Author(s): Stephen Post, Ph.D.
The estimated lifetime risk rises from 20% to 40% for people who have first-degree relatives (a parent or sibling) with alzheimer's disease (AD). This study involves the first randomized double-blind controlled study of hormonal replacement in post-menopausal women at higher risk for AD because of first-degree relatives.
The informed consent form indicates that the protective value of hormonal replacement has not yet been firmly established. It is, however, widely known that hormonal replacement has other benefits for women, including the preservation of bone density. Furthermore, the protective benefits with respect to the onset of dementia have been widely asserted based on retrospective observational studies.
Why might a placebo control study be considered unethical in this context?
How should the risks and benefits of entering such a study be explained?