MoCA Solo

MoCA Solo – Investigational Cognitive Assessment App MoCA Solo is an investigational digital tool developed by MoCA Test Inc. (MoCA Cognition) to support the clinical validation of an automated version of the Montreal Cognitive Assessment (MoCA). It is intended for use exclusively within IRB-approved clinical studies conducted under the supervision of qualified researchers. MoCA Solo is not available to the general public and is not intended for diagnosis or treatment. MoCA Solo digitizes the well-established MoCA test and introduces AI-assisted automated administration and scoring capabilities to enable consistent, standardized cognitive testing. The app is used on MoCA-provided tablet devices during research sessions with adult participants using blinded identification. Key Features and Functionality Digital Cognitive Assessment: Presents an electronic version of the MoCA test, a widely used cognitive screening tool assessing domains such as attention, memory, language, visuospatial skills, and executive function. Automated Administration: Participants are guided through the assessment by the app interface. Instructions are displayed or read aloud, and responses are collected digitally. Voice and Drawing Capture: Participants provide verbal answers to certain items, which are recorded securely for analysis using speech-recognition algorithms. Drawing tasks are completed directly on the tablet screen. AI-Based Scoring: Responses, voice inputs, and drawings are analyzed automatically by an AI model trained to produce objective, standardized scoring results. No manual scoring is performed within the app. Minimal Supervision Mode: The app is designed to be used with minimal supervision, allowing for consistent administration across sites while maintaining data quality and participant comfort. Secure Data Handling: Each session begins with entry of a Study ID and Participant ID (assigned by the research site). The app collects no personal identifiers. All data are encrypted and transmitted to secure study servers managed by MoCA Cognition or its contracted research partners. Research Integration: Completed assessments are linked to the study’s central database for further statistical analysis. Participants do not view their scores within the app; results are accessible only to authorized research staff and the study sponsor. Intended Use MoCA Solo is an investigational software application undergoing validation to confirm its performance against the paper-based MoCA test. It is intended only for use in controlled research settings by or under the supervision of licensed investigators. Upon successful validation, MoCA Solo will be classified as a Software as a Medical Device (SaMD) under the U.S. Food and Drug Administration’s Class II 510(k) exemption for cognitive assessment tools. Important Notes MoCA Solo is not a diagnostic tool and should not be used to make clinical decisions. Only participants enrolled in an approved study may use the app using blinded identifiers. The app does not display scores or feedback to participants. MoCA Solo collects coded data only (no names, emails, or identifying information). MoCA Test Inc. owns all rights in the MoCA test and digital adaptations. Developer: MoCA Test Inc. (MoCA Cognition) Website: www.mocacognition.com Email: [email protected] Category: Medical / Research Availability: Restricted to approved clinical sites and research participants Copyright © 2025 MoCA Test Inc. All rights reserved.