MoCA Solo

Medical

Free · Designed for iPad. Not verified for macOS.

iPad

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: privacy@mocacognition.com Category: Medical / Research Availability: Restricted to approved clinical sites and research participants Copyright © 2025 MoCA Test Inc. All rights reserved.

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The developer, MoCa Montreal, indicated that the app’s privacy practices may include handling of data as described below. For more information, see the developer’s privacy policy .

  • Data Linked to You

    The following data may be collected and linked to your identity:

    • Health & Fitness
    • User Content
    • Identifiers
    • Usage Data
    • Diagnostics

  • Data Not Linked to You

    The following data may be collected but it is not linked to your identity:

    • Contact Info

Privacy practices may vary, for example, based on the features you use or your age. Learn More

Accessibility

The developer has not yet indicated which accessibility features this app supports. Learn More

Information

Seller
Test MoCA Inc.
Size
49.4 MB
Category
Medical
Compatibility
Requires iPadOS 15.1 or later.
  • iPad
    Requires iPadOS 15.1 or later.
  • Mac
    Requires macOS 12.0 or later and a Mac with Apple M1 chip or later.
Languages
English
Age Rating
9+
Medical Device
Yes
  • MoCa Montreal indicated this app is a regulated medical device and complies with United States law.
  • The information below has not been verified by Apple.
  • FDA Owner/Operator Number
  • 10096077
  • Address
  • 4896 Boul Taschereau Bureau 230
    Greenfield Park Quebec J4V 2J2
    Canada
  • Phone Number
  • +1 438-522-5601
  • Email
  • info@mocacognition.com
  • Use Statement
  • MoCA Solo is a computerized cognitive assessment aid intended for use by or on the order of a licensed healthcare professional (HCP) to provide information regarding an individual's level of cognitive functioning. MoCA Solo is intended to assist healthcare professionals in identifying individuals who may benefit from further clinical evaluation.

    MoCA Solo automatically calculates scores by applying the Official MoCA Version 8.1 scoring rules and applies a calibration adjustment to derive the calibrated MoCA Solo score. Both the MoCA Solo total score and the calibrated MoCA Solo score are presented to the supervising licensed HCP for review and interpretation.

    The application does not identify the presence or absence of clinical diagnoses and is not intended as a stand-alone or adjunctive diagnostic device. Interpretation of results and all clinical decision-making remain the responsibility of the licensed HCP.
  • Safety Information
  • MoCA Solo is intended for use by, or on the order of, a licensed healthcare professional (HCP) and must be administered under the supervision of a licensed HCP or qualified clinic personnel.
    MoCA Solo is a computerized cognitive assessment aid. It does not identify the presence or absence of a clinical diagnosis and is not intended to diagnose, rule out, or confirm any disease or condition, including Alzheimer's disease or other dementias. It is not intended to be used as a stand-alone or adjunctive diagnostic device.
    Results generated by MoCA Solo must be interpreted by a licensed healthcare professional in the context of the individual's overall clinical presentation, medical history, and other relevant clinical information. All clinical interpretation and decision-making remain the responsibility of the licensed healthcare professional.
    MoCA Solo should not be used as a substitute for comprehensive clinical or neuropsychological evaluation when such evaluation is clinically indicated.
    Score validity may be affected by factors such as patient fatigue, medication effects, acute illness, anxiety, language barriers, environmental distractions, or significant visual, hearing, or motor impairments. Testing should be conducted in a quiet environment and in accordance with the Instructions for Use.
    MoCA Solo has been clinically validated in adults aged 50 years and older. Performance in individuals younger than 50 years of age has not been established.
    Users should read and follow the complete Instructions for Use before using the device.
  • Instructions for Use
  • Visit the developer site
Copyright
© MoCA Test Inc.
  • Privacy Policy

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