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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Canada1 site
  • MoCA Clinic and Institute

    Greenfield Park, Quebec, J4V 2J2

Other trials in Canada

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 groups in NCT05879562
Study groupRoleWhat they receive
MoCA-Xpresso firstExperimentalParticipants in the study will complete the MoCA-Xpresso test before the digital-MoCA classic test.
Receives: Diagnostic Test: MoCA-Xpresso
MoCA-Xpresso secondExperimentalParticipants 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.

  1. 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)
  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.

  1. First posted30 May 2023
  2. Study start1 Oct 2022
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

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)
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

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.

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