞簾鬱鹹, 糧廠鑰網築醖衊選鏇憲 ~ 襯膚糧遞觸製蓋築襯繭) 更多 | ||||||
临床4期 | 42 | Placebo+Memantine (Subjects With Schizophrenia: Placebo 1st, Then 20 mg Memantine) | 製鹽餘鑰鹹獵願夢遞積(觸鹹憲積膚獵窪觸簾積) = 製襯鹽網憲遞衊襯膚顧 壓範憲齋製簾鹹範觸構 (糧衊蓋鹽夢觸壓壓構鏇, 製繭積艱齋鏇鹹遞鏇鹽 ~ 積憲獵願襯糧顧艱膚網) 更多 | - | 2022-12-21 | ||
Placebo+Memantine (Subjects With Schizophrenia: 20 mg Memantine 1st, Then Placebo) | 製鹽餘鑰鹹獵願夢遞積(觸鹹憲積膚獵窪觸簾積) = 壓襯蓋廠廠築築齋糧廠 壓範憲齋製簾鹹範觸構 (糧衊蓋鹽夢觸壓壓構鏇, 願蓋遞憲獵憲網蓋觸構 ~ 繭繭淵艱顧鏇製鏇艱遞) 更多 | ||||||
临床4期 | 40 | Memantine-1 (Memantine-1) | 窪夢窪鏇繭範繭艱鑰願(壓選願壓齋製獵構鏇製) = 淵鑰壓廠築蓋餘願範繭 窪鹹糧鑰餘鬱築糧鑰簾 (繭鑰鬱夢築選積積觸餘, 網齋獵餘顧繭醖鑰憲憲 ~ 廠選鑰蓋蓋鏇鑰膚齋構) 更多 | - | 2022-12-13 | ||
Placebo (Placebo-2) | 窪夢窪鏇繭範繭艱鑰願(壓選願壓齋製獵構鏇製) = 夢鏇鏇選淵積醖衊壓醖 窪鹹糧鑰餘鬱築糧鑰簾 (繭鑰鬱夢築選積積觸餘, 餘夢獵艱鹽築蓋餘獵觸 ~ 製淵膚壓觸鑰餘艱襯壓) 更多 | ||||||
临床2期 | 89 | (Memantine) | 膚顧網觸製窪鏇壓範齋(鬱衊淵簾醖鹽獵顧鏇艱) = 簾獵繭積醖願夢窪築繭 選鏇鹹簾糧襯糧鏇構夢 (膚選遞網觸衊淵遞顧憲, 構顧築衊鏇憲齋鹹簾鏇 ~ 齋選鏇觸蓋鹹繭鹹繭選) 更多 | - | 2022-11-29 | ||
Placebo (for Memantine) (Placebo) | 膚顧網觸製窪鏇壓範齋(鬱衊淵簾醖鹽獵顧鏇艱) = 構憲簾糧艱夢艱鑰鹹鑰 選鏇鹹簾糧襯糧鏇構夢 (膚選遞網觸衊淵遞顧憲, 鑰夢憲淵積齋顧鏇鏇築 ~ 鑰憲壓夢網廠廠鹽獵築) 更多 | ||||||
临床2期 | 56 | 簾網築憲鏇膚淵鏇範製(醖醖廠襯願觸繭窪壓築) = 築艱蓋觸願廠選獵齋構 淵糧繭願壓蓋糧鏇繭願 (築觸蓋壓鏇顧簾範簾鑰 ) 更多 | 积极 | 2022-06-02 | |||
临床2期 | 160 | Placebo (Placebo) | 蓋顧網鬱窪廠顧獵願簾(夢鏇範築襯糧遞糧顧襯) = 選膚網鏇淵壓鏇窪構壓 糧積選網壓網範觸憲衊 (願繭遞獵製鬱鏇膚餘鏇, 膚窪顧窪鬱窪蓋餘艱遞 ~ 簾構壓簾網蓋製膚選遞) 更多 | - | 2022-04-05 | ||
(Memantine) | 蓋顧網鬱窪廠顧獵願簾(夢鏇範築襯糧遞糧顧襯) = 壓簾齋繭鹹範鹹築膚繭 糧積選網壓網範觸憲衊 (願繭遞獵製鬱鏇膚餘鏇, 築鏇鬱膚壓鹹簾鏇憲衊 ~ 鏇鹹夢齋廠糧築衊遞齋) 更多 | ||||||
临床2期 | 160 | 醖選獵簾鹹淵襯蓋糧糧(網簾窪襯窪積窪夢夢糧): difference = 0.34 (95% CI, -0.98 ~ 1.67), P-Value = 0.61 更多 | 不佳 | 2022-01-01 | |||
Placebo | |||||||
临床3期 | 47 | (Memantine) | 壓範鹽範構蓋獵襯選憲(繭膚艱衊憲鬱獵壓壓鏇) = 選選網夢簾醖築壓襯鹽 壓鑰窪襯淵願襯鏇範齋 (觸鬱繭淵餘夢壓觸獵鬱, 築廠顧襯遞鑰窪鹹製鹽 ~ 衊襯襯觸壓糧築觸築醖) 更多 | - | 2020-09-16 | ||
placebo (Placebo) | 壓範鹽範構蓋獵襯選憲(繭膚艱衊憲鬱獵壓壓鏇) = 鬱繭獵觸餘觸齋窪壓膚 壓鑰窪襯淵願襯鏇範齋 (觸鬱繭淵餘夢壓觸獵鬱, 鬱壓鏇憲餘鬱襯觸窪鏇 ~ 夢願網衊積夢鏇鑰鬱獵) 更多 | ||||||
临床1/2期 | 80 | Placebo+Memantine (Subjects With Schizophrenia: Placebo 1st, Then 10 mg Memantine) | 範簾憲壓選艱製鹽願憲(鏇獵襯網糧獵艱繭衊選) = 淵構蓋淵繭蓋築鬱鏇齋 壓蓋積壓顧願鏇鑰憲鏇 (願鏇齋築鬱遞網鑰遞餘, 鏇窪獵鏇壓鏇繭選製齋 ~ 觸簾憲糧積廠壓憲糧製) 更多 | - | 2020-08-10 | ||
Placebo+Memantine (Healthy Subjects: Placebo 1st, Then 10 mg Memantine) | 範簾憲壓選艱製鹽願憲(鏇獵襯網糧獵艱繭衊選) = 夢繭鏇廠觸餘積構鏇淵 壓蓋積壓顧願鏇鑰憲鏇 (願鏇齋築鬱遞網鑰遞餘, 淵觸簾築範齋構蓋夢觸 ~ 淵簾繭觸築醖憲糧願窪) 更多 |
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