PHILADELPHIA - People with Alzheimer's disease are less likely to participate in a clinical trial if they have non-spouse caregivers, according to a study by a team of researchers including the Perelman School of Medicine at the University of Pennsylvania. The new study, published in the December 19th, 2012, issue of Neurology®, the medical journal of the American Academy of Neurology, demonstrates that additional recruitment and retention strategies may be required to increase enrollment of AD patients with caregivers other than spouses.
Alzheimer's trials - which require both the patient with Alzheimer's and a reliable study partner to enroll together - often struggle to recruit enough patients. In this study,two-thirds of Alzheimer's clinical trial participants were accompanied by their spouse, in contrast to the national average showing that 68 percent of people with Alzheimer's primarily receive care from their children, children-in-law or grandchildren. The study also found that AD participants with a study partner who was neither a spouse nor an adult child were more likely to drop out before the study completed. In addition, these participants were more likely to suffer a serious adverse event during the trial.
"The majority of Alzheimer's patients are cared for by caregivers who are not their spouses, but we discovered that in Alzheimer's disease clinical trials, most patients' caregivers are their spouses," said senior study author Jason Karlawish, MD, co-director of the Penn Memory Center and professor of Medicine, Medical Ethics and Health Policy in the Perelman School of Medicine at the University of Pennsylvania. "This result is a call to action. Nonspousal caregivers and the patients they care for represent an untapped opportunity to increase recruitment into Alzheimer's clinical trials and to assure that the research results reflect the broad community of patients and their caregivers."
The study also found variations in demographics that may be relevant to clinical trial designs. For example, only five percent of participants across the trial were Hispanic and those with an adult child study partner were twice as likely as those with spouse partners to be Hispanic. In addition, six percent of participants were African-American and those with adult child study partners were nearly three times as likely to be African-American as those with spouse study partners. And, while the ratio of men and women with Alzheimer's disease was similar, the majority of study partners/caregivers were female.
The study analyzed six Alzheimer's Disease Cooperative Study (ADCS) randomized clinical trials, with a total of 2,041 trial participants. In addition to Dr. Karlawish, the research team included experts at the University of California, Los Angeles (UCLA) and the University of California, San Diego (UCSD).
The study was supported by the National Institute on Aging (AG016570, P30-AG01024, U01-AG10483), the Sidell-Kagan Foundation and the Marian S. Ware Alzheimer Program.
Penn Medicine is one of the world's leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $4.3 billion enterprise.
The Perelman School of Medicine is currently ranked #2 in U.S. News & World Report's survey of research-oriented medical schools. The School is consistently among the nation's top recipients of funding from the National Institutes of Health, with $479.3 million awarded in the 2011 fiscal year.
The University of Pennsylvania Health System's patient care facilities include: The Hospital of the University of Pennsylvania -- recognized as one of the nation's top "Honor Roll" hospitals by U.S. News & World Report; Penn Presbyterian Medical Center; and Pennsylvania Hospital — the nation's first hospital, founded in 1751. Penn Medicine also includes additional patient care facilities and services throughout the Philadelphia region.
Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2011, Penn Medicine provided $854 million to benefit our community.
Journal
Neurology