Boada-Rovira Mercè
Fundacio ACE. Institut Catala de Neurociencies Aplicades, 08014 Barcelona, Espana.
Rev Neurol. 2010 Mar 16;50 Suppl 5:S9-18.
Results from a pilot study and its 2-year extension (IG0502) performed on patients with mild or moderate Alzheimer's disease revealed a tendency towards clinical stabilization after a plasmapheresis program with plasma exchange with therapeutic albumin Human Albumin Grifols 5%. Plasma levels of Alphabeta(40) and Alphabeta(42) presented a saw-tooth pattern associated to plasma exchanges. These findings encouraged a new randomized, controlled, parallel, blind study (IG0602) to confirm our previous working hypotheses, i.e. that Alphabeta(40) and Alphabeta(42) concentrations in plasma were modified pre- and post plasmapheresis with Human Albumin Grifols 5% and, in the clinical area, that the cognitive capabilities of patients could be stabilized or even improved. Other aims of the study were focused on neuroimaging evaluation of structural and functional changes in the brain the by means of magnetic resonance and single-photon emission computerised tomography.
Preliminary results from the randomized study carried out after a follow-up of one year of the first 29 patients (80% of the recruited) show a clear difference between the treated and the control groups with regard to the levels of Alphabeta(40), both in plasma and in cerebrospinal fluid, that are associated with the plasma exchanges. This pattern is not so evident for Alphabeta(42). Regarding cognitive performance, the treated group scored better than the control group after the period study, according to the evaluation performed by using the Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) tests.
These preliminary results suggest that plasmapheresis with plasma exchange with Human Albumin Grifols 5% may have a promising future as a treatment of mild-moderate Alzheimer's disease.
一项针对轻度或中度阿尔茨海默病患者开展的初步研究及其为期2年的扩展研究（IG0502）结果显示，采用5%人血白蛋白Grifols进行血浆置换的血浆置换程序后，有临床病情稳定的趋势。血浆中αβ(40)和αβ(42)水平呈现出与血浆置换相关的锯齿状模式。这些发现促使开展一项新的随机、对照、平行、盲法研究（IG0602），以证实我们之前的工作假设，即采用5%人血白蛋白Grifols进行血浆置换前后，血浆中αβ(40)和αβ(42)浓度会发生改变，并且在临床方面，患者的认知能力能够得到稳定甚至改善。该研究的其他目的集中在通过磁共振和单光子发射计算机断层扫描对大脑结构和功能变化进行神经影像学评估。
对首批29例患者（占招募患者的80%）进行一年随访后开展的随机研究的初步结果显示，治疗组和对照组在与血浆置换相关的血浆和脑脊液中αβ(40)水平方面存在明显差异。αβ(42)的这种模式不太明显。关于认知表现，根据使用简易精神状态检查表（MMSE）和阿尔茨海默病评估量表 - 认知（ADAS - Cog）测试进行的评估，治疗组在研究期后得分高于对照组。
这些初步结果表明，采用5%人血白蛋白Grifols进行血浆置换的血浆置换术作为轻度至中度阿尔茨海默病的治疗方法可能具有广阔前景。
