Evaluating digital cognitive tests for clinical use in Alzheimer's disease: A novel framework and scoping review
Harald Hampel, Yosuke Nakamura, Joanne Bell, Suzanne Hendrix, Miron Derchansky, Bruno B. Montezano, Luke E. Stoeckel, Stefan Teipel, Deanna R. Willis, Jeffrey L. Cummings, Bryan R. CobbAbstract
Mild cognitive impairment (MCI), a prodromal stage of Alzheimer's disease (AD), remains undiagnosed in > 90% of individuals, delaying access to timely evaluation and interventions. Self‐administered digital cognitive assessments (SA‐DCAs) offer scalable approaches for early detection, yet their real‐world validation and clinical readiness remain uncertain. We developed a use‐case–specific framework to evaluate SA‐DCAs intended for community and primary‐care MCI screening and applied it to a comprehensive scoping review of published evidence (2012‐2025). Among 79 identified SA‐DCAs, only four tools met predefined framework criteria across nine eligible studies. Common limitations included restricted population representativeness, inconsistent diagnostic performance reporting, limited biomarker anchoring, and reliance on prefiltered cohorts. Overall, the current evidence base is methodologically heterogeneous and incomplete for clinical deployment. The proposed framework characterizes requirements including anchoring strength, prevalence‐adjusted performance reporting, and representative sampling establishing a foundation for advancing robust real‐world evidence needed to translate SA‐DCAs from research to clinical practice.