Barriers and solutions to Alzheimer's disease clinical trial participation for Black Americans

Savold, Jordan; Cole, Michele; Thorpe, Roland J.

doi:10.1002/trc2.12402

Cited by 4 publications

(1 citation statement)

References 47 publications

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“… 5 , 6 , 7 Understanding the social and structural determinants of health in ADRD research and intervening requires representation within clinical trials and interventions that are accessible. 8 With recent advances in pharmacological interventions in ADRD, these lessons have gone unheeded. 7 As the field of ADRD research looks to new pharmacological interventions as well as potentially modifiable risk factors, centering health equity is essential to ensuring that the science represents those most affected by ADRDs and the solutions do not exacerbate existing disparities.…”

Section: Introductionmentioning

confidence: 99%

Hearing loss and cognitive decline: Prioritizing equity in a world in which hearing health matters

Nieman,

Thorpe,

2024

A&D Transl Res & Clin Interv

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Alzheimer's disease and related dementias (ADRDs) and age‐related hearing loss are the intersection of two major public health challenges. With age as the primary risk factor for both disease processes, the burden of ADRDs and age‐related hearing loss is growing, and each field maintains significant barriers to broadscale identification and management that is affordable and accessible. With the disproportionate burden of ADRDs among racial and ethnic minority older adults and existing disparities within hearing care, both areas face challenges in achieving equitable access and outcomes across diverse populations. The publication of the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) trial in July 2023 marked a significant moment in the fields of brain and hearing health. The ACHIEVE trial was the first randomized controlled trial to examine whether providing hearing intervention, specifically provision of hearing aids, compared to an education control, would reduce cognitive changes over 3 years. The participants most at risk for cognitive decline, with lower education, lower income, more likely to identify as Black, and have more cardiovascular risk factors, were the participants who benefited most from the hearing intervention and are also the least likely to be represented in research and the least likely to obtain hearing care. With growing evidence of the interconnection between cognitive and sensory health, we have an opportunity to prioritize equity, from purposeful inclusion of diverse participants in trials to influencing the emerging market of over‐the‐counter hearing aids to supporting expanded models of hearing care that reach those who have traditionally gone unserved. No longer can hearing go unrecognized by clinicians, researchers, and advocates for brain health. At the same time, the fields of brain and hearing health must center equity if we are going to meet the needs of diverse older adults in a world in which hearing health matters.

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Section: Introductionmentioning

confidence: 99%

Hearing loss and cognitive decline: Prioritizing equity in a world in which hearing health matters

Nieman,

Thorpe,

2024

A&D Transl Res & Clin Interv

Self Cite

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Underrepresented and Underserved Populations in Neurological Research

Windon,

Jackson,

Aguirre

et al. 2024

Semin Neurol

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Underserved and underrepresented populations have historically been excluded from neurological research. This lack of representation has implications for translation of research findings into clinical practice given the impact of social determinants of health on neurological disease risk, progression, and outcomes. Lack of inclusion in research is driven by individual-, investigator-, and study-level barriers as well as larger systemic injustices (e.g., structural racism, discriminatory practices). Although strategies to increase inclusion of underserved and underrepresented populations have been put forth, numerous questions remain about the most effective methodology. In this article, we highlight inclusivity patterns and gaps among the most common neurological conditions and propose best practices informed by our own experiences in engagement of local community organizations and collaboration efforts to increase underserved and underrepresented population participation in neurological research.

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A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial

Mace,

Law,

Cohen

et al. 2024

JMIR Res Protoc

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Background Lifestyle behavior change and mindfulness have direct and synergistic effects on cognitive functioning and may prevent Alzheimer disease and Alzheimer disease–related dementias (AD/ADRD). We are iteratively developing and testing My Healthy Brain (MHB), the first mindfulness-based lifestyle group program targeting AD/ADRD risk factors in older adults with subjective cognitive decline. Our pilot studies (National Institutes of Health [NIH] stage 1A) have shown that MHB is feasible, acceptable, and associated with improvement in lifestyle behavior and cognitive outcomes. Objective We will compare the feasibility of MHB versus an education control (health enhancement program [HEP]) in 50 older adults (aged ≥60 y) with subjective cognitive decline and AD/ADRD risk factors. In an NIH stage 1B randomized controlled trial (RCT), we will evaluate feasibility benchmarks, improvements in cognitive and lifestyle outcomes, and engagement of hypothesized mechanisms. Methods We are recruiting through clinics, flyers, web-based research platforms, and community partnerships. Participants are randomized to MHB or the HEP, both delivered in telehealth groups over 8 weeks. MHB participants learn behavior modification and mindfulness skills to achieve individualized lifestyle goals. HEP participants receive lifestyle education and group support. Assessments are repeated after the intervention and at a 6-month follow-up. Our primary outcomes are feasibility, acceptability, appropriateness, credibility, satisfaction, and fidelity benchmarks. The secondary outcomes are cognitive function and lifestyle (physical activity, sleep, nutrition, alcohol and tobacco use, and mental and social activity) behaviors. Data analyses will include the proportion of MHB and HEP participants who meet each benchmark (primary outcome) and paired samples 2-tailed t tests, Cohen d effect sizes, and the minimal clinically important difference for each measure (secondary outcomes). Results Recruitment began in January 2024. We received 225 inquiries. Of these 225 individuals, 40 (17.8%) were eligible. Of the 40 eligible participants, 21 (52.5%) were enrolled in 2 group cohorts, 17 (42.5%) were on hold for future group cohorts, and 2 (5%) withdrew before enrollment. All participants have completed before the intervention assessments. All cohort 1 participants (9/21, 43%) have completed either MHB or the HEP (≥6 of 8 sessions) and after the intervention assessments. The intervention for cohort 2 (12/21, 57%) is ongoing. Adherence rates for the Garmin Vivosmart 5 (128/147, 87.1% weeks) and daily surveys (105/122, 86.1% weeks) are high. No enrolled participants have dropped out. Enrollment is projected to be completed by December 2024. Conclusions The RCT will inform the development of a larger efficacy RCT (NIH stage 2) of MHB versus the HEP in a more diverse sample of older adults, testing mechanisms of improvements through theoretically driven mediators and moderators. The integration of mindfulness with lifestyle behavior change in MHB has the potential to be an effective and sustainable approach for increasing the uptake of AD/ADRD risk reduction strategies among older adults. Trial Registration ClinicalTrials.gov NCT05934136; https://www.clinicaltrials.gov/study/NCT05934136 International Registered Report Identifier (IRRID) DERR1-10.2196/64149

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Barriers and solutions to Alzheimer's disease clinical trial participation for Black Americans

Cited by 4 publications

References 47 publications

Hearing loss and cognitive decline: Prioritizing equity in a world in which hearing health matters

Hearing loss and cognitive decline: Prioritizing equity in a world in which hearing health matters

Underrepresented and Underserved Populations in Neurological Research

A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial

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