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Is it okay to sign Alzheimer's patients up for research studies?

ST. PAUL, Minn. Grandma has Alzheimer's disease should you sign her up for a new research study, even if she doesn't really understand what it entails? What if the research has real risks, is unlikely to benefit her, but could lead to advances that will help future patients with Alzheimer's? A new study sheds light on these questions, which may come up more often as potential treatments require more involved and invasive research.

"As potential new therapies such as vaccines, gene therapy, and new drugs are being tested, the need for research must be balanced with the need to protect vulnerable adults," said Scott Y. H. Kim, MD, PhD, of the University of Michigan Medical School in Ann Arbor. "This continues to be an area with unsettled policy, and there is little data to guide policymakers. It doesn't seem ideal to leave these important ethical questions solely to politics. This study shows that it's possible to learn the views of key stakeholder groups, and they can provide important insights."

People at heightened risk for Alzheimer's disease 229 people who were over 70 and had at least one close relative with the disease took part in the study, which is published in the November 8, 2005, issue of Neurology, the scientific journal of the American Academy of Neurology.

The participants were given 10 research scenarios and asked if the research portrayed was acceptable when it involves people with Alzheimer's who cannot give their own informed consent and are enrolled with a family member's permission.

They were asked to consider three perspectives: whether the research was acceptable from a societal perspective, from their own perspective (whether the participants would want a loved one to make the decision for them), and from the perspective of a surrogate (how they would make a decision for a loved one).

The 10 scenarios ranged from low-risk studies involving observation or routine blood draws to higher-risk studies li
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Contact: Marilee Tuite
mtuite@aan.com
651-695-2789
American Academy of Neurology
7-Nov-2005


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