UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014745
Receipt number 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 13:51:18

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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 or person

Institute

Department of Neuropsychiatry, Keio University School of Medicine,

Institute

Department

Personal name



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

Value
https://center6.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