UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The basic data for studying of elderly drivers characteristics
Title of the study (Brief title)	elderly drivers characteristics
Region	Japan

Condition
Condition	Normal elderly, Mild cognitive disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the elderly drivers characteristics in normal elderly and mild cognitive disorders used by both driving simulator, View Filed with Inhibitory Tasks and multi-modal neuroimaging analysis (structural and functional neuroimaging)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	driving simulator, View Filed with Inhibitory Tasks(VFIT), questionnaire, diffusion tensor imaging (DTI), near-infrared spectroscopy (NIRS)
Key secondary outcomes	1 Cognitive assessment Mini-Mental State Examination (MMSE) Frontal assessment battery (FAB) 2 Behavior assessment Driving behavior questionnaire (DBQ)

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	The participants were performed with cognitive assessment, questionnaire, diffusion tensor imaging (DTI), near-infrared spectroscopy (NIRS)
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	95 years-old >=
Gender	Male and Female
Key inclusion criteria	normal elderly mild cognitive disorders
Key exclusion criteria	A previous history of mental disorders, the patient was taking antipsychotic drugs, the patient has pacemakers, the patients with severe physical disease
Target sample size	60

Research contact person
Name of lead principal investigator	Shutaro Nakaaki
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL	03-3353-1211
Email	hzi05510@nifty.com

Public contact
Name of contact person	Shutaro Nakaaki
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL	03-3353-1211
Homepage URL
Email	hzi05510@nifty.com

Sponsor
Institute	Department of Neuropsychiatry, Keio University School of Medicine,
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	none
Name of secondary funｄer(s)	none

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	慶應義塾大学病院（東京都）　　 Keio University School of Medicine (Tokyo)

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 07 Month 07 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 01 Day
Last modified on	2017 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017141