A PHASE IIA, MULTICTR, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ALZHEIMER'S

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。 这项研究将评估AAB-001，一种研究药物，是否安全，耐受性良好，对于轻度到中度患者是否有效 阿尔茨海默氏症。AAB-001是一种抗体。AB-001不可用 在这项研究之外。AAB-001有望附着在淀粉样蛋白上 大脑中的蛋白质(被认为会导致记忆力丧失和 困惑)，并有助于将其从身体中移除。这项研究正在美国约30个地点进行。每个站点将招收大约6名患者。我们预计总共约有180名患者进入这项研究。这项研究总共持续了117周(27个月)。在研究过程中，参与者将至少参观该设施25次。访问的次数不同，取决于您是否决定参加与完整研究相关的子研究。 在最初的筛查访问以检查受试者的适合性之后 为了参与，个人将被安排在两种治疗中的一种 对整个研究进行分组。如果主题合适，此人将 接受6次不同的学习药物治疗，每13周一次， 在65周的时间里。受试者将被要求返回到 再进行52周的额外安全检查(约117周[27 月数])。 受试者将被分成两个治疗组中的一个 研究：AAB-001或安慰剂。受试者将有大致相同的机会接受AAB-001或安慰剂。受试者接受的治疗将以完全随机的方式决定(类似于掷硬币)，个人和你的医生都不知道哪种治疗是 被接待。如果出现问题，医生需要知道 如果受试者正在接受治疗，他将能够发现这一点 信息。学习药物是以静脉输液的形式给予的。 (变成静脉)，每次大约需要1个小时。它的长度 这些访问的情况有所不同，因为第一次和第二次的主题 接受输血，人必须留在现场才能 监控了六个小时。剩下的四次受试者 接受输血，他们只需要在现场停留两天 除了接受学习药物，受试者还将在研究过程中在不同的访问中接受一些不同的检查和测试。你会被问及你的病史以及你正在服用的其他药物。将进行身体和神经检查。其他评估包括回答问题以及用笔和纸书写和绘画，每次您可能需要最多90分钟来完成，您的学习伙伴或照顾者可能需要最多60分钟来完成。

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 study will assess whether AAB-001, an investigational medication, is safe, well tolerated and effective for use in persons with mild to moderate Alzheimer's disease. AAB-001 is an antibody. AB-001 is not available outside of this study. It is hoped that AAB-001 will attach to amyloid protein in the brain (thought to cause symptoms like memory loss and confusion) and help in its removal from the body. The study is being conducted at approximately 30 sites in the United States. Approximately 6 patients will be enrolled per site. In total, we expect about 180 patients to enter this study. The study lasts about 117weeks (27 months) in total. There are at least 25 times over the course of the study that participants will visit the facility. The number of visits varies, depending on whether you decide to participate in substudies related to the full study. After an initial screening visit to check on the subject's suitability to participate, individuals will be placed in one of two treatment groups for the entire study. If the subject is suitable, the person will receive study medicine on 6 separate occasions, once every 13 weeks, over a period of 65 weeks. The subject will be asked to return to the site for additional safety visits for 52 more weeks (about 117 weeks [27 months] in total). Subjects will be placed in one of two treatment groups for the entire study: AAB-001 or placebo. Subjects will have an approximately equal chance of receiving AAB-001 or placebo. The treatment a subject receives will be decided in a completely random way (similar to the flip of a coin), and neither the individual nor your doctor will know which treatment is being received. If a problem occurs and the doctor needs to know which treatment a subject is receiving, he will be able to find out this information. The study medicine is given as an intravenous infusion (into a vein), and takes about 1 hour to be given each time. The length of these visits will vary, as the first and second time the subject receives the transfusion, the person has to stay at the site to be monitored for a six hour period. The four remaining times the subject receives the transfusion, they only need to stay at the site for two hours afterwards.In addition to receiving the study medicine, a subject will have a number of different examinations and tests during the study at different visits. You will be asked questions about your medical history and what other medicines you are taking. Physical and neurological examinations will be performed. Additional assessments involve answering questions and writing and drawing with pen and paper, and may take up to 90 minutes for you to complete and up to 60 minutes for your study partner or caregiver to complete, on each occasion.