Pakdaman Hossein, Amini Harandi Ali, Abbasi Mehdi, Delavar Kasmaei Hosein, Ashrafi Farzad, Gharagozli Koroush, Assarzadegan Farhad, Behnam Behdad, Arabahmadi Mehran
Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Dement Geriatr Cogn Dis Extra. 2017 May 4;7(1):136-142. doi: 10.1159/000458521. eCollection 2017 Jan-Apr.
Mild cognitive impairment (MCI) is characterized by declined cognitive function greater than that expected for a person's age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients.
Seventy-two patients with a diagnosis of MCI were recruited. The included participants were randomly assigned to groups to receive either MLC601 or placebo. An evaluation of global cognitive function was performed at baseline as well as at 3-month and 6-month follow-up visits. Global cognitive function was assessed by Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) scores. Efficacy was evaluated by comparing global function scores between the 2 groups during the study period. Safety assessment included adverse events (AEs) and abnormal laboratory results.
Seventy patients completed the study, 34 in the MLC601 group and 36 in the placebo group. The mean changes (±SD) in cognition scores over 6 months in the MLC601 group were -2.26 (±3.42) for the MMSE and 3.82 (±6.16) for the ADAS-cog; in the placebo group, they were -2.66 (±3.43) for the MMSE and 4.41 (±6.66) for the ADAS-cog. The cognition changes based on both MMSE and ADAS-cog scores were statistically significant between the placebo and the MLC601 group ( < 0.001). Only 5 patients (14.7%) reported minor AEs in the MLC601 group, the most commonly reported of which were gastrointestinal, none of them leading to patient withdrawal.
MLC601 has shown promising efficacy and acceptable AEs in MCI patients.
轻度认知障碍（MCI）的特征是认知功能衰退程度超过同年龄人预期。这种状况的临床意义在于其可能进展为痴呆。MLC601是一种天然神经保护药物，已在阿尔茨海默病中显示出有前景的效果。因此，我们开展了这项随机、双盲、安慰剂对照研究，以评估MLC601对MCI患者的疗效和安全性。
招募了72例诊断为MCI的患者。纳入的参与者被随机分组，分别接受MLC601或安慰剂。在基线以及3个月和6个月随访时进行整体认知功能评估。通过简易精神状态检查表（MMSE）和阿尔茨海默病评估量表认知分量表（ADAS-cog）评分来评估整体认知功能。通过比较研究期间两组的整体功能评分来评估疗效。安全性评估包括不良事件（AE）和异常实验室检查结果。
70例患者完成了研究，MLC601组34例，安慰剂组36例。MLC601组6个月内认知评分的平均变化（±标准差）为，MMSE为-2.26（±3.42），ADAS-cog为3.82（±6.16）；安慰剂组中，MMSE为-2.66（±3.43），ADAS-cog为4.41（±6.66）。基于MMSE和ADAS-cog评分的认知变化在安慰剂组和MLC601组之间具有统计学意义（<0.001）。MLC601组只有5例患者（14.7%）报告了轻微不良事件，最常见的是胃肠道不良事件，均未导致患者退出研究。
MLC601在MCI患者中显示出有前景的疗效和可接受的不良事件。
