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Research Safety in Fight Against Alzheimer's

Posted on: Thursday, 10 November 2005, 06:00 CST

By Lee Bowman

People at heightened risk for Alzheimer's are surprisingly willing to take risks with those having the memory-robbing disease in the search for a cure, according to a new survey.

In all, 90 percent of the 229 elderly adults in the study said it would be all right to allow a family member to enroll a person with Alzheimer's in studies that involved mild to medium risks, such as research on new drugs. All the participants were over age 70 and had at least one close blood relative diagnosed with any kind of dementia.

Slightly more than half said that even high-risk research scenarios, such as experiments involving gene transfers, would be acceptable with a surrogate's consent.

"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," said Dr. Scott Kim, an assistant professor of psychiatry at the University of Michigan and lead author of the study, published Tuesday in the journal Neurology.

"Our study aims to provide data about the attitudes of key stakeholders that policymakers can use," added Kim, who focuses on the ethics of research involving people who cannot grant consent for medical experiments due to diminished capacity from dementia or other mental illness.

Researchers have been working with new drugs and vaccines designed to trigger the immune system to fight the brain inflammation and nerve-cell tangles that are the hallmarks of Alzheimer's. However, all present safety risks.

A safety oversight board recently stopped one national vaccine study after some patients experienced brain inflammation. Two patients in a recent California gene-therapy trial experienced bleeding in the brain.

In addition, researchers trying to better understand Alzheimer's are using brain-scanning techniques and collecting samples of blood and spinal fluid from patients, although the work offers no possibility of immediate benefit to those patients.

In general, respondents in the Neurology study were more likely to support the idea that a family member should be able to give consent for research when they assumed they would become research subjects. However, the respondents were somewhat less enthusiastic about granting such permission for someone else.

For instance, a study that would involve a spinal tap was approved of by 69 percent when they would be the subjects, but by 61 percent as something they would authorize for a family member.

Kim noted that the survey results should be interpreted cautiously, because the study participants were already participating in an Alzheimer's-prevention study involving anti- inflammatory drugs, making them probably more pro-research than the average American.

Source: Cincinnati Post

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