Alzheimer's Disease and Research: Ethical Concerns

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Can patients with Alzheimer’s disease participate in clinical research? Theoretically, two radically opposite views regarding this issue can be posited. The first one, which is rather “conservative” could, in principle, argue that because of pervasive cognitive impairments AD patients are vulnerable and not capable of giving informed consent with a similar degree of responsibility as that of healthy individuals. When a surrogate’s decision is required for participation in research, this decision can never be equivalent with the actual patient’s decision, since no one can know exactly what the patient desires. This generates important issues concerning the participation of these patients in research especially under the light of the ethical principle of autonomy. There are a number of cases when this position is relevant: research involving health risks for the patient, minimal benefits compared with the risks, or the use of placebo.

The second view advocates the merits of research: AD research cannot be done without AD patients in all the stages of their disease. This is an indubitable fact, because how else can one track the development of the disease (especially the characteristic biological changes)? By invoking the argument of scientific progress and the possibility of finding a cure, the participation of Alzheimer’s disease patients in research is no longer a matter of possibility but of absolute necessity.

In this paper I will argue that despite the first view’s concerns being partly justified, they need not undermine the importance of Alzheimer’s patients’ participation in research. In the first section of the paper I will present some studies that support each of the views, then in the second part I...

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...s little information about the possible benefits of the study or the side effects. The side effects proved to be significant (gastrointestinal complains, headache, and an elevation of alanine aminotransferase), while the benefits were minimal. This situation emphasizes the need for a balanced approach when it comes to drug clinical trials.

In conclusion, patients with AD can participate in research provided that their decision- making ability is thoroughly examined. Otherwise, a proxy can decide because he usually acts in the best interest of the patient. To be considered ethical, the research project involving AD patients has to follow the guidelines of TCPS and be approved by a Research Ethics Board. In additon, autonomy, clinical equipoise and careful evaluation of benefits versus risks should be among the main ethical concerns of the study.
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