SAFETY AND EFFECTIVENES OF IMMUNE GLOBULIN INTRAVENOUS

静脉注射免疫球蛋白的安全性和有效性

• 批准号: 7952022
• 负责人: RAYMOND SCOTT TURNER
• 金额: $ 0.43万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952022
• 关键词: Albumins; Alzheimer' s Disease; Biological Markers; Categories; Cholinesterase Inhibitors; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; DNA Library; Dementia; Dose; Funding; Grant; Healthcare; Infusion procedures; Institution; Intravenous Immunoglobulins; Magnetic Resonance Imaging; Measures; Memantine; Placebos; Plasma; Research; Research Personnel; Resources; Safety; Source; United States National Institutes of Health; base; instrument; neuropsychiatry; routine therapy; trial comparing

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).

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项（A 类）NIA-ACDS/Baxter Healthcare 赞助的为期 20 个月（76 周）的试验，比较两种剂量的 IVIG（200 或 400 mg/kg，每 2 周 x 36 次输注）与安慰剂（0.25% 白蛋白）降低的效果已经接受常规治疗（胆碱酯酶抑制剂或美金刚）的轻中度阿尔茨海默病导致的痴呆症进展。 主要终点基于 ADAS-Cog 和 ADAS-CGIC 仪器。 次要指标包括其他神经精神指标、资源利用、安全性和耐受性、血浆生物标志物以及（非对比）MRI 的变化。 有可选的子研究，允许 10 年 DNA 库、CSF 生物标志物重复 LP（基线、9 个月和 18 个月）和/或 FDG-PET（基线和 9 个月）。