Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05879562 |
| Other study ID # |
MoCA Xpresso 01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
MoCA Clinic and Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
