UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061359 |
|---|---|
| Receipt number | R000070193 |
| Scientific Title | Utility of Wearable Device-Derived Biometric Data for Dementia Screening: A Pilot Observational Study in Community-Dwelling Adults |
| Date of disclosure of the study information | 2026/04/23 |
| Last modified on | 2026/04/23 11:42:18 |
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Basic information
Public title
Usefulness of Biometric Data from Wearable Devices for Dementia Screening: A Pilot Study
Acronym
WEAR-Dementia Study
Scientific Title
Utility of Wearable Device-Derived Biometric Data for Dementia Screening: A Pilot Observational Study in Community-Dwelling Adults
Scientific Title:Acronym
WEAR-Dementia Study
Region
| Japan |
Condition
Condition
Dementia (for prevention and early detection)
Classification by specialty
| Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the association between wearable-derived lifestyle data and cognitive function in community-dwelling adults, and to evaluate the feasibility and validity of these measures for dementia screening.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function (MMSE-J score), wearable-derived biometric data (physical activity, sleep, and heart rate), and acceptability of wearable devices
Key secondary outcomes
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
| 50 | years-old | <= |
Age-upper limit
| 72 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Residents of Shimonoseki City
2)Aged 50-71 years
3)No diagnosis of dementia
Key exclusion criteria
1) Severe or terminal illness
2) Difficulty in study participation
3) Inability to provide informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Kajiwara |
Organization
Shimonoseki City University
Division name
Faculty of Nursing
Zip code
7518510
Address
2-1-1, Daigakucho, Shimonoseki-shi, Yamaguchi, Japan
TEL
0832520288
kajiwara-ko@shimonoseki-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Kajiwara |
Organization
Shimonoseki City University
Division name
Faculty of Nursing
Zip code
7518510
Address
2-1-1, Daigakucho, Shimonoseki-shi, Yamaguchi, Japan
TEL
0832520288
Homepage URL
kajiwara-ko@shimonoseki-cu.ac.jp
Sponsor or person
Institute
Shimonoseki City University
Institute
Department
Personal name
Kohei Kajiwara
Funding Source
Organization
Shimonoseki City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Research Involving Human Subjects, Shimonoseki City University
Address
2-1-1, Daigakucho, Shimonoseki-shi, Yamaguchi, Japan
Tel
083-252-0288
kenkyurinri@shimonoseki-cu.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 | 04 | Month | 23 | 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
| 2026 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study examines the association between wearable-derived lifestyle data (physical activity, sleep, heart rate, etc.) and cognitive function (MMSE-J) in community-dwelling adults. In addition, the feasibility, data quality, and acceptability of wearable devices are evaluated.
Management information
Registered date
| 2026 | Year | 04 | Month | 23 | Day |
Last modified on
| 2026 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070193
