Research Attitudes Questionnaire scores predict Alzheimer’s disease clinical trial dropout

BackgroundMissing data are a notable problem in Alzheimer's disease clinical trials. One cause of missing data is participant dropout. The Research Attitudes Questionnaire is a 7-item instrument that measures an individual's attitudes toward biomedical research, with higher scores indicating more favorable attitudes. The objective of this study was to describe the performance of the Research Attitudes Questionnaire over time and to examine whether Research Attitudes Questionnaire scores predict study dropout and other participant behaviors that affect trial integrity.MethodsThe Research Attitudes Questionnaire was collected at baseline and weeks 26 and 52 from each member of 119 participant/study partner dyads enrolled in a Phase 2, randomized, double-blind, placebo-controlled mild-to-moderate Alzheimer's disease clinical trial. Within-subject longitudinal analyses examined change in Research Attitudes Questionnaire scores over time in each population. Logistic regression analyses that controlled for trial arm and clustering in trial sites were used to assess whether baseline Research Attitudes Questionnaire scores predicted trial completion, study medication compliance, and enrollment in optional substudies.ResultsParticipants and study partners endorsed statistically similar ratings on the Research Attitudes Questionnaire that were stable over time. Participants with baseline Research Attitudes Questionnaire scores above 28.5 were 4.7 (95% confidence interval = 1.01 to 21.95) times as likely to complete the trial compared to those with lower scores. Applying the same cutoff, baseline study partner Research Attitudes Questionnaire scores were similarly able to predict study completion (odds ratio = 4.2, 95% confidence interval = 1.71 to 10.32). Using a score cutoff of 27.5, higher participant Research Attitudes Questionnaire scores predicted study medication compliance (odds ratio = 5.85, 95% confidence interval = 1.34 to 25.54). No relationship was observed between Research Attitudes Questionnaire score and participation in optional substudies.ConclusionThis brief instrument that measures research attitudes may identify participants at risk for behaviors that cause missing data

The structural and social determinants of Alzheimer\u27s disease related dementias

INTRODUCTION: The projected growth of Alzheimer\u27s disease (AD) and AD-related dementia (ADRD) cases by midcentury has expanded the research field and impelled new lines of inquiry into structural and social determinants of health (S/SDOH) as fundamental drivers of disparities in AD/ADRD. METHODS: In this review, we employ Bronfenbrenner\u27s ecological systems theory as a framework to posit how S/SDOH impact AD/ADRD risk and outcomes. RESULTS: Bronfenbrenner defined the macrosystem as the realm of power (structural) systems that drive S/SDOH and that are the root cause of health disparities. These root causes have been discussed little to date in relation to AD/ADRD, and thus, macrosystem influences, such as racism, classism, sexism, and homophobia, are the emphasis in this paper. DISCUSSION: Under Bronfenbrenner\u27s macrosystem framework, we highlight key quantitative and qualitative studies linking S/SDOH with AD/ADRD, identify scientific gaps in the literature, and propose guidance for future research. HIGHLIGHTS: Ecological systems theory links structural/social determinants to AD/ADRD. Structural/social determinants accrue and interact over the life course to impact AD/ADRD. Macrosystem is made up of societal norms, beliefs, values, and practices (e.g., laws). Most macro-level determinants have been understudied in the AD/ADRD literature

Consideration of sex and gender in Alzheimer\u27s disease and related disorders from a global perspective

Sex or gender differences in the risk of Alzheimer\u27s disease and related dementias (ADRD) differ by world region, suggesting that there are potentially modifiable risk factors for intervention. However, few epidemiological or clinical ADRD studies examine sex differences; even fewer evaluate gender in the context of ADRD risk. The goals of this perspective are to: (1) provide definitions of gender, biologic sex, and sexual orientation. and the limitations of examining these as binary variables; (2) provide an overview of what is known with regard to sex and gender differences in the risk, prevention, and diagnosis of ADRD; and (3) discuss these sex and gender differences from a global, worldwide perspective. Identifying drivers of sex and gender differences in ADRD throughout the world is a first step in developing interventions unique to each geographical and sociocultural area to reduce these inequities and to ultimately reduce global ADRD risk. HIGHLIGHTS: The burden of dementia is unevenly distributed geographically and by sex and gender. Scientific advances in genetics and biomarkers challenge beliefs that sex is binary. Discrimination against women and sex and gender minority (SGM) populations contributes to cognitive decline. Sociocultural factors lead to gender inequities in Alzheimer\u27s disease and related dementias (ADRD) worldwide

Consideration of sex and gender in Alzheimer's disease and related disorders from a global perspective

Sex or gender differences in the risk of Alzheimer's disease and related dementias (ADRD) differ by world region, suggesting that there are potentially modifiable risk factors for intervention. However, few epidemiological or clinical ADRD studies examine sex differences; even fewer evaluate gender in the context of ADRD risk. The goals of this perspective are to: (1) provide definitions of gender, biologic sex, and sexual orientation. and the limitations of examining these as binary variables; (2) provide an overview of what is known with regard to sex and gender differences in the risk, prevention, and diagnosis of ADRD; and (3) discuss these sex and gender differences from a global, worldwide perspective. Identifying drivers of sex and gender differences in ADRD throughout the world is a first step in developing interventions unique to each geographical and sociocultural area to reduce these inequities and to ultimately reduce global ADRD risk. HIGHLIGHTS: The burden of dementia is unevenly distributed geographically and by sex and gender. Scientific advances in genetics and biomarkers challenge beliefs that sex is binary. Discrimination against women and sex and gender minority (SGM) populations contributes to cognitive decline. Sociocultural factors lead to gender inequities in Alzheimer's disease and related dementias (ADRD) worldwide

The formation of the advisory group on risk evaluation education for dementia

BackgroundWhen and how to communicate effectively the results of genetic and biomarker based prediction, detection, and quantification of the brain substrates of dementia involve important ethical and legal issues critical for precision medicine. The urgency of the issue has increased as People Living with Dementia (PLwD) and with Risk for Dementia (PwRD) can access direct to consumer genetic testing, amyloid targeting drugs, and clinical amyloid PET scans. To address the need for effective dissemination and consultation, an advisory group was convened that welcomes all interested members.MethodMembers attend two meetings monthly via phone/computer/WebEx. One meeting is a targeted working group that focuses on the following: 1. Symptomatic (PLwD), 2. Asymptomatic (PwRD), 3. Research, 4. Ethics/Healthcare Law, 5. Trainee/Mentorship. These discussion groups hear from and present to stakeholders (PLwD/PwRD/caregivers, professional organizations, companies) to solicit feedback on the efficacy of their efforts. Members also attend a monthly - all hands- meeting where they receive updates from other groups and hear presentations on emerging research and resources.ResultThe advisory group is composed of 104 members who represent advocacy/stakeholders (21%, e.g. professional organization representatives, (PLwD/PwRD/caregivers, FDA), academia (78%, e.g. university, funders, foundations), and healthcare law (1%). Professions include geneticists, genetic counsellors, researchers, clinicians, ethicists, and lawyers. Motivations for joining include improving communication in research and clinical contexts, mitigating potential negative impacts (e.g.emotional distress or discrimination), and protecting rights to know. Topics have included DTC genomics, the impact of APOE disclosure, genetics and personalized medicine, ecological momentary assessment of response to disclosure, and ethical issues in national and international research registries (EPAD). Activities included a survey on disclosure practices in NIA funded ADCs and collaborations with ADEAR. Stakeholders varied in concerns ranging from a need to protect patients from disclosure to a need to protect the right of access.ConclusionMembership is increasing and is engaging diverse specialties and stakeholders who provide education and consultation around communication and use of genetic and biomarkers related to dementia. The group structure and inclusion of members from multiple organizations supports open and free collaboration. Future efforts will be developing structured education for stakeholders and publications.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/163965/1/alz045562.pd