The importance of study partners in Alzheimer’s clinical trials: An examination of the association between relationship type and protocol adherence

Abstract

AbstractBackgroundClinical trials for Alzheimer’s Dementia (AD) often require the involvement of a study partner, or knowledgeable informant, who serves as a data source for outcomes related to participants’ cognition and function. Study partners are essential to the success of AD trials (Largent et al., 2018). Although participants are not required to be related to their study partners, research has found that those with spouses as study partners were more likely to qualify for trials compared to those with adult children as their study partners (Grill et al., 2012). Furthermore, those whose spouses served as their study partners were less likely to drop out than those whose study partners were neither spouses nor adult children (Grill et al., 2013; Nuno et al., 2022). The current study further contributes to these prior works by examining how study partner type relates to participants’ compliance while enrolled in a clinical trial.MethodSecondary data analyses of a Phase 3 Early AD clinical trial will be conducted to examine how relationship type relates to adherence to protocol visits. Specifically, one way analysis of variance will be conducted to test the effect of relationship type (i.e., spouse, other family, other/non‐family) on adherence to protocol visit windows (i.e., number of out of window and missed visits). Correlation analyses also will be conducted to assess whether the average number of hours participants spend with their study partners per week is related to their compliance with study visits.ResultResults from the study will provide insight on study partner types that can facilitate greater adherence to protocol‐related procedures. Findings also may indicate whether the number of hours participants spend with their study partners are an important component of protocol adherence. Findings would have implications for study partner requirements of future AD trials.ConclusionThe current study will provide greater understanding of the role of study partners, and how different relationship types and number of hours spent with participants may relate to overall study compliance.