UCLA study assesses prevalence of various types of study partners in Alzheimer's trials

Published on December 21, 2012 at 1:46 AM · No Comments

For Alzheimer's disease researchers who conduct clinical trials, enrolling enough patients to make a trial meaningful is always a challenge. To enroll a single patient in a study requires not one but two participants - the patient and what's known as a study partner. Study partners provide the patient with support and update researchers about the patient's progress.

A new UCLA study has assessed the prevalence of the various types of study partners in Alzheimer's clinical trials - a patient's spouse or "other" partners, like a patient's adult child - and has discovered that who the study partner is can actually impact the results of the trials and the interpretations of those results.

The study appears in the Dec. 19 online issue of the journal Neurology.

"The role of the study partner is vital to the success of Alzheimer's disease clinical trials," said the study's first author, Joshua D. Grill, an assistant professor of neurology at UCLA and a member of the UCLA Mary S. Easton Center for Alzheimer's Disease Research. "We count on them to ensure that the patient is taking their medications, drive them to appointments and, in general, report back how things are going."

In their analysis of 2,041 Alzheimer's patients who had participated in six clinical trials, Grill and his colleagues found that 67 percent of these patients had a spouse as their study partner. Yet in the general population, more than two-thirds of all unpaid Alzheimer's disease caregivers are patients' children, children-in-law or grandchildren, and half of unpaid caregivers are under the age of 50.

And importantly, the researchers said, as many as 90 percent of Alzheimer's sufferers don't have spouses.

"But two-thirds of clinical trial participants do have spouses," Grill said. "That confirms we are missing a huge population of people we are not enrolling. They're out there, and we need to do a better job of recruiting them in order to expedite study of promising drugs for Alzheimer's."

The team also found that, after controlling for confounding factors, the risk of dropout for the "other" study partner group - the group including adult children - was 70 percent higher than for the spouse study partner group.

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