PHASE 3 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE E

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。 这项研究使用了一种名为MPC-7869的研究药物， 这还没有得到美国食品和药物管理局的批准 (FDA)。MPC-7869是试验性的。Myriad制药公司赞助了这项研究。其目的是观察MPC-7869与安慰剂(一种医学上的非活性物质)在阿尔茨海默病患者的认知(思维和记忆)、一般精神表现和日常生活能力方面的有效性。此外，在第二次访问中，受试者将可以选择参与一项涉及额外血液样本的遗传子研究。该分研究有单独的知情同意书(ICF)。 这项研究正在130个地点进行。大约10-12名患者 将在每个站点注册。我们预计总共约为1600-1700 患者进入这项研究。这项研究总共持续了大约20个月。 课程中有10次学习访问和10次电话联系。 这项研究的结果。考察访问可能需要长达3个小时。 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。受试者将有二分之一的机会(50%) 被分配到任一学习小组。无论是研究对象还是研究对象 医生将知道一个人在研究中属于哪个研究小组 可以找出受试者在紧急情况下服用的是哪种研究药物。 受试者将服用这种研究药物18个月。研究药物将是 每日两次，每次2片，随餐或零食服用。 大约相隔12个小时。在整个研究过程中，受试者将定期接受体检、血液检查和记忆力测试。研究伙伴或照顾者将确保研究药物的正确使用，并在整个研究过程中完成各种调查和问卷调查。

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 study involves use of an investigational drug called MPC-7869, which has not been approved by the U.S. Food and Drug Administration (FDA). MPC-7869 is experimental. Myriad Pharmaceuticals, Inc. sponsors this study. Its purpose is to look at the effectiveness of MPC-7869 compared to placebo (a medically inactive substance) on the cognition (thinking and memory), general mental performance, and activities of daily living in subjects with Alzheimer's disease. Additionally, at Visit 2, subjects will have the option of participating in a genetic sub study that involves an additional blood sample. A separate Informed Consent Form (ICF) exists for that substudy. The study is being conducted at 130 sites. Approximately 10-12 patients will be enrolled at each site. In total, we expect about 1600-1700 patients to enter this study. The study lasts about 20 months in total. 10 study visits and 10 telephone contacts take place over the course of the study. Study visits may take up to 3 hours. 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. Subjects will have a 1 in 2 chance (50%) of being assigned to either study group. Neither the subject nor the study doctor will know which study group an individual is in The study doctor can find out which study drug a subject is taking in case of an emergency. Subjects will take the study drug for 18 months. The study drug will be given as 2 tablets twice a day and should be taken with meals or a snack about 12 hours apart. Throughout the study, subjects will periodically undergo physical exams, blood work, and memory testing. The study partner, or caregiver, will ensure proper use of study medication as well as complete various surveys and questionnaires throughout the study.