In order to (1) safeguard ethical research principles such as justice, beneficence, and respect for persons (2) elucidate heterogeneity in causal mechanisms and responses to treatments and care (3) create robust AD/ADRD estimates based on adequately powered studies including determinants of population‐level differences (4) enhance research designs and methods that address health equity considerations (5) foster innovations in recruitment and retention and (6) understand cultural and sociopolitical nuances in decision‐making, help‐seeking, and daily practices that impact health disparities.įuture directions: A bold path forward is needed to ensure fairness and equity in AD/ADRD trials, close the racial and ethnic disparity gap in diagnosis, treatment and care, and optimize “good science.” Future efforts should account for structural barriers among all historically underrepresented people in AD/ADRD research and care.Įfforts to recruit Latino participants to clinical trials largely address individual‐ and family‐level factors, such as language, cultural beliefs, knowledge of aging and memory loss, limited awareness of research in general, and logistical considerations. The rationale to diversify cohorts and address AD/ADRD health disparities is predicated on sound and rigorous scientific principles, However, the NIH has systematically awarded scientists with federal grant funding resulting in limited evidence to inform AD/ADRD among the Latino population, as well as other racial and ethnic groups.
MICRO MESO AND MACRO LEVELS TRIAL
In fact, several National Institutes of Health (NIH) scientific initiatives and strategies highlight the importance of increasing the representativeness of trial samples, including funding innovations in science on diversity, recruitment, and retention in aging research. Several calls to action have underscored the societal and scientific imperatives for diversifying trial cohorts. The need to diversify AD/ADRD trial cohorts is critical and long overdue. The recent lecanemab drug trial indicated that 12.4% of study participants are Latino, thus showing improvement in recruitment target goals.Įarlier trials before the Clarity AD study are presented in Table 1 which includes rates for Latino sample representation across anti‐amyloid immunotherapy studies published within the last decade.Īs noted, Latino representation was either not reported, or ranged from zero to 3.3% before the lecanemab drug trial. In addition, Latino individuals accounted for 4.4% of participants in North American sites of the A4 Study, a phase 3 preclinical AD trial. For example, aducanamab-a FDA‐approved drug to treat AD/ADRD-was tested on a population comprised of only 3% Latino participants. Approvals of the Food and Drug Administration (FDA) of promising pharmacological treatments are key, yet clinical samples fall short of including Latino participants. Latino participants comprise a fraction of those actually enrolled despite accounting for 19% of the US population. Of the more than 200 clinical trials being conducted with over 70,000 US Americans, Have higher rates of neuropsychiatric symptoms,Īnd underutilize long‐term services and supports. Latino individuals live longer with AD/ADRD, Latino individuals have high rates of AD/ADRD (1.5 times greater than non‐Latino White persons) and are predicted to experience an 832% increase in rates by 2060. This paper addresses the Latino experience in the United States (US) with regards to a significant public health concern-the underrepresentation of the Latino population in AD/ADRD clinical trials-and issues a call to address the structural barriers that sustain such underrepresentation through the Micro‐Meso‐Macro Framework for Diversifying AD/ADRD Trial Recruitment.
For example, Latino and Black Americans have higher disease rates than non‐Latino White individuals, and they experience delayed diagnosis, poor quality treatment, and low access to evidence‐based, non‐pharmacological interventions. Although living with AD/ADRD is challenging for all people and families, current evidence highlights significant disparities. Latino individuals account for half (52%) of the nation's population growth, and are expected to increase from 62.5 million to 111 million people by 2060.Īlzheimer's disease and related dementias (AD/ADRD) are life‐threatening neurocognitive disorders that have garnered significant attention in recent decades in almost every sector of society.
(herein, Latino) persons are the nation's largest minoritized racial/ethnic group in the United States, comprising 19% of the population.
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