To view an abstract, select an author from the vertical list on the left.
2012 Grants - Grill
Barriers to Enrollment in Preclinical Alzheimer's Disease Clinical Trials
Joshua Grill, Ph.D.
University of California, Los Angeles
Los Angeles, California
2012 New Investigator Research Grant
Alzheimer's disease is a progressive disorder that has so far evaded an effective treatment. It is also a rapidly growing health problem that threatens to bankrupt healthcare systems worldwide. One problem with many Alzheimer's clinical trials is that they involve participants with clinically established dementia. At this stage of the disease process, Alzheimer's brain changes are widespread and possibly incurable. Future trials may need to focus on individuals whose disease has not progressed to an extent where drug therapy is unhelpful. New diagnostic criteria for "preclinical" Alzheimer's disease (meaning that key biological changes are underway in the body, but the disease has not yet caused any noticeable "clinical" symptoms such as memory loss) have recently been proposed by the U.S. National Institute on Aging and the Alzheimer's Association. These criteria will be used as a guide for selecting participants in upcoming trials. But the recruitment of at-risk people who are still cognitively healthy may be hampered by several barriers—including the need for expensive testing to determine whether these individuals have sufficient evidence of beta-amyloid or other dementia-related protein biomarkers.
Joshua Grill, Ph.D., and colleagues plan to conduct a study in which barriers to Alzheimer's clinical trial recruitment are identified and analyzed. They will interview a diverse group of 206 cognitively normal people aged 65 and older. Participants will be asked about their willingness to participate in one of two trial types: a trial that enrolls only individuals willing to learn whether or not they have biological evidence of Alzheimer's, or a trial that accepts all age-appropriate participants. The researchers will then compare participant willingness to enroll in each trial type. They will also conduct interviews with their participants to identify a variety of factors that either hinder or facilitate successful trial enrollment. Results of this work could provide important strategies for improving the design and recruitment of preclinical Alzheimer's trials.