PH 3 MULTICTR, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY- ALZHEIMER'S

PH 3 多重、随机、双盲、安慰剂对照研究 - 阿尔茨海默病

• 批准号: 7608427
• 负责人: Paul S. Aisen
• 金额: $ 2.28万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608427
• 关键词: Activities of Daily Living; Alzheimer' s Disease; Blood; Blood specimen; Caregivers; Cognition; Computer Retrieval of Information on Scientific Projects Database; Consent Forms; Double-Blind Method; Effectiveness; Emergency Situation; Enrollment; Ensure; Funding; Genetic; Grant; Hour; Individual; Institution; Investigational Drugs; Memory; Patients; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Placebos; Psyche structure; Purpose; Questionnaires; Randomized; Research; Research Personnel; Resources; Screening procedure; Short-Term Memory; Site; Source; Study Subject; Surveys; Tablets; Telephone; Testing; Thinking; United States Food and Drug Administration; United States National Institutes of Health; Visit; day; placebo controlled study

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。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 研究中心，而研究中心不一定是研究者所在的机构。 这项研究涉及使用一种名为MPC-7869的研究药物， 这种药物还没有得到美国食品和药物管理局的批准 （FDA）。MPC-7869是实验性的。Myriad Pharmaceuticals，Inc.赞助这项研究。其目的是观察MPC-7869与安慰剂（一种医学上无活性的物质）相比对阿尔茨海默病受试者的认知（思维和记忆）、一般心理表现和日常生活活动的有效性。此外，在访视2时，受试者可以选择参加涉及额外血液样本的遗传子研究。该子研究有单独的知情同意书（ICF）。 该研究正在130个研究中心进行。约10-12名患者 将在每个研究中心入组。总的来说，我们预计约1600-1700 患者进入本研究。这项研究总共持续了大约20个月。 课程期间进行10次考察访问和10次电话联系 的研究。研究访视可能需要长达3小时。 首次筛选访视后，检查受试者的适用性 参与者将被安排接受以下两种治疗之一 整个研究的组。受试者将有1/2的机会（50%） 被分配到任何一个研究组。无论是研究对象还是研究 医生将知道个体属于哪个研究组研究医生 可以了解受试者在紧急情况下正在服用哪种研究药物。 受试者将服用研究药物18个月。研究药物将 每天两次，每次两片，应随餐或零食服用 大约相隔12小时在整个研究期间，受试者将定期接受体格检查、血液检查和记忆力测试。研究伴侣或护理人员将确保研究药物的正确使用，并在整个研究期间完成各种调查和问卷。