WHY IS THE STUDY PARTNER REQUIREMENT A BARRIER TO RECRUITMENT IN PRECLINICAL ALZHEIMER’S DISEASE TRIALS?

Abstract

Alzheimer's disease (AD) clinical trials, including preclinical trials that enroll cognitively unimpaired participants with biomarker evidence of AD, require co-enrollment of a participant and a study partner. We previously found that the study partner requirement is among the most important barriers to preclinical trial recruitment and that this barrier may be greater in trials that require biomarker disclosure compared to trials that do not. This study examines why the study partner requirement is a barrier to enrollment in preclinical trials. We are conducting a mixed methods in-person interview study with 200 cognitively unimpaired participants, ages 60 to 85, recruited from the University of California, Irvine Consent-to-Contact Registry. We review example preclinical AD trial consent forms and then ask open-ended and forced choice questions to elucidate attitudes toward participation, including assessment of positive and negative associations with the study partner requirement. We collect participant demographics and responses to the AD Knowledge Scale, Risk for AD Scale, and Research Attitudes Questionnaire. To elucidate the study partner barrier, we will use a proportional odds model regressing the ordinal level of agreement for a statement that the study partner requirement reduces probability of enrollment upon the reported level of agreement for varying statements related to the study partner (Table 1). We will perform content analyses for themes and correlations and summary analyses from quantitative survey items. We will present participant reported availability of a study partner for preclinical AD trials and the frequency of positive and negative associations with the study partner requirement. We will explore potential covariate relationships with study outcomes, including overall willingness to enroll in a preclinical AD trial.