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首页> 外文期刊>EBioMedicine >Efficacy and Blood Plasmalogen Changes by Oral Administration of Plasmalogen in Patients with Mild Alzheimer's Disease and Mild Cognitive Impairment: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
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Efficacy and Blood Plasmalogen Changes by Oral Administration of Plasmalogen in Patients with Mild Alzheimer's Disease and Mild Cognitive Impairment: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

机译：轻度阿尔茨海默氏病和轻度认知障碍患者口服血浆生成素的疗效和血液中血浆血浆生成素的变化：多中心，随机，双盲，安慰剂对照试验

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Background: Plasmalogens (Pls) reportedly decreased in postmortem brain and in the blood of patients with Alzheimer's disease (AD). Recently we showed that intraperitoneal administration of Pls improved cognitive function in experimental animals. In the present trial, we tested the efficacy of oral administration of scallop-derived purified Pls with respect to cognitive function and blood Pls changes in patients with mild AD and mild cognitive impairment (MCI). Methods: The study was a multicenter, randomized, double-blind, placebo-controlled trial of 24weeks. Participants were 328 patients aged 60 to 85years who had 20 to 27 points in Mini Mental State Examination-Japanese (MMSE-J) score and five or less points in Geriatric Depression Scale-Short Version-Japanese (GDS-S-J). They were randomized to receive either 1mg/day of Pls purified from scallop or placebo. The patients and study physicians were masked to the assignment. The primary outcome was MMSE-J. The secondary outcomes included Wechsler Memory Scale-Revised (WMS-R), GDS-S-J and concentration of phosphatidyl ethanolamine plasmalogens (PlsPE) in erythrocyte membrane and plasma. This trial is registered with the University Hospital Medical Information Network, number UMIN000014945. Findings: Of 328 patients enrolled, 276 patients completed the trial (140 in the treatment group and 136 in the placebo group). In an intention-to-treat analysis including both mild AD (20@?MMSE-J@?23) and MCI (24@?MMSE-J@?27), no significant difference was shown between the treatment and placebo groups in the primary and secondary outcomes, with no severe adverse events in either group. In mild AD patients, WMS-R improved significantly in the treatment group, and the between group difference was nearly significant (P=0.067). In a subgroup analysis of mild AD patients, WMS-R significantly improved among females and those aged below 77years in the treatment group, and the between-group differences were statistically significant in females (P=0.017) and in those aged below 77years (P=0.029). Patients with mild AD showed a significantly greater decrease in plasma PlsPE in the placebo group than in the treatment group. Interpretation: Oral administration of scallop-derived purified Pls may improve cognitive functions of mild AD. Funding: The Japanese Plasmalogen Society.
机译：背景：据报道，阿尔茨海默氏病（AD）患者的死后大脑和血液中的血浆纤溶酶（Pls）减少。最近，我们显示腹膜内注射Pls可改善实验动物的认知功能。在本试验中，我们测试了轻度AD和轻度认知障碍（MCI）患者口服给药扇贝衍生的纯化Pls对认知功能和血液Pls变化的功效。方法：这项研究是一项为期24周的多中心，随机，双盲，安慰剂对照试验。参加者为328位年龄在60至85岁的患者，他们的日本迷你精神状态检查（MMSE-J）得分为20至27分，而老年抑郁量表-简版日语（GDS-S-J）得分为5分以下。他们被随机接受从扇贝或安慰剂中纯化的1mg /天的Pls。患者和研究医师均被掩盖。主要结果是MMSE-J。次要结果包括修订的Wechsler记忆量表（WMS-R），GDS-S-J以及红细胞膜和血浆中磷脂酰乙醇胺缩醛磷脂（PlsPE）的浓度。该试验已在大学医院医学信息网络中注册，编号为UMIN000014945。结果：在328名患者中，有276名患者完成了试验（治疗组140名，安慰剂组136名）。在包括轻度AD（20 @？MMSE-J @？23）和MCI（24 @？MMSE-J @？27）的意向治疗分析中，治疗组和安慰剂组之间没有显着差异。主要和次要结局，两组均无严重不良事件。在轻度AD患者中，治疗组的WMS-R显着改善，组间差异近乎显着（P = 0.067）。在轻度AD患者的亚组分析中，治疗组的女性和77岁以下的患者的WMS-R显着改善，女性之间的组间差异具有统计学意义（P = 0.017）; 77岁以下的患者之间的组间差异具有统计学意义（P = 0.029）。轻度AD患者在安慰剂组中血浆PlsPE的下降明显大于治疗组。解释：口服扇贝来源的纯化的Pl可能会改善轻度AD的认知功能。资金来源：日本疟原虫学会。

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