Research Center and Memory Clinic, Fundació ACE, Institut Català de Neurociències Aplicades-Universitat Internacional de Catalunya, Barcelona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas (CIBERNED), Instituto de Salud Carlos III, Madrid, Spain.
Alzheimers Dement. 2022 Jul;18(7):1314-1324. doi: 10.1002/alz.12477. Epub 2021 Nov 2.
We report the effects of plasma exchange (PE) with albumin replacement on neuropsychological, neuropsychiatric, and quality-of-life (QoL) outcomes in mild-to-moderate Alzheimer's disease (AD) patients in a phase 2b/3 trial (Alzheimer's Management by Albumin Replacement [AMBAR] study).
Three hundred forty-seven patients were randomized into placebo (sham-PE) and three PE-treatment arms with low/high doses of albumin, with/without intravenous immunoglobulin (IVIG). Specific test measurements were performed at baseline; month 2 (weekly conventional PE); months 6, 9, and 12 (monthly low-volume PE [LVPE]); and month 14.
The PE-treated mild-AD cohort improved their language fluency and processing speed versus placebo at month 14 (effect sizes: >100%; P-values: .03 to .001). The moderate-AD cohort significantly improved short-term verbal memory (effect sizes: 94% to >100%; P-values: .02 to .003). The progression of the neuropsychiatric symptoms of PE-treated was similar to placebo. Mild-AD patients showed improved QoL (P-values: .04 to .008).
PE-treated AD patients showed improvement in memory, language abilities, processing speed, and QoL-AD. No worsening of their psychoaffective status was observed.
我们报告了在轻度至中度阿尔茨海默病(AD)患者的 2b/3 期试验(白蛋白替代治疗阿尔茨海默病管理[AMBAR]研究)中,用白蛋白替代物进行血浆置换(PE)对神经心理学、神经精神和生活质量(QoL)结果的影响。
347 名患者被随机分为安慰剂(假 PE)和 3 个 PE 治疗组,分别接受低/高剂量白蛋白、有/无静脉注射免疫球蛋白(IVIG)治疗。在基线时、第 2 个月(每周常规 PE)、第 6、9 和 12 个月(每月低容量 PE [LVPE])以及第 14 个月进行特定的测试测量。
与安慰剂相比,PE 治疗的轻度 AD 队列在第 14 个月时提高了语言流畅性和处理速度(效应大小:>100%;P 值:.03 至.001)。中度 AD 队列的短期语言记忆显著改善(效应大小:94%至>100%;P 值:.02 至.003)。PE 治疗的神经精神症状进展与安慰剂相似。轻度 AD 患者的 QoL 得到改善(P 值:.04 至.008)。
PE 治疗的 AD 患者在记忆、语言能力、处理速度和 QoL-AD 方面有改善。未观察到其心理情感状态恶化。