Cognitive ImpairmentMoCANCT05879562
Validation of a Digital Self-Administered Cognitive Screening Tool: MoCA-XpressO
A study testing MoCA-Xpresso in people with Cognitive Impairment and Cognitive Change, run by MoCA Clinic and Institute at 1 site in Canada.
Trial summary
The investigators conducted a validation study for the Montreal Cognitive Assessment (MoCA)-XpressO compared to the digital-MoCA test (version 8.1) as the gold standard. Participants were recruited from the MoCA clinic and a family practice. Ethics approval was received, and all participants provided informed consent. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Cognitive Change, Cognitive Deficit
- What is being tested?
- MoCA-Xpresso
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 years and over
- All gender inclusive
- All sex inclusive
- Fluent in English or in French
- Minimum 6 years of formal education
- Minimum total score of 11/30 on MoCA test
Who cannot join
- Age younger than 50 years
- Less than 6 years of formal schooling
- Total score on MoCA test less than 11/30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Montreal Cognitive Assessment (MoCA) XpressO: Validation of a Digital Self-administered Cognitive Pre-screening Tool for the General Adult Population
The investigators conducted a validation study for the Montreal Cognitive Assessment (MoCA)-XpressO compared to the digital-MoCA test (version 8.1) as the gold standard. Participants were recruited from the MoCA clinic and a family practice. Ethics approval was received, and all participants provided informed consent. A crossover study design was applied to the MoCA-XpressO and the digital-MoCA test; participants were randomized for the order of administration. The investigators only recruited participants who did not complete a MoCA test during the 3 months prior to the study. A logistic regression model was built, and the accuracy of the model was evaluated by the sensitivity, specificity, and area under the Receiver Operating Characteristic (ROC) curve.
Read the detailed description
Introduction:
The MoCA XpressO is a self-administered medical digital cognitive screening test. This test can help individuals assess whether they should have concerns regarding their cognition and should bring these concerns up to their physician. The test can be administered in an empty office in the clinic, or in the comfort of the patient's home.
The MoCA Classic test was first published in 2005 by Nasreddine et al. (The Montreal Cognitive Assessment, MoCA: A Brief Screening Tool for Mild Cognitive Impairment. J Am Geriatr Soc, 2005, 53:695-9.) The MoCA Classic test (version 8.2) is a one-page 30-point test administered in 10 minutes. The test and administration instructions are freely accessible at www.mocatest.org. The test is available in over 55 languages and dialects. The MoCA Classic assesses several cognitive domains. The short-term memory recall task (5 points) involves two learning trials of five nouns and delayed recall after approximately 5 minutes. Visuospatial abilities are assessed using a clock-drawing task (3 points) and a three-dimensional cube copy (1 point). Multiple aspects of executive functions are assessed using an alternation task adapted from the trail-making B task (1 point), a phonemic fluency task (1 point), and a two-item verbal abstraction task (2 points). Attention, concentration and working memory are evaluated using a target detection task (1 point), a serial subtraction task (3 points), and a forward and backward digit sequence task (1 point each). Language is assessed using a three-item confrontation naming task with low- familiarity animals (3 points), a two-item syntactically complex sentence repetition task (2 points), and the aforementioned fluency task. Finally, orientation to time and place is evaluated (6 points).
Study objectives/purpose:
This study seeks to validate the MoCA XpressO self-administered digital test compared to the MoCA Classic test for adults aged 50+. The study's goal is to confirm its performance as a viable screening tool to flag concerns regarding cognition in this population.
Objectives and Hypotheses:
Primary Objective: establish validity by comparing the MoCA XpressO vs. the digital MoCA Classic test.
Validity Outcome 1: Correlation between the total score of MoCA XpressO and the total score of the digital MoCA Classic test.
Hypothesis 1: There will be a significant correlation between the total scores of the MoCA XpressO and MoCA Classic test.
Secondary Objective: explore the users' experience of the MoCA XpressO test through subjective feedback from the participant.
Outcome 2: subjective feedback about user experience for participant (Likert Scale) Hypothesis 2: user experience will be rated high (>=4) on a Likert scale 1-5.
