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Re: Clarifying comparative claims in digital cognitive assessment: Assessing concurrent validity in a shared cohort
Ali Jannati1,2, Sean Tobyne3, Alvaro Pascual-Leone3,4,5
1Linus Health, Inc, Boston, MA, USA. ajannati@linus.health.
Alzheimer'S Research & Therapy
|May 20, 2026
Summary
This study clarifies that the Digital Clock and Recall (DCR) and Cognivue Clarity assessments used the same participants, refuting claims of nonequivalent cohorts. Head-to-head comparisons support digital cognitive assessment standards.
Area of Science:
- Neuroscience
- Cognitive Science
- Biomedical Engineering
Background:
- Cognitive assessment tools are crucial for early detection of neurodegenerative diseases.
- Digital cognitive assessments offer novel approaches to evaluating cognitive function.
- Clarification is needed regarding the methodology of comparative studies in digital cognitive assessment.
Purpose of the Study:
- To address inaccuracies in a previous correspondence regarding the Bio-Hermes-001 study's participant cohort.
- To validate the methodology used for comparing the Digital Clock and Recall (DCR) and Cognivue Clarity assessments.
- To discuss the appropriate use of predictive models versus post hoc metrics in cognitive assessment research.
Main Methods:
- Employed a rigorous paired-sample design with 930 participants from the Bio-Hermes-001 study.
- Utilized harmonized datasets for both Digital Clock and Recall (DCR) and Cognivue Clarity assessments.
- Calculated performance metrics de novo to ensure accuracy and avoid reliance on outdated data.
Main Results:
- Confirmed that the analysis used a single cohort of 930 participants, refuting claims of "nonequivalent cohorts."
- Demonstrated that performance metrics were calculated from the harmonized study dataset, not outdated regulatory data.
- Explained that comparing a cross-validated predictive model (DCR) with a post hoc metric (CARM) from the same dataset would introduce bias.
Conclusions:
- The study's findings are based on a robust paired-sample design, ensuring methodological integrity.
- Head-to-head comparisons in diverse cohorts align with emerging standards for digital cognitive assessment.
- The research supports the Global CEO Initiative on Alzheimer's Disease (CEOi) recommendations for digital cognitive assessment.
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