SAFETY AND EFFECTIVENES OF IMMUNE GLOBULIN INTRAVENOUS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项由NIA-ACDS/Baxter Healthcare赞助的为期20个月(76wk)的(A类)试验，比较了两种剂量的IVIG(200或400 mg/kg，Q 2wk×36次输液)和安慰剂(0.25%白蛋白)以减少由于已经在接受常规治疗(胆碱酯酶抑制剂或美金胺)的轻中度阿尔茨海默氏病而导致的痴呆的进展。主要终端基于ADAS-Cog和ADAS-CGIC仪器。次要指标是其他神经精神指标、资源利用率、安全性和耐受性、血浆生物标记物和(非对比)MRI的变化。有可选的子研究，允许DNA储存10年，重复LP检测脑脊液生物标记物(基线、9个月和18个月)和/或FDG-PET(基线和9个月)。

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. This is a (Category A) NIA-ACDS/Baxter Healthcare-sponsored 20 month (76 wk) trial comparing two doses of IVIG (200 or 400 mg/kg, q 2wk x 36 infusions) with placebo (0.25% albumin) to decrease the progression of dementia due to mild-moderate Alzheimer's disease already on routine therapy (cholinesterase inhibitors or memantine). Primary endpoints are based on ADAS-Cog and ADAS-CGIC instruments. Secondary measures are other neuropsychiatric measures, resource utilization, safety and tolerability, plasma biomarkers, and changes in (noncontrast) MRI. There are optional sub-studies which would allow 10y banking of DNA, repeated LP for CSF biomarkers (at baseline, 9 mo, and 18 mo), and/or FDG-PET (at baseline and 9 mo).