Acceptable standards for clinic-based digital cognitive assessments: Recommendations from the Global CEO Initiative on Alzheimer's Disease.

The rising prevalence of mild cognitive impairment (MCI) and dementia, combined with persistent underdiagnosis, is driving an increased need for scalable cognitive assessment tools. Digital cognitive assessments (DCAs) offer a promising solution by addressing longstanding barriers to routine cognitive testing and diagnosis. However, variations in performance and intended use have created confusion about their clinical applications and utility. The Global CEO Initiative on Alzheimer's Disease convened a DCA Workgroup to define the preferred characteristics of DCAs to meet the needs of patients, health care providers, and regulators for three clinical contexts: (1) initial detection of cognitive impairment, (2) diagnostic support for MCI and dementia, and (3) characterization of cognitive profiles to support identifying etiology. In the near term, ensuring that DCAs meet or exceed the performance of non-digital tools is a priority. DCAs must be validated in the intended use population with well-characterized study samples and inclusive designs.