Can Alzheimer’s patients participate in research?
Can Alzheimer’s patients participate in research?
Survey respondents say, "Yes"
Is it ethical to enroll an elderly person with Alzheimer’s disease in a new research study, even if he or she doesn’t really understand what it entails? What if the research has real risks, is unlikely to benefit the patient, but could lead to advances that will help future patients with Alzheimer’s?
Questions like these are likely to arise more often as potential treatments evolve that require more involved and invasive research, and 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, according to 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. Kim and his colleagues conducted a study of what adults at risk of Alzheimer’s disease think about participating in research.
People at heightened risk for Alzheimer’s disease — 229 people who were more than 70 and had at least one close relative with the disease — took part in the study, which was published in the Nov. 8, 2005, issue of Neurology, the journal of the American Academy of Neurology.
Testing patients OK, to a point
The participants were given 10 research scenarios and asked if the research portrayed was acceptable if it involves people with Alzheimer's disease who cannot give informed consent on their own but 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 like testing a potential vaccine or a neurosurgical gene transfer intervention. The survey participants were told about the risks and any potential benefits to subjects or to society.
More than 90% of the participants felt that minimal risk studies as well as randomized clinical trials of new medicines should be allowed with incompetent Alzheimer’s subjects if family members give permission, according to Kim. A smaller percentage, but still a majority, approved of such surrogate decision making for studies involving gene transfers Alzheimer’s protein "vaccines," spinal taps and brain tissue sampling.
In general, participants endorsed family consent for research most strongly when applied to themselves as future research subjects and least strongly when placing themselves in the position of the surrogate having to decide for a loved one. For example, for a study that would involve a lumbar puncture, family consent for research was endorsed by 69% when applied to themselves as future subjects; by 65% from a social policy perspective; and by 61% as something they would allow for a loved one.
The participants perceived the highest risk from studies involving gene transfer, Alzheimer’s vaccine and brain biopsy or tissue sampling. But despite the risk, more than 50% said they thought it was acceptable for society to allow such studies, and a majority said they would probably or definitely take part. When asked if they would consent to allow a loved one to take part, the percentage saying probably or definitely yes fell just below 50% for gene transfer and biopsy.
Participants were more likely to find the research scenarios acceptable if they had a generally supportive attitude toward biomedical research. The study participants were already taking part in an Alzheimer's disease anti-inflammatory prevention research study; the researchers note that the participants therefore could be more supportive of research than the typical person at risk for Alzheimer’s.
However, those taking part in the study were fairly typical demographically to people taking part in other studies of Alzheimer’s disease, so they may be quite similar to those likely to be considered for future research studies, Kim adds.
"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," he says. "Our study aims to provide data about the attitudes of key stakeholders that policymakers can use."
For more information and to see full results of the study, go to the American Academy of Neurology web site, www.aan.com.
Is it ethical to enroll an elderly person with Alzheimers disease in a new research study, even if he or she doesnt really understand what it entails? What if the research has real risks, is unlikely to benefit the patient, but could lead to advances that will help future patients with Alzheimers?Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.