Study: Certain Groups Underrepresented in Alzheimer's Trials
Clinical trials on Alzheimer’s disease provide critical information to the entire community. However, what if those trials are missing some important subgroups, such as people who are cared for by someone other than their spouse? Or, more importantly, people with Alzheimer’s disease who are from different ethnic groups? That actually appears to be the case.
A new study out of the University of California Los Angeles’s Mary S. Easton Center for Alzheimer’s Disease Research found that there are, indeed, some missing subgroups in the representation of people with Alzheimer’s disease in clinical trials. In this study, the research team looked at six clinical trials that were conducted by the Alzheimer’s Disease Cooperative Study. They sorted the study participants by the type of study partner – spouse, adult child or other study partner – who was participating with them.
The researchers’ analysis found that people who have Alzheimer’s disease and who don’t have a spouse may be underrepresented in Alzheimer’s disease clinical trials. Their analysis determined that 67 percent of participants in the six clinical trials were enrolled with spouse study partners, as compared to 26 percent with adult children study partners and 7 percent of other study partners.
“Nationwide, half of all unpaid Alzheimer’s disease caregivers are under the age of 50 and as many as 68 percent are the children, children-in-law or grandchildren of these patients,” Dr. Joshua D. Grill, an assistant professor of neurology at the UCLA Mary S. Easton Center for Alzheimer’s Disease Research and the study’s author, said in a press release. “In contrast, in our analyses, 67 percent of the 2,041 Alzheimer’s clinical trial participants had a spouse as their study partner. We found that there were several differences between people with spouse and adult child study partners that could affect the results of the trials and interpretations of those results.”
There also was a difference in groups as far as which study participants dropped out of the studies. The researchers found that participants who had spouse partners had a lower dropout rate (25 percent) than participants who had adult child study partnerships (32 percent) and other study partners (34 percent. The researchers also determined that participants who had study partners who were classified as “other study partner” were 70 percent more likely to drop out of the studies.
Race and caregiver attitudes also were identified as possibly having an effect on recruitment for trials. The researchers pointed out that only five percent of people who were Hispanic were participating in Alzheimer’s clinical trials. Of those, researchers found that people who had an adult child as a study partner were twice as likely to participate then those who had a spouse partner. Furthermore, six percent of participants in Alzheimer’s clinical trials were African Americans; in this group, people who had adult child study partners were almost three times more likely to participate than people who had a spouse as a study partner.
The researchers concluded that in order to increase the enrollment in clinical trials of people with Alzheimer’s disease who have caregivers who are not spouses may mean identifying additional recruitment strategies as well as strategies to help these participants and their caregivers remain in the study for the duration.
So how can you or a loved one who has Alzheimer’s disease find a clinical trial? The Alzheimer’s Association has developed TrialMatch, a free service that helps people with Alzheimer’s disease, caregivers, families and physicians local clinical trials based on specific criteria, such as diagnosis or stage of disease, and location. More than 100 research studies are currently underway and are in need of volunteers. The listing comes from publicly available sources as well as research facilities and trial sites across the nation. In order to be included in TrialMatch, these sites must submit proof that their research has been approved by the institutional review board, which approves, monitors and reviews research involving humans in order to protect their rights and welfare. The trials also are reviewed by the Alzheimer’s Association’s staff prior to being listed to make sure that they are credible.
Primary Sources for This Sharepost:
Alzheimer’s Association. (ND). About Alzheimer’s Association TrialMatch.
American Academy of Neurology. (2012). People without spouses under-represented in Alzheimer’s clinical trials. Press release.
Grill, J. D., et al. (2012). Effect of study partner on the conduct of Alzheimer disease clinical trials. Neurology.
Preidt, R. (2012). Studies of Alzheimer’s caregivers may overlook non-spouses. MedlinePlus.