Objective: To present some of the ethical concerns pertaining to the anticipated use of apolipoprotein E genotyping in selecting therapy in Alzheimer's disease.
Method: We review studies that support the utility of apolipoprotein E (APO E) genotyping for predicting drug responsiveness along with the published consensus statements and position papers related to APO E genotyping. Ethical issues pertaining to the use of APO E genotyping for pharmacogenetic purposes have not yet been fully explored, and these are discussed.
Results: This paper explores the bioethics surrounding the use of APO E genotyping for pharmacogenetic purposes. The rapidly increasing pace of clinical trials in Alzheimer's disease necessitates a critical examination of the evolving ethical issues. A framework for establishing guidelines is suggested.
Conclusions: Clinical research trials for Alzheimer's disease with a genotyping component will increasingly be influenced by and benefit from a serious analysis of the ethics emerging alongside the scientific and clinical advances.