A new clinical trial for Alzheimer's disease is offered in your community, and you feel that your mother, who has the condition, may benefit. Would you sign her up even if she didn't have the wherewithal to consent? A new survey of seniors indicates that most would enroll a loved one in such a study, even if it were somewhat risky. The findings are likely to feed into the debate about whether there should be a national standard on surrogate decision-making for those suffering from Alzheimer's.
Clinical trials carry the promise of developing better therapies for a variety of diseases, but some people who might be eligible to participate cannot enroll themselves. State laws vary on whether patients with diseases that impair cognition such as Alzheimer's can be signed up for these trials without their consent. When structuring these laws, politicians usually turn to experts and do not rely on the opinions of family members of afflicted patients, says Scott Kim, a psychiatrist at the University of Michigan Medical School in Ann Arbor.
So Kim and University of Michigan colleague Hyung Jin Kim teamed up with researchers at the University of Rochester Medical Center in New York to develop a survey that would target those likely to confront Alzheimer's disease. The survey detailed 10 research scenarios, varying from low-risk research studies (involving only observation or blood draws) to high-risk studies (involving spinal taps, clinical drug trials, vaccines, or gene transfer). For each type of study, volunteers were asked how likely they would be to enroll a loved one with Alzheimer's disease who could not make the decision for him- or herself.
Two hundred and twenty-nine people took the survey. All were age 70 or older and had recently participated in a long-term medication study. Almost 90% agreed that they would "probably" or "definitely" enroll a loved one with Alzheimer's disease in low-risk studies as well as drug trials. In addition, 61% said they would "probably" or "definitely" enroll loved ones in studies involving spinal taps, and 62% would enroll them in vaccine studies. Even for the riskiest study--gene transfer--almost half (45%) of those surveyed would "probably" or "definitely" enroll a loved one. Participants responded similarly when asked if they would participate in the studies themselves, demonstrating that they were willing to accept the same risks as their loved ones, the researchers report 8 November in Neurology.
This study shows that people are surprisingly more willing to enroll their loved ones in high-risk studies than previously thought, says geriatric psychiatrist Richard Powers, a board member of the Alzheimer's Foundation of America. Future public debate on consent for Alzheimer's studies needs to "be more inclusive" of families and patients affected by the disease, he says.