DRAFT — PENDING QUALITY ASSURANCE & REGULATORY REVIEW — NOT FOR DISTRIBUTION
MoCA Solo
Instructions for Use — Self-Administered Cognitive Assessment Application
Document
Instructions for Use (IFU), English
Product
MoCA Solo application (iOS, Android, Web)
Document version
0.1 (draft)
Date of issue
2026-07-15
Manufacturer
Test MoCA Inc., Greenfield Park, Québec, Canada
Caution — Investigational Device. Limited by Federal (or United States) law to investigational use.
1. Product description
MoCA Solo is a self-administered digital cognitive assessment application. A virtual
avatar guides you step by step through a series of short cognitive tasks. Depending on the
task, you respond by speaking, drawing on the screen, or tapping the screen. Your responses
(including voice recordings and digital drawings) are securely transmitted for scoring.
MoCA Solo is available as a mobile application for iOS and Android tablets and as a web
application for supported browsers.
2. Intended use and intended users
MoCA Solo is intended to be used as a cognitive screening aid within research studies, under
the direction of a healthcare professional or study coordinator. It is completed independently
by the participant after setup by study staff.
MoCA Solo does not provide a medical diagnosis. Results must be reviewed and
interpreted by a qualified healthcare professional. If you have concerns about your cognitive
health, contact your healthcare provider.
3. Requirements before you start
A Study ID and Participant ID provided by your study coordinator or healthcare professional.
A stable internet connection for the full duration of the assessment.
A device with a working microphone and speakers (or the device's built-in audio). You will be asked to grant microphone permission.
At least 200 MB of free storage on the device.
A quiet, well-lit room where you will not be interrupted. Background noise can affect voice-based tasks.
If you normally use glasses or hearing aids, wear them during the assessment.
Approximately 20–30 minutes of uninterrupted time.
4. Starting the assessment
Open the app installed on your device, or open the web link provided by your study coordinator in a supported browser.
Review the Terms of Use. Read the "MoCA Solo Terms of Use" screen. Your test responses, voice recordings, and digital drawings will be collected as described. Select Agree to continue, or Decline to exit.
Enter your study credentials. Type the Study ID and Participant ID exactly as they were given to you, then press NEXT. If you see "Please enter a valid study and participant ID", check the spelling with your study coordinator.
Demographics (if requested). Depending on the study, you may be asked to provide demographic information (for example sex, year of birth, first language, education). Complete the fields and press SUBMIT, or press SKIP if allowed by your study.
Choose your language. Select the assessment language from the available options.
Choose your guide. Select the virtual avatar who will guide you, then start the assessment.
Grant microphone access when the device asks. The assessment cannot record your spoken answers without it.
Check your audio. Follow the on-screen prompt to confirm you can hear the avatar clearly before proceeding.
5. During the assessment
The avatar explains each task before you perform it. Listen to the full instruction.
Press REPEAT INSTRUCTIONS if you want to hear an instruction again.
Press NEXT when you are ready to move to the next step.
For speaking tasks, answer aloud in a clear voice after the prompt.
For drawing tasks, draw directly on the screen with your finger or stylus. Use the Pencil and Eraser tools to correct your drawing if needed.
For tapping tasks, tap the screen as instructed.
Some tasks have a time limit. If time runs out, the app automatically continues to the next task — this is normal.
Do not close the app, switch to another app, or lock the device during the assessment.
Between some steps the app may briefly display a waiting screen while your responses are processed. Do not exit; the assessment will continue automatically.
6. Finishing the assessment
When all tasks are complete, a "THANK YOU" screen confirms that you have finished.
If the message "Some task results are still being uploaded" is shown, keep the device connected to the internet until the upload completes.
If you were given the device by a healthcare professional, return it to them as instructed on screen.
Results are made available to your study team / healthcare professional; the app does not show you a score unless your study is configured to do so.
7. Troubleshooting
Message / problem
What it means
What to do
"No internet connection."
The device is offline.
Reconnect to Wi-Fi or mobile data. The assessment resumes when the connection returns.
"The app is currently unavailable. Please try again shortly."
The service is temporarily unreachable.
Wait a few minutes and try again. If it persists, contact support.
"The app is in a scheduled maintenance window…"
Planned maintenance is in progress.
Try again after the end time shown in the message.
"Microphone Permission Denied"
The app is not allowed to use the microphone.
Enable microphone access for MoCA Solo in your device settings (or browser site permissions), then reopen the app.
"The microphone is not capturing audio."
No sound is being recorded.
Check that the microphone is not covered or muted, move to a quieter spot, and speak toward the device.
"There is not enough space on the device…"
The device has insufficient free storage.
Free up at least 200 MB of storage, then try again.
"Your app needs to be updated."
The installed app version is out of date.
Update MoCA Solo from the app store (or ask your study coordinator), then relaunch it.
"A SOLO assessment with that Study ID and Participant ID already exists."
An assessment was already started with these credentials.
Continue only if instructed to by your study coordinator; otherwise verify your IDs with them.
8. Warnings and precautions
MoCA Solo is an investigational device and is limited by Federal (or United States) law to investigational use.
MoCA Solo is a screening aid, not a diagnostic tool. Do not make medical decisions based on the app on your own.
Complete the assessment in one sitting, without help from others, unless your study coordinator instructs otherwise.
Use the app only with the credentials provided to you; do not share them.
An unstable internet connection, loud environment, or interrupted session can affect the quality of the assessment.