HOW DO PEOPLE WITH MILD COGNITIVE IMPAIRMENT AND THEIR FAMILY MEMBERS DECIDE WHETHER TO ENROLL IN PRODROMAL ALZHEIMER’S DISEASE CLINICAL TRIALS?

Abstract

In an effort to intervene earlier in disease, Alzheimer's disease (AD) clinical trials are increasingly enrolling pre-dementia populations. This includes patients meeting criteria for mild cognitive impairment (MCI), defined as memory and other cognitive problems not sufficient to impair activities of daily living. More recently, trials have enrolled MCI patients who demonstrate AD biomarkers, termed prodromal AD. Little is known about how MCI patients and their family members decide whether to participate in trials and whether this decision-making process differs for prodromal AD trials and MCI trials that do not involve biomarker testing. We will perform separate in-person interviews with 25 MCI patient participants and their study partners, recruited from the UC Irvine AD Research Center longitudinal study. We will examine (1) how MCI patients and their study partners choose whether to enroll in clinical trials and (2) potential interactions among biomarker testing, risk tolerance, and trial decision-making. Participants will be interviewed about enrollment decisions and rate their willingness to participate in six trial vignettes, including three MCI trials (no biomarker inclusion criteria) and three prodromal AD trials (with amyloid imaging criteria), with varying levels of risk (low, medium, high). This study will provide critical insight to how MCI dyads approach clinical trial enrollment decisions. We will elucidate reasons MCI patients and their family members choose to enroll in clinical trials and whether this differs for trials that involve biomarker testing. We will examine the extent to which family members participate in the decision-making process. Finally, we will explore the impact of biomarker testing on risk tolerance and trial decisions. To enroll in prodromal AD trials, MCI patients must undergo AD biomarker testing. Biomarker testing may carry risk of stigma for MCI patients and deter enrollment. Alternatively, it may provide information that reduces anxiety related to diagnostic ambiguity and incentivize trial participation. Our data may inform trial design and conduct that ensure the safety of participants, hasten translational science, and maximize community trust toward research.