UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the possible differential diagnosis of dementia using the measurement of the uniformity of the EEG potential distribution
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Takashi Asada
Organization	University of Tsukuba
Division name	Department of Psychiatry
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	Takashi Asada
Organization	University of Tsukuba
Division name	Department of Psychiatry
Address	1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575 Japan
TEL	029-853-3182
Homepage URL
Email	tasada@md.tsukuba.ac.jp

Sponsor
Institute	Department of Psychiatry, University of Tsukuba
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 04 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://www2.convention.co.jp/jsdr34/files/jsdr34_program_ippan.pdf
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016118