PHASE II STUDY OF IVIG FOR ALZHEIMER'S DISEASE

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。这项双盲II期研究的总体目标是进一步评估IVIg治疗阿尔茨海默病（AD）的安全性、有效性和生物学效应。本研究将在一个研究中心（康奈尔大学威尔医学院/纽约长老会医院）进行。将24名能够给予或委托知情同意的轻度至中度AD患者随机分配接受IVIg或生理盐水安慰剂治疗6个月。本研究包括四种IVIg给药方案（0.4g/kg/2周、0.8g/kg/4周、0.2g/kg/2周和0.4g/kg/4周）的比较。患者将有33%的机会接受安慰剂。将在基线、治疗3个月和6个月时以及患者未接受研究药物的6周洗脱期后收集认知、行为和功能指标。将在研究药物输注前后采集血浆样本，受试者将在6个月治疗前后接受腰椎穿刺，以进行脑脊液（CSF）生物标志物分析。此外，将在研究期间的两个时间点进行正电子发射断层扫描（PET）成像子研究。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The overall goal of this double-blind Phase II study is to further evaluate the safety, efficacy and biological effects of IVIg in the treatment of Alzheimer's disease (AD). This study will be carried out at a single site (Weill Medical College of Cornell University/New York Presbyterian Hospital). 24 patients with mild to moderate AD capable of giving or delegating informed consent will be randomly assigned to receive either IVIg or saline placebo for six months. This study includes comparison of four dosing regimens of IVIg (0.4g/kg/2 weeks, 0.8g/kg/4weeks, 0.2g/kg/2weeks and 0.4g/kg/4 weeks). Patients will have a 33% chance of receiving placebo. Cognitive, behavioral and functional measures will be collected at baseline, three months and six months of treatment and after a six-week washout period during which patients receive no study drug. Plasma samples will be collected before and after infusions of study drug, and subjects will undergo a lumbar punctures before and after the six months of treatment for cerebrospinal fluid (CSF) biomarker analyses. In addition, Positron Emission Tomography (PET) imaging substudies will be performed at two timepoints during the study.