UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013810
Receipt number R000016118
Scientific Title Study on the possible differential diagnosis of dementia using the measurement of the uniformity of the EEG potential distribution
Date of disclosure of the study information 2014/04/26
Last modified on 2016/05/04 18:28:03

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Basic information

Public title

Study on the possible differential diagnosis of dementia using the measurement of the uniformity of the EEG potential distribution

Acronym

Study on the possible differential diagnosis of dementia using the measurement of the uniformity of the EEG potential distribution

Scientific Title

Study on the possible differential diagnosis of dementia using the measurement of the uniformity of the EEG potential distribution

Scientific Title:Acronym

Study on the possible differential diagnosis of dementia using the measurement of the uniformity of the EEG potential distribution

Region

Japan


Condition

Condition

Mild Cognitive Impairment (MCI)

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Validation of the effect of the interventions for the individuals with Mild Cognitive Impairment

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Neuronal activity measued using the electroencephalography (EEG) records

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

exercise

Interventions/Control_2

control

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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Mild cognitive impairment(MCI) patients

Key exclusion criteria

not applicable

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Asada

Organization

University of Tsukuba

Division name

Department of Psychiatry

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575 Japan

TEL

029-853-3182

Email

tasada@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Asada

Organization

University of Tsukuba

Division name

Department of Psychiatry

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575 Japan

TEL

029-853-3182

Homepage URL


Email

tasada@md.tsukuba.ac.jp


Sponsor or person

Institute

Department of Psychiatry, University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency, RISTEX

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Brain Functions Laboratory, Inc.
RENAISSANCE INC.

Name of secondary funder(s)



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

筑波大学附属病院(茨城県)


Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 26 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://www2.convention.co.jp/jsdr34/files/jsdr34_program_ippan.pdf

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

Main results already published

Date of protocol fixation

2014 Year 04 Month 18 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 01 Day

Last follow-up date

2015 Year 03 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 04 Month 25 Day

Last modified on

2016 Year 05 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016118


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name