Extension Trial of Bapineuzumab Alzheimer Disease ApoE4 Carriers

• Research type

  Research Study

• Full title

  A Phase 3 Extension, Multicenter, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotein E e4 Carriers and Participated in Study 3133K1-3001-WW

• IRAS ID

  37000

• Contact name

  Roger Bullock

• Sponsor organisation

  Pfizer Ltd

• Eudract number

  2009-015080-13

• ISRCTN Number

  N/A

• Research summary

  This is an extension study of protocol 3133K1-3001-WW. The purpose of this study is to test if the study drug, Bapineuzumab, is safe, and well tolerated when taken during a period of time longer than 18 months in participants with mild to moderate Alzheimer's Disease. Another purpose of this study is to explore the effect of Bapineuzumab on Alzheimer??s disease using tests that show how participants are doing over time with memory, day to day activities, and other measures of brain function and disease. Only participants who have completed the research study 3133K1-3001-WW will be approached to participate in this study. The experimental part of this study is the use of an antibody to treat Alzheimer??s disease. An antibody is a protein found in the blood, and used by the immune system to identify and neutralize foreign objects such as bacteria and viruses. Bapineuzumab is an antibody that is not commonly found in patients?? blood. It is designed to bind to a particular protein, called beta amyloid protein. In patients with Alzheimer??s disease, beta amyloid protein accumulates in the brain and forms plaques, thought to be related to the progression of the disease. It is hoped that Bapineuzumab will attach to the beta amyloid protein in the brain and help the body to remove it.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/117

• Date of REC Opinion

  17 Feb 2010

• REC opinion

  Further Information Favourable Opinion