Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
Cognitive screening biases in a secondary prevention Alzheimer's disease clinical trial.
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Sai Isha, Grill Joshua D, Younes Kyan, Winer Joseph R, Cody Karly A, Sperling Reisa, Mormino Elizabeth C, Young Christina B
Аннотация
INTRODUCTION: Alzheimer's disease (AD) prevention trials have multiple steps to identify cognitively unimpaired individuals with AD biomarker evidence. Cognitive/functional screening tests may be biased in ethnoracial minorities, impacting trial eligibility.
METHODS: A total of 6669 participants screened for the Anti-Amyloid Treatment in Asymptomatic Alzheimer's (A4) study were grouped by ethnoracial background and testing language. Ethnoracial/language differences in ineligibility reason, cognitive/functional test performance, and amyloid positivity rates were examined.
RESULTS: Ethnoracial minorities were least likely to meet eligibility criteria. Patterns of incorrect Mini-Mental State Examination items and impaired Clinical Dementia Rating functional domains differed between ethnoracial/language groups, suggesting potential test biases. The Free and Cued Selective Reminding Test yielded more similar exclusion rates across groups than Logical Memory. Cognitive/functional screening biases may impact subsequent biomarker screening as amyloid positivity rates were lowest in ethnoracial minorities.
DISCUSSION: Biases in cognitive/functional screening tests may be contributing to disproportionate exclusion of ethnoracial minorities in AD clinical trials.
METHODS: A total of 6669 participants screened for the Anti-Amyloid Treatment in Asymptomatic Alzheimer's (A4) study were grouped by ethnoracial background and testing language. Ethnoracial/language differences in ineligibility reason, cognitive/functional test performance, and amyloid positivity rates were examined.
RESULTS: Ethnoracial minorities were least likely to meet eligibility criteria. Patterns of incorrect Mini-Mental State Examination items and impaired Clinical Dementia Rating functional domains differed between ethnoracial/language groups, suggesting potential test biases. The Free and Cued Selective Reminding Test yielded more similar exclusion rates across groups than Logical Memory. Cognitive/functional screening biases may impact subsequent biomarker screening as amyloid positivity rates were lowest in ethnoracial minorities.
DISCUSSION: Biases in cognitive/functional screening tests may be contributing to disproportionate exclusion of ethnoracial minorities in AD clinical trials.