UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059071 |
|---|---|
| Receipt number | R000067554 |
| Scientific Title | Construction of a Structured Model for Rapid Detection of Mild Cognitive Impairment (MCI) Using the MMSE-J Sentence-Writing Item |
| Date of disclosure of the study information | 2025/09/13 |
| Last modified on | 2025/09/12 12:54:02 |
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Basic information
Public title
Rapid Detection of Mild Cognitive Impairment (MCI) through Writing Analysis
Acronym
MCI-Writing Study
Scientific Title
Construction of a Structured Model for Rapid Detection of Mild Cognitive Impairment (MCI) Using the MMSE-J Sentence-Writing Item
Scientific Title:Acronym
MCI-Writing Model
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment (MCI)
Classification by specialty
| Neurology | Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to develop a structured model for the rapid detection of mild cognitive impairment (MCI) by analyzing short written sentences from the MMSE-J sentence-writing item and identifying characteristic writing patterns.
Basic objectives2
Others
Basic objectives -Others
Exploratory development of a novel detection model for the early identification of mild cognitive impairment (MCI)
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnosis of mild cognitive impairment (MCI) defined as a global CDR score of 0.5, assessed at baseline (time of enrollment).
Key secondary outcomes
Total MMSE-J score (baseline)
Frequency and types of writing errors in the MMSE-J sentence-writing item (baseline)
Number of written characters and syntactic complexity in the sentence-writing task (baseline)
Writing time and initiation latency (baseline; if measurable)
Association with SPPB total score and GDS score (baseline; exploratory)
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age 60 years or older
No history of neurological disorders
Able to complete cognitive assessments (MMSE-J, CDR, writing tasks)
Key exclusion criteria
History of dementia diagnosis
Presence of aphasia
Inability to complete cognitive assessments
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | TAKAHIRO |
| Middle name | |
| Last name | KOWARI |
Organization
Kawasaki University of Medical Welfare
Division name
Faculty of Rehabilitation, Department of Speech-Language-Hearing Therapy
Zip code
701-0193
Address
288 Matsushima, Kurashiki-shi, Okayama 701-0193, Japan
TEL
0864621111
kowari@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | TAKAHIRO |
| Middle name | |
| Last name | KOWARI |
Organization
Kawasaki University of Medical Welfare
Division name
Faculty of Rehabilitation, Department of Speech-Language-Hearing Therapy
Zip code
701-0193
Address
288 Matsushima, Kurashiki-shi, Okayama 701-0193, Japan
TEL
0864621111
Homepage URL
kowari@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
TAKAHIRO KOWARI
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School Hospital Institutional Review Board
Address
Kawasaki Medical School Hospital, 577 Matsushima, Kurashiki-shi, Okayama
Tel
0864621111
kowari@mw.kawasaki-m.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
| 2025 | Year | 09 | Month | 13 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2031 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2031 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2031 | Year | 08 | Month | 31 | Day |
Other
Other related information
This study is an observational study with no specific intervention. The participants will be elderly patients recruited from the University Hospital and the Geriatric Medical Center. Cognitive assessments, including the MMSE-J sentence-writing item, will be conducted at baseline. This study is supported by Grants-in-Aid for Scientific Research (KAKENHI), Research Activity Start-up, Japan Society for the Promotion of Science (JSPS).
Management information
Registered date
| 2025 | Year | 09 | Month | 12 | Day |
Last modified on
| 2025 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067554
