UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006146
Receipt number R000007269
Scientific Title Analysis of genome and blood components for elucidation and treatment on dementia
Date of disclosure of the study information 2011/08/11
Last modified on 2016/04/04 11:42:24

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Basic information

Public title

Analysis of genome and blood components for elucidation and treatment on dementia

Acronym

Analysis of genome and blood components for elucidation and treatment on dementia

Scientific Title

Analysis of genome and blood components for elucidation and treatment on dementia

Scientific Title:Acronym

Analysis of genome and blood components for elucidation and treatment on dementia

Region

Japan


Condition

Condition

dementia

Classification by specialty

Psychiatry Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

For dementia, we investigate that determine neurotransmitter, neurotrophin and their genome. Thereby, we clarify its mechanism and treatment protocol.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Neuropsychiatric Inventory (NPI)

Key secondary outcomes

Mini Mental State Examination (MMSE)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Uncontrolled

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Antipsychotic