An Anti-Oxidant Compound to Slow Progression of Alzheimer's Disease
A scenario meant to stimulate discussion about the ethical issues that arise when study designs must include placebo controls and lengthy participation by Alzheimer's patients.
Previous studies indicate that vitamin E, also an anti-Oxidant, enables AD patients to live an estimated six months longer than a placebo group. These patients also had slightly better control of bodily functions (including bowel and bladder). This study will examine a new anti-Oxidant that may slow the progression of AD. In this study, patients/subjects are required to remain on this compound until death. Their longevity will be compared with a control group receiving a placebo.
Family members must agree to maintain anti-Oxidant use throughout all stages of the disease progression. Subjects are not allowed to take any cholinesterase inhibitors or other anti-dementia drugs during the study, which uses a placebo control.
- Why might it not be ethical to require subjects to stay on this compound throughout the entire course of the disease, including the advanced stage?
- What would be the therapeutic goals of slowing progression of the disease?
- What do you think about the non-use of symptomatic anti-dementia drugs in subjects and controls?
Caroline Whitbeck introduced methods and modules for discussing numerous issues in responsible conduct of research at a Sigma Xi Forum in 2000. Partial funding for the development of this material came from an NIH grant.
You can find the entire sequence on the OEC at Scenarios for Ethics Modules in the Responsible Conduct of Research. Some information in these historical modules may be out-of-date; for instance, there may be a new edition of the professional society's code that is referred to in an item. If you have suggestions for updates, please contact the OEC.