Validity of gold-standard clinical outcome assessments in U.S. Latinx-Hispanic participants enrolled in Alzheimer's disease clinical trials: A literature review.

There is an urgency to achieve equitable representation of Latinx-Hispanic participants in Alzheimer's disease (AD) clinical trials. Valid instruments for these communities contribute to the generalizability of clinical trial outcomes. The aim of this study was to review articles reporting studies that conducted a thorough assessment of the validity and reliability of three gold-standard cognitive measures with U.S. Latinx-Hispanic communities. We reviewed validity/reliability studies of the Clinical Dementia Rating (CDR), Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog), and Repeatable Battery of the Assessment of Neuropsychological Scales (RBANS) among U.S. Latinx-Hispanic communities. Database searches included PubMed and PsycINFO. For the CDR, one study assessed validity and the other reliability. For the RBANS, one study evaluated the diagnostic accuracy, and another conducted an equating analysis. No studies addressed the validation/reliability of ADAS-Cog. Our literature review revealed limited studies examining the validity and reliability of the CDR, ADAS-Cog, and RBANS in U.S. Latinx-Hispanic communities. HIGHLIGHTS: Various government entities are mandating increased enrollment of the Latinx-Hispanic communities in AD clinical trials without considering the potential negative impact of study results when invalid COAs are used in underrepresented communities. Our investigation demonstrates three gold-standard COAs routinely used in AD clinical trials have mostly not been validated on the Latinx-Hispanic communities residing in the United States. We recommend specific actions to support the development of valid clinical outcome measures for the Latinx-Hispanic communities.