UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of driving ability using an actual vehicle in older adults.
Acronym	Evaluation of driving ability in older adults
Scientific Title	Evaluation of driving ability using an actual vehicle in older adults.
Scientific Title:Acronym	Evaluation of driving ability in older adults
Region	Japan

Condition
Condition	Mild cognitive impairment
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to investigate the neurobiological substrates associated with the driving ability of mild cognitive impairment using driving test and neuroimaging techniques.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The association between driving ability and neuroimaging findings.
Key secondary outcomes	Driving ability 1. Evaluation of driving skills in the same scoring method as driving test using an actual vehicle Neuroimaging techniques include 1. Functional MRI 2. Structural MRI 3. DTI (diffusion tensor imaging) 4. NIRS (near-infrared spectroscopy)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Comparing the driving skill test using an actual vehicle between participants with mild cognitive impairment and healthy elderly controls.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Participants diagnosed with mild cognitive impairment at Keio University Hospital 2. Healthy controls scored more than 24 points in MMSE 3. Reliable informed consent could be obtained from the patient and or his her relatives
Key exclusion criteria	1. Participants were required to have had no lifetime history of any psychiatric disorders, or drug or alcohol misuse, as well as no neurological disorder 2. none of the participants reported unstable medical condition and history of significant head trauma.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Masaru Middle name Last name Mimura
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi Shinjuku-Ku, Tokyo
TEL	03-3353-1211
Email	mimura@a7.keio.jp

Public contact
Name of contact person	1st name Bun Middle name Last name Yamagata
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi Shinjuku-Ku, Tokyo
TEL	03-5363-3971
Homepage URL
Email	yamagata@a6.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University
Address	35 Shinanomachi Shinjuku-Ku, Tokyo
Tel	03-5363-3503
Email	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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 01 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	2016 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 01 Day
Last modified on	2020 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023904