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On July 23, 2012, Pfizer announced that the primary clinical endpoints—change in cognitive abilities and change in daily functioning—compared to placebo, were not met in the Janssen Alzheimer Immunotherapy Phase 3 trial of intravenous (IV) bapineuzumab in patients with mild-to-moderate Alzheimer’s disease who carry the ApoE4 (apolipoprotein E epsilon 4) genotype (the ELN 302 study).
Because bapineuzumab was not effective in this study of patients with Alzheimer’s disease who have an ApoE4 gene, the Janssen AI and Pfizer Joint Steering Committee has decided that participants in this study who enrolled in a follow-on extension study will no longer receive doses of bapineuzumab. However, these patients will have a follow-up evaluation.
Based on a comprehensive review of the data by the independent safety monitoring committee, all other bapineuzumab studies (for non ApoE4 carriers) are continuing as planned and without modifications. The subjects in the Pfizer bapineuzumab study (for ApoE4 carriers) will have the option to continue in the study.
It is important to note that the extension study is not ending because of safety concerns, but rather because the data were showing that the study drug was not helping people improve compared to placebo.
If you or a loved one are enrolled in a bapineuzumab study at the Penn Memory Center, you can expect a phone call from your research coordinator shortly. If would like to speak with them sooner, please contact the coordinator for the study in which you are enrolled (Janssen – Patricia Martinez: 215-746-2557 or Pfizer – Jessica Nunez: 215-662-4379.)
About Alzheimer’s disease
Alzheimer’s disease, the most common form of dementia, is a degenerative brain disease that is not a normal part of aging. Currently there is neither a cure nor a treatment that delays the course of Alzheimer’s disease, which gradually destroys a person’s cognitive and functional abilities, including memory and the ability to perform activities of daily living, such as bathing and eating. Alzheimer’s disease is the sixth leading cause of death in the United States, estimated to affect more than five million people. It is estimated that there were 35.6 million people with dementia, including Alzheimer’s disease, worldwide in 2010. This number is projected to nearly double every 20 years, increasing to 65.7 million in 2030 and 115.4 million in 2050 worldwide. Furthermore, the total worldwide costs of dementia, including Alzheimer's disease, were estimated around one percent of global gross domestic product (GDP) in 2010, at more than US $600 billion. This includes costs attributed to informal unpaid care, community or residential-based care and treatment.