NeuroAid (MLC601、MLC901)治疗阿尔茨海默病患者的长期研究延长8年随访研究。

Q3 Medicine
Hossein Pakdaman, Ali Amini Harandi, Koroush Gharagozli, Fatemeh Siavoshi, Siavash Shirzadeh Barough, Ehsan Sharifipour, Akram Esfandani, Saba Ilkhani, Fatemeh Sadat Tabatabaei, Seyed Ali Sobhanian
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引用次数: 0

摘要

背景:MLC601和MLC901在治疗痴呆和认知障碍方面表现出神经保护和神经再生的特性和积极的结果。本研究旨在探讨MLC601和MLC901单药治疗阿尔茨海默病(AD)患者的长期获益。方法:本研究纳入符合DSM-IV诊断标准的AD患者。患者接受MLC601治疗4年,他们的治疗方案改为MLC901治疗4年。对招募的患者进行随访,首先评估MLC601和MLC901的有效性和安全性。采用简易精神状态检查(MMSE)和阿尔茨海默病评估量表-认知亚量表(ADAS-Cog)评估认知功能。通过监测不良事件(ae)和体检或实验室检查的异常结果来评估安全性。结果:试验结束时,MMSE和ADAS-Cog评分的平均值(±SD)变化分别为5.1(3.09)和12.5(10.89)。在重复测量分析中,两种评分都显示出显著变化,ADAS-Cog评分的变化高于MMSE评分(P < 0.001)。结论:八年多来,我们研究了NeuroAid (MLC601, MLC901)对AD患者的单药治疗。本研究进一步提供了MLC治疗AD患者的长期安全性和有效性数据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Long-term Study of NeuroAid (MLC601, MLC901) in Patients with Alzheimer's Disease; An Extension 8-year Follow-up Study.

Background: MLC601 and MLC901 showed neuroprotective and neuroregenerative properties and positive results in the treatment of dementia and cognitive impairment. This study aimed to investigate the long-term benefits of monotherapy with MLC601 and MLC901 in patients with Alzheimer's disease (AD).

Methods: In this study, patients with AD, diagnosed by DSM-IV criteria, were enrolled. Patients have received MLC601 for four years, and their regimen has changed to MLC901 for another four years. Recruited patients were followed to assess the efficacy and safety first of MLC601 and MLC901. Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) were used to assess cognitive function. Safety was evaluated by monitoring adverse events (AEs) and abnormal findings in physical examinations or lab tests.

Results: At the end of the trial, the changes in the mean (±SD) MMSE and ADAS-Cog scores were 5.1 (3.09) and 12.5 (10.89), respectively. Both scores showed a significant change in repeated measure analysis, with the ADAS-Cog score indicating a higher change than the MMSE score (P < 0.001).

Conclusion: For more than eight years, we studied monotherapy with NeuroAid (MLC601, MLC901) in patients with AD. The study contributes further to the long-term safety and efficacy data of MLC in patients with AD.

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来源期刊
Current aging science
Current aging science Medicine-Geriatrics and Gerontology
CiteScore
3.90
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