Additional exploratory measures/data:
Demographic information (age, level of education etc.); diagnosis; previous MMSE or MoCA score if available; frequency of technological use
Study Sample: the target number of participants is 100. Participants will be recruited from the MoCA Memory Clinic and Institute and the Cornwall family practice clinic. Participants in this study will consist of adults age 50 and over, with no restrictions to sex, gender, or ethnicity. There will be an equal number of participants with normal cognition, mild cognitive impairment, and mild AD. They must speak English or French and have at least 6 years of formal schooling.
Study locations: 2 clinical sites will recruit potentially eligible participants. (1) MoCA Clinic and Institute, Greenfield Park, Québec, Canada; and (2) Family Medicine Practice, Cornwall, Ontario, Canada
Randomization:
The order of administration of the MoCA XpressO and the digital MoCA Classic test will be determined randomly so that each test will have similar chances of being first, or second. The same rater will be performing the MoCA Classic test in each clinic participating in the validation study.
Blinding: The participants are blinded to the screening test that is being studied. The researcher doing the analysis will be blinded to the order of randomization.
- Being tested
- MoCA-Xpresso
- Keywords
- Cognitive screening, Cognition, Cognitive impairment, Cognitive decline, Self-assessment
- Medical subject headings
- Cognitive Dysfunction, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoCA-XpressoDiagnostic test
MoCA-Xpresso is a home-based, self-administered digital cognitive screening tool, based on a tablet device.
| Study group | Role | What they receive |
|---|---|---|
| MoCA-Xpresso first | Experimental | Participants in the study will complete the MoCA-Xpresso test before the digital-MoCA classic test. Receives: Diagnostic Test: MoCA-Xpresso |
| MoCA-Xpresso second | Experimental | Participants in the study will complete the digital-MoCA classic test before the MoCA-Xpresso test. Receives: Diagnostic Test: MoCA-Xpresso |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the MoCA XpressO and the Digital MoCA
Correlation between the total score of MoCA XpressO and the total score of the Digital MoCA Classic
Measured: up to 30 minutes (for completion of all intervention included in the study)
Secondary outcomes (1)
Correlation between scores of sub-tests on MoCA-XpressO and the Digital MoCA
Correlation between the scores of the sub-tests on MoCA XpressO and the scores of the sub-tests on the Digital MoCA Classic
Measured: up to 30 minutes (for completion of all interventions in the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Oct 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MoCA Clinic and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ziad Nasreddine, MD, Principal investigator, MoCA Clinic and Institute, 4896 Taschereau Blvd bureau 230, Greenfield Park, Quebec J4V 2J2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879562
- Sponsor's protocol ID
- MoCA Xpresso 01
- Acronym
- MoCA
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montreal Cognitive Assessment (MoCA) XpressO: Validation of a Digital Self-administered Cognitive Pre-screening Tool for the General Adult Population
- ClinicalTrials.gov ID
- NCT05879562
- Acronym / sponsor ID
- MoCA / MoCA Xpresso 01
- Keywords
- Cognitive screening, Cognition, Cognitive impairment, Cognitive decline, Self-assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MoCA Clinic and InstituteUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators conducted a validation study for the Montreal Cognitive Assessment (MoCA)-XpressO compared to the digital-MoCA test (version 8.1) as the gold standard. Participants were recruited from the MoCA clinic and a family practice. Ethics approval was received, and all participants provided informed consent. A crossover study design was applied to the MoCA-XpressO and the digital-MoCA test; participants were randomized for the order of administration. The investigators only recruited participants who did not complete a MoCA test during the 3 months prior to the study. A logistic regression model was built, and the accuracy of the model was evaluated by the sensitivity, specificity, and area under the Receiver Operating Characteristic (ROC) curve.
Detailed description
Introduction:
The MoCA XpressO is a self-administered medical digital cognitive screening test. This test can help individuals assess whether they should have concerns regarding their cognition and should bring these concerns up to their physician. The test can be administered in an empty office in the clinic, or in the comfort of the patient's home.
