Publications by authors named "Molina-Henry D"
Achieving Inclusion in Pharmacological Clinical Trials for Alzheimer's Disease.
Curr Top Behav Neurosci
December 2024
Participant recruitment and retention into randomized controlled trials (RCTs) is a growing and evolving science. It varies dramatically by discipline given the important and key choices that must be made based on the unique trial design considerations. In the field of Alzheimer's Disease (AD) therapeutics, recruitment goals, approaches, and strategies vary based on the disease stage of the target population which can range from asymptomatic adults with biomarker evidence of the disease to end-stage symptom management.
View Article and Find Full Text PDFBackground: Despite higher dementia prevalence in racial and ethnic minoritized communities, they are underrepresented in Alzheimer's disease clinical trials. Community-based recruitment strategies are believed to yield positive outcomes in various fields, such as cancer and cardiovascular clinical trials, but their outcomes in Alzheimer's disease and Related Dementias (AD/ADRD) require further study. In this systematic rapid review, we synthesized the available evidence on community-engaged recruitment strategies in enhancing participation in AD/ADRD clinical trials and observational study participation.
View Article and Find Full Text PDFArticle Synopsis
- * The paper emphasizes the importance of addressing disparities like ageism and stigma, especially for minoritized communities, while providing examples of how PPI can be integrated throughout the research process.
- * Recommendations for researchers include fostering collaborative relationships with communities, starting partnerships early, and ensuring that factors like choice, respect, and inclusion are prioritized.
Introduction: Metrics of a participant's socioeconomic status (SES) are not routinely collected or standardized in clinical trials. This omission limits the ability to evaluate the generalizability of trial results and restricts clinicians from confidently interpreting the efficacy of new treatments across important sub-populations.
Methods: We adapted an SES measure of social disparity; the Hollingshead Two Factor Index of Social Position, which combines education and occupation into a single metric.
Background: Participant discontinuation from study treatment in a clinical trial can leave a trial underpowered, produce bias in statistical analysis, and limit interpretability of study results. Retaining participants in clinical trials for the full study duration is therefore as important as participant recruitment.
Objective: This analysis aims to identify associations of pre-randomization characteristics of participants with premature discontinuation during the blinded phase of the Anti-Amyloid treatment in Asymptomatic AD (A4) Study.
Background: Individuals from diverse racial and ethnic groups are severely underrepresented in Alzheimer's disease trials in part due to disproportionate biomarker ineligibility. Evidence from recent studies support plasma phosphorylated tau 217 (P-tau217) as an early marker for brain Aβ pathology and a reliable marker in predicting elevated brain amyloid PET in cognitively unimpaired adults.
Objectives: To examine whether the relationship between P-tau217 and 18-F florbetapir PET standard uptake value ratios (SUVR) is influenced by race and ethnicity in the Anti-Amyloid treatment in Asymptomatic Alzheimer's disease (A4) preclinical AD studies.
Background: Blood-based AD biomarkers such as plasma P-tau217 are increasingly used in clinical trials as a screening tool.
Objectives: To assess the utility of an electrochemiluminescence (ECL) immunoassay in predicting brain amyloid PET status in cognitively unimpaired individuals.
Setting: Plasma samples collected at baseline, week 12, and week 240 or endpoint originated from the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) trial and the companion Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) study.
Introduction: In trials of amyloid-lowering drugs for Alzheimer's disease (AD), differential eligibility may contribute to under-inclusion of racial and ethnic underrepresented groups. We examined plasma amyloid beta 42/40 and positron emission tomography (PET) amyloid eligibility for the ongoing AHEAD Study preclinical AD program (NCT04468659).
Methods: Univariate logistic regression models were used to examine group differences in plasma and PET amyloid screening eligibility.
Background: Emerging evidence suggests that a number of factors can influence blood-based biomarker levels for Alzheimer's disease (AD) and Alzheimer's related dementias (ADRD). We examined the associations that demographic and clinical characteristics have with AD/ADRD blood-based biomarker levels in an observational continuation of a clinical trial cohort of older individuals with type 2 diabetes and overweight or obesity.
Methods: Participants aged 45-76 years were randomized to a 10-year Intensive Lifestyle Intervention (ILI) or a diabetes support and education (DSE) condition.
Article Synopsis
- The study assessed eligibility rates for participation in Alzheimer's disease (AD) clinical trials among different racial and ethnic groups across the U.S.
- Out of 10,804 screened participants, there was a significant underrepresentation of Hispanic and Black participants, with higher chances of ineligibility based on amyloid biomarker criteria compared to their non-Hispanic White counterparts.
- The findings suggest that varying eligibility criteria may contribute to the underrepresentation of certain minored groups in early AD trials, which could impact treatment outcomes and research efficacy.
Background: Daytime sleepiness is common in older adults and may result from poor nighttime sleep due to sleep disordered breathing, fragmented sleep, or other sleep disorders. Daytime sleepiness may be associated with cognition in older adults.
Objectives: We investigated the association between self-reported daytime sleepiness and cognitive function in the Look AHEAD clinical trial.