Improving Recruitment to Prodromal Alzheimer’s Disease Clinical Trials

The single greatest barrier to advances in Alzheimer’s disease (AD) treatment is poor recruitment to clinical trials of promising therapies. Most of these clinical trials now enroll patients with mild cognitive impairment (MCI), which in many cases may be a “prodromal” form of AD that exists before full-blown dementia develops. This project will identify the challenges to enrolling these patients in clinical trials and identify methods to improve recruitment to these critical studies.

The goal of this project is to better understand how patients diagnosed with mild cognitive impairment (MCI) and their families approach decisions about biomarker testing and clinical trial participation, and whether these decisions intersect or interact. We will interview people who have received a diagnosis of MCI and their family members to better understand their reactions to the diagnosis and how they approach two major decisions: 1) whether to undergo biomarker testing for Alzheimer’s disease, and 2) whether to participate in clinical trials of investigational therapies. Because clinical trials in people with MCI generally struggle to complete enrollment, we will also investigate incentives that might increase rates of participation. To date, few studies of decision making have focused on people with MCI, which in many cases may be a “prodromal” form of AD that exists before full-blown dementia develops. More and more clinical trials focus on MCI as a population. Better understanding of these issues and improved methods of recruitment are critically needed. This proposal will provide important information to guide efforts to improve recruitment to these studies, with the overarching goal of hastening advances in AD treatments and cures.