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Survey Looks at Ethics of Alzheimer's Trials

Most said they would allow the participation of an ill loved one

Please note: This article was published more than one year ago. The facts and conclusions presented may have since changed and may no longer be accurate. And "More information" links may no longer work. Questions about personal health should always be referred to a physician or other health care professional.

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TUESDAY, Nov. 8, 2005 (HealthDay News) -- The majority of Americans approve of allowing patients with Alzheimer's disease to be enrolled in research studies -- even when they aren't able to provide their own consent, new research shows.

Ninety percent of the 229 study participants in the University of Michigan/University of Rochester study said it would be appropriate to allow family members to enroll Alzheimer's patients in research that involved mild-to-medium risks, including the testing of new drugs. A majority of the participants also approved of this kind of surrogate decision-making in studies that would involve spinal taps, brain tissue sampling, gene transfers, and testing of Alzheimer's protein "vaccines."

When the study participants were asked what kinds of studies they would approve if they were making surrogate decisions for someone they personally knew and loved, the percentages declined only slightly, especially when it came to low-risk studies.

All the study participants were over age 70 and at heightened risk of developing Alzheimer's -- all had at least one close blood relative diagnosed with dementia and all were taking part in a study looking at the use of anti-inflammatory drugs to prevent dementia.

The findings appear in the November issue of Neurology.

Currently, there is no U.S. national standard for how and when surrogates can make research enrollment decisions for people who, due to dementia, are unable to make their own decisions. U.S. federal law does allow surrogates to make these decisions but it's left up to individual states to set specific rules.

The study authors believe consistent national standards are needed and that their research may help guide policymakers.

"Right now, Alzheimer's studies being done in one state could be illegal in others, and most states such as Michigan have no clear law on this issue. Though individual research institutions such as universities do their best to protect research participants, they deserve better policy guidance than what they have now," study lead author Dr. Scott Kim, a University of Michigan assistant professor of psychiatry, said in a prepared statement.

More information

The Fisher Center for Alzheimer's Research Foundation has more about taking part in a clinical trial.

SOURCE: University of Michigan Health System, news release, Nov. 7, 2005


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