Clinical Validation of Cognivue® - A Computerized Alternative to the Montreal Cognitive Assessment Test

*Fred Ma
Department Of Neurology, Cognivue Inc., New York, United States

*Corresponding Author:
Fred Ma
Department Of Neurology, Cognivue Inc., New York, United States

Published on: 2021-06-21


Aims: To determine the utility of Cognivue® compared to the MoCA for reliably assessing cognitive impairment (CI).

Methods: Adults ≥55y completed two testing sessions 1-2 weeks apart during which both Cognivue® and MoCA were conducted. Correlation analyses were performed for overall scores on each neuropsychological test and retest reliability was assessed via regression analyses.

Results: 100 participants completed the testing sessions. A statistically significant positive correlation between overall scores on Cognivue® and MoCA was found (r = 0.38; p<0.001). Test-retest reliability was greater for Cognivue® than MoCA for participants initially classified as having no CI (87.3% vs. 73.1%). Regression analyses of test-retest reliability revealed a tighter and more linear pattern for Cognivue® than MoCA, however a statistically significant regression fit for both was demonstrated (Cognivue®: R2 = 0.439, r = 0.663; MoCA: R2 = 0.378, r = 0.615).

Conclusions: Cognivue® demonstrated comparable reliability to MoCA, thus providing an efficient, easy-to-use alternative for assessing CI.


Cognitive Assessment, Dementia, Memory, Motor Control, Cognivue, MoCA


Current estimates of cognitive impairment (CI) prevalence vary from 5-8% for dementia [1] to as high as 42% for mild cognitive impairment (MCI) [2,3]. In late 2020, the World Health Organization (WHO) released updated global health estimates of cause-specific mortality with "Alzheimer's disease and other dementias" ranked as the 7th leading cause of death globally [4]. In the US specifically, it is now the 2nd leading cause of death overall with an incidence of 87.3 per 100,000 people [4].

Though age is the strongest risk factor [3], several other issues have also been associated with an increased incidence of CI and include, but are not limited to, traumatic brain injury (TBI) [5,6], repetitive head impacts [5], post-traumatic stress disorder (PTSD) [7], major depressive disorder (MDD) [8,9], and hearing issues [10].

Different risk factors for CI have been associated with impairments to different cognitive domains. For example, repetitive head injury is associated with deficits in working memory [5], patients with depressive symptoms show reductions in information processing speed [11], and PTSD is associated with impairments to learning and memory [12], information processing [13], and executive function [13].

Early identification and routine assessment of CI can facilitate discussion between the patient and clinician regarding potential interventions (eg, specific attention to modifiable risk factors for CI progression), providing greater opportunity to improve patient outcomes. Additionally, increasing system-wide use of a faster yet more objective method of multi-domain cognitive assessment would enhance the efficiency of neurocognitive testing in clinical practice and be of particular value in large healthcare systems such as the Veteran's Health Administration (VHA) where a 2017 survey among clinicians (n=123) revealed that 215 different instruments had been used in a single month [14].

The more traditional cognitive assessment methods relying on paper-and-pencil and/or face-to-face interaction have become less suitable for current practice. In addition to the numerous and well-documented downsides to instruments like the Montreal Cognitive Assessment (MoCA), the St. Louis University Mental Status (SLUMS) examination, and the Mini-Mental Status Examination (MMSE) such as time required for administration [3,15, and 16], mediocre sensitivity and retest reliability [17-19], subjective scoring [20,21], and various bias issues [22,23], these tools fall short in meeting the current moment where a shorter duration of direct contact between the clinician and patient might be preferable. Furthermore, the effort to improve access to care has created a substantial need for alternative methods to assess cognition in patients, however many of the current adaptive solutions for remote testing, either via video-link, telephone, or other means, introduce additional challenges-the most concerning being an inability to fully assess certain cognitive domains [24-27].

Cognivue® is an easy-to-use, automated platform for evaluating and tracking CI. It provides both the patient and clinician with specific feedback for multiple cognitive domains within 10 minutes. Initial research for Cognivue® assessed neural mechanisms of different functional impairments and established a foundation for subsequent pivotal trials examining its psychometric properties and utility as a tool for assessing degree of CI. The reliability of Cognivue® has been established and the agreement between Cognivue® and SLUMS scoring relative to CI impairment classifications has been validated [21], leading to Cognivue® being granted FDA-clearance in 2015 for use as an adjunctive tool to assist in assessing for CI [28]. 

While trials directly comparing Cognivue® and the MoCA have not been previously published, studies demonstrating good agreement between both Cognivue® and SLUMS scores [21] as well as between SLUMS and MoCA scores [29] are available and provide a reasonable extrapolation of the relationship between Cognivue® and MoCA scoring.

The objective of the current study was to clinically validate Cognivue® via comparison of overall scoring relative to the MoCA test. Additionally, this study sought to assess differences in overall cognitive assessment to determine the test-retest reliability between Cognivue® and the MoCA.

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