The MoCA Classic test was first published in 2005 by Nasreddine et al. (The Montreal Cognitive Assessment, MoCA: A Brief Screening Tool for Mild Cognitive Impairment. J Am Geriatr Soc, 2005, 53:695-9.) The MoCA Classic test (version 8.2) is a one-page 30-point test administered in 10 minutes. The test and administration instructions are freely accessible at www.mocatest.org. The test is available in over 55 languages and dialects. The MoCA Classic assesses several cognitive domains. The short-term memory recall task (5 points) involves two learning trials of five nouns and delayed recall after approximately 5 minutes. Visuospatial abilities are assessed using a clock-drawing task (3 points) and a three-dimensional cube copy (1 point). Multiple aspects of executive functions are assessed using an alternation task adapted from the trail-making B task (1 point), a phonemic fluency task (1 point), and a two-item verbal abstraction task (2 points). Attention, concentration and working memory are evaluated using a target detection task (1 point), a serial subtraction task (3 points), and a forward and backward digit sequence task (1 point each). Language is assessed using a three-item confrontation naming task with low- familiarity animals (3 points), a two-item syntactically complex sentence repetition task (2 points), and the aforementioned fluency task. Finally, orientation to time and place is evaluated (6 points).
Study objectives/purpose:
This study seeks to validate the MoCA XpressO self-administered digital test compared to the MoCA Classic test for adults aged 50+. The study's goal is to confirm its performance as a viable screening tool to flag concerns regarding cognition in this population.
Objectives and Hypotheses:
Primary Objective: establish validity by comparing the MoCA XpressO vs. the digital MoCA Classic test.
Validity Outcome 1: Correlation between the total score of MoCA XpressO and the total score of the digital MoCA Classic test.
Hypothesis 1: There will be a significant correlation between the total scores of the MoCA XpressO and MoCA Classic test.
Secondary Objective: explore the users' experience of the MoCA XpressO test through subjective feedback from the participant.
Outcome 2: subjective feedback about user experience for participant (Likert Scale) Hypothesis 2: user experience will be rated high (>=4) on a Likert scale 1-5.
Additional exploratory measures/data:
Demographic information (age, level of education etc.); diagnosis; previous MMSE or MoCA score if available; frequency of technological use
Study Sample: the target number of participants is 100. Participants will be recruited from the MoCA Memory Clinic and Institute and the Cornwall family practice clinic. Participants in this study will consist of adults age 50 and over, with no restrictions to sex, gender, or ethnicity. There will be an equal number of participants with normal cognition, mild cognitive impairment, and mild AD. They must speak English or French and have at least 6 years of formal schooling.
Study locations: 2 clinical sites will recruit potentially eligible participants. (1) MoCA Clinic and Institute, Greenfield Park, Québec, Canada; and (2) Family Medicine Practice, Cornwall, Ontario, Canada
Randomization:
The order of administration of the MoCA XpressO and the digital MoCA Classic test will be determined randomly so that each test will have similar chances of being first, or second. The same rater will be performing the MoCA Classic test in each clinic participating in the validation study.
Blinding: The participants are blinded to the screening test that is being studied. The researcher doing the analysis will be blinded to the order of randomization.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MoCA-Xpresso first | Experimental | Diagnostic Test: MoCA-XpressoParticipants in the study will complete the MoCA-Xpresso test before the digital-MoCA classic test. |
| MoCA-Xpresso second | Experimental | Diagnostic Test: MoCA-XpressoParticipants in the study will complete the digital-MoCA classic test before the MoCA-Xpresso test. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50 years and over
- All gender inclusive
- All sex inclusive
- Fluent in English or in French
- Minimum 6 years of formal education
Key exclusion criteria (3 listed)
- Age younger than 50 years
- Less than 6 years of formal schooling
- Total score on MoCA test less than 11/30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoCA-XpressoMoCA-Xpresso is a home-based, self-administered digital cognitive screening tool, based on a tablet device. | Diagnostic test | MoCA-Xpresso first, MoCA-Xpresso second |
Primary outcome
Correlation between the MoCA XpressO and the Digital MoCA
Time frame: up to 30 minutes (for completion of all intervention included in the study)
Correlation between the total score of MoCA XpressO and the total score of the Digital MoCA Classic
1 secondary outcome
Correlation between scores of sub-tests on MoCA-XpressO and the Digital MoCA
Time frame: up to 30 minutes (for completion of all interventions in the study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziad Nasreddine, MD principal investigator
MoCA Clinic and Institute, 4896 Taschereau Blvd bureau 230, Greenfield Park, Quebec J4V 2J2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoCA-Xpresso in people with Cognitive Impairment and Cognitive Change, run by MoCA Clinic and Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the MoCA XpressO and the Digital MoCA (time frame: up to 30 minutes (for completion of all intervention included in the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.