UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014745
Receipt No. R000017141
Scientific Title The basic data for studying of elderly drivers characteristics
Date of disclosure of the study information 2014/08/01
Last modified on 2017/04/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The basic data for studying of
elderly drivers characteristics
Acronym elderly drivers characteristics
Scientific Title The basic data for studying of
elderly drivers characteristics
Scientific Title:Acronym 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
1st name
Middle name
Last name Shutaro Nakaaki
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL 03-3353-1211
Email hzi05510@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Shutaro Nakaaki
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2014 Year 07 Month 07 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.