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

A 期 IIA、多重、随机、双盲、安慰剂对照、阿尔茨海默病

• 批准号: 7608425
• 负责人: Paul S. Aisen
• 金额: $ 1.76万
• 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/7608425
• 关键词: Alzheimer' s Disease; Amyloid Proteins; Antibodies; Brain; Caregivers; Coin; Computer Retrieval of Information on Scientific Projects Database; Confusion; Double-Blind Method; Enrollment; Excision; Funding; Grant; Hour; Individual; Institution; Length; Medical History; Medicine; Memory Loss; Monitor; Neurologic Examination; Numbers; Paper; Participant; Patients; Persons; Pharmaceutical Preparations; Phase; Placebo Control; Placebos; Randomized; Research; Research Personnel; Resources; Safety; Screening procedure; Site; Source; Symptoms; Testing; Thinking; Time; Transfusion; United States; United States National Institutes of Health; Veins; Visit; Week; Writing; intravenous administration

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.

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。 该研究将评估AAB-001（一种研究药物）是否安全、耐受性良好且有效用于轻度至中度 老年痴呆症AAB-001是一种抗体。AB-001不可用 在这项研究之外。希望AAB-001能附着在淀粉样蛋白上， 大脑中的蛋白质（被认为会导致记忆丧失和 帮助它从身体中移除。该研究正在美国约30个研究中心进行。每家临床试验机构将入组约6例患者。我们预计共有约180名患者进入本研究。研究共持续约117周（27个月）。在研究过程中，受试者将访问该机构至少25次。访视次数会有所不同，具体取决于您是否决定参加与完整研究相关的子研究。 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。如果主题合适，该人将 在6个不同的场合接受研究药物，每13周一次， 在65周的时间里。将要求受试者返回 研究中心进行额外的安全性访视52周（约117周[27 月）。 受试者将被分入两个治疗组之一， 研究：AAB-001或安慰剂。受试者接受AAB-001或安慰剂的机会大致相等。受试者接受的治疗将以完全随机的方式决定（类似于抛硬币），个人和您的医生都不知道哪种治疗是 正在接收。如果出现了问题，医生需要知道 治疗对象正在接受，他将能够发现这一点， 信息.研究药物通过静脉输注给药 (into静脉），每次给药约需1小时。长度 这些访视的时间会有所不同，因为受试者第一次和第二次 接受输血的人必须留在现场， 监测6小时。剩下的四次实验 接受输血，他们只需要在现场停留两个小时， 除了接受研究药物外，受试者在研究期间的不同访视时还将进行许多不同的检查和测试。您将被问及有关您的病史和您正在服用的其他药物的问题。将进行体格检查和神经系统检查。其他评估包括回答问题以及用笔和纸书写和绘画，每次可能需要您最多90分钟完成，您的研究伴侣或护理人员最多60分钟完成。