UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063187 |
|---|---|
| Receipt number | R000071887 |
| Scientific Title | A Study to Evaluate the Equivalence Between the Self-Administered Digital Cognitive Assessment Tool MoCA Solo-J and Its Paper-Based Version, MoCA-J |
| Date of disclosure of the study information | 2026/10/06 |
| Last modified on | 2026/10/06 11:15:09 |
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Basic information
Public title
A Study to Evaluate the Equivalence Between the Self-Administered Digital Cognitive Assessment Tool MoCA Solo-J and Its Paper-Based Version, MoCA-J
Acronym
An Equivalence Study of MoCA Solo-J and the Paper-Based MoCA-J
Scientific Title
A Study to Evaluate the Equivalence Between the Self-Administered Digital Cognitive Assessment Tool MoCA Solo-J and Its Paper-Based Version, MoCA-J
Scientific Title:Acronym
An Equivalence Study of MoCA Solo-J and the Paper-Based MoCA-J
Region
| Japan |
Condition
Condition
To verify the equivalence between the paper-and-pencil cognitive assessment tool MoCA-J (Japanese version of the Montreal Cognitive Assessment) and MoCA Solo-J, a fully self-administered digital cognitive assessment tool (Japanese version of MoCA Solo).
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the equivalence between the paper-and-pencil cognitive assessment tool MoCA-J (Japanese version of the Montreal Cognitive Assessment) and MoCA Solo-J, a fully self-administered digital cognitive assessment tool (Japanese version of MoCA Solo).
Basic objectives2
Others
Basic objectives -Others
This study will enroll 50 patients aged 40-90 years with subjective or objective cognitive complaints who visit the Department of Neurology at Oita University Hospital. Using a prospective, randomized crossover design, each participant will undergo both the paper-and-pencil MoCA-J and MoCA Solo-J, administered approximately 4 weeks apart (+/-7 days). The study will evaluate the agreement between the total scores of the two tests (using CCC, RMSD, etc.), the correlation of domain-specific scores, systematic bias, the effect of the avatar-guided self-administration feature on participant performance, and usability (ease of use, burden, completion rate without assistance, etc.). The overall aim is to establish the clinical validity and utility of MoCA Solo-J as a screening tool for mild cognitive impairment (MCI) in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement between the total scores of the paper-and-pencil MoCA-J and MoCA Solo-J, assessed by:
Concordance Correlation Coefficient (CCC)
Root Mean Squared Difference (RMSD)
Distribution of the discrepancy score, and the proportion of participants whose scores differ by 1 point or less and 2 points or less
Equivalence criteria: Excellent = CCC 0.90 or higher with 80% or more of participants within +/-2 points; Good = CCC 0.80 or higher with 70% or more; Acceptable = CCC 0.70 or higher with 60% or more.
Key secondary outcomes
1. Correlation between the two tests for each cognitive domain score (visuospatial/executive function, attention, language and naming, abstraction, memory, orientation), using Pearson's correlation coefficient
2. Difference in mean domain scores between the two tests (paired t-test)
3. Assessment of systematic bias (Bland-Altman plot, one-sample t-test, linear regression)
4. Test administration time, date/time of administration, and interval between tests
5. Rate of completion without assistance and number of assistance events for MoCA Solo-J
6. Usability assessment via brief questionnaires for both administrators and participants (ease of use, perceived burden, perceived differences between the paper and digital versions, and intended follow-up actions/behavior change after receiving results)
7. Agreement in stratified analyses by background factors (age group, years of education, sex, cognitive function level, and technology familiarity)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients visiting the Department of Neurology, Oita University Hospital, who meet all of the following criteria:
1) Patients with subjective or objective cognitive complaints (selected at the discretion of the physician)
2) Patients aged 40 years or older and 90 years or younger at the time of consent
3) Native Japanese speakers
4) Patients who are able to understand the explanation of the study and provide written informed consent by themselves
Key exclusion criteria
Patients who meet any of the following criteria are excluded:
1) Patients newly prescribed anti-dementia drugs within the past 6 months (patients on long-term anti-dementia drug treatment with stable symptoms are eligible)
2) Patients whose anti-dementia medication was started or changed within the past 1 month
3) Patients with severe cognitive impairment
4) Patients with severe psychiatric disorders (such as schizophrenia or bipolar disorder)
5) Patients with alcohol or drug dependence
6) Patients with a history of serious head trauma
7) Patients with marked visual or hearing impairment
8) Patients with a physical disability that makes the use of a tablet device markedly difficult
9) Patients with suspected dementia with Lewy bodies (due to large fluctuations in cognitive function)
10) Patients judged to be inappropriate as study participants by the investigators for any other reason
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kimura |
Organization
Oita University Faculty of Medicine
Division name
Department of Neurology
Zip code
879-5593
Address
1-1 Idaigaoka, Hasma, Yufu, Oita, Japan
TEL
097-586-5814
noriyuki@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Murayama |
Organization
Theoria technologies Co., Ltd.
Division name
Product Development Department
Zip code
100-0011
Address
17F Hibiya Parkfront, 2-1-6 Uchisaiwai-cho, Chiyoda-ku, Tokyo , Japan
TEL
03-6777-9129
Homepage URL
s.murayama@theoriatec.com
Sponsor or person
Institute
Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Theoria technologies Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional review board of Oita University, Faculty of medicine
Address
1-1 Idaigaoka, Hasma, Yufu, Oita, Japan
Tel
097-586-5157
rinrikenkyu@oita-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study. Each participant undergoes both the paper-and-pencil MoCA-J and MoCA Solo-J, with an interval of 4 weeks (+/-7 days) between the two assessments. To offset learning effects and order effects, the order of the two assessments is determined at random by computer after informed consent is obtained: Arm A (paper MoCA-J first, then MoCA Solo-J) or Arm B (MoCA Solo-J first, then paper MoCA-J). Both assessments are cognitive screening tests used in routine clinical practice, and no medical intervention other than the assessments is allocated. Scoring is performed by a physician or psychologist through the administrator portal using de-identified data.
Management information
Registered date
| 2026 | Year | 10 | Month | 06 | Day |
Last modified on
| 2026 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071887
