UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062461 |
|---|---|
| Receipt number | R000071488 |
| Scientific Title | An observational study on the association between cognitive function assessment and driving behavior data in older taxi drivers |
| Date of disclosure of the study information | 2026/08/04 |
| Last modified on | 2026/08/04 09:15:15 |
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Basic information
Public title
An observational study on the association between cognitive function assessment and driving behavior data in older taxi drivers
Acronym
Cognitive function and driving behavior in older taxi drivers
Scientific Title
An observational study on the association between cognitive function assessment and driving behavior data in older taxi drivers
Scientific Title:Acronym
Cognitive function and driving behavior in older taxi drivers
Region
| Japan |
Condition
Condition
Healthy older adults (taxi drivers aged 60 years or older)
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between cognitive function (Mini-Mental State Examination [MMSE] and other measures) and driving behavior data in older taxi drivers, and to exploratorily clarify the influence of differences in cognitive function on driving behavior indices.
Basic objectives2
Others
Basic objectives -Others
Exploratory examination of the association between cognitive function assessment and driving behavior data obtained in real-world driving environments
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive function assessed by the Mini-Mental State Examination (MMSE), the Logical Memory subtest of the Wechsler Memory Scale-Revised (WMS-R LM), the Clock Drawing Test (CDT), and the Visual Field with Inhibitory Task (VFIT)
Key secondary outcomes
Subscale scores of each cognitive assessment and their associations with age, sex, driving history, medical history, medication history, and history of traffic accidents and violations. In addition, where driving behavior data held by NTT DATA are available, associations with these data will be examined in an exploratory manner.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Taxi drivers who participated in a previous study conducted by NTT DATA and for whom driving behavior data have been obtained, who received an explanation of this study and expressed their intention to participate
2. Taxi drivers aged 60 years or older at the time of informed consent
3. Persons who provide written informed consent to participate in this study
Key exclusion criteria
1. Persons who have difficulty responding to face-to-face or self-administered assessment scales
2. Persons judged by the principal investigator or co-investigators to be inappropriate for participation in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura |
Organization
Keio University
Division name
Center for Preventive Medicine
Zip code
106-0041
Address
7F Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo 106-0041, Japan
TEL
03-5363-3685
mimura.a7@keio.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Miyasaka |
Organization
Keio University
Division name
Department of Neuropsychiatry, Keio University School of Medicine
Zip code
106-0041
Address
7F Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo 106-0041, Japan
TEL
03-5363-3685
Homepage URL
miyasaka.a5@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
NTT DATA Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
慶應義塾大学(東京都)、株式会社NTTデータ(東京都)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 04 | 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 | 05 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2026 | Year | 08 | Month | 04 | Day |
Last modified on
| 2026 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071488
