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

这个子项目是众多研究子项目之一

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.