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

E 的 3 期多中心、随机、双盲、安慰剂对照研究

• 批准号: 7719049
• 负责人: Paul S. Aisen
• 金额: $ 2.43万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719049
• 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; Phase; 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.

这个子项目是众多研究子项目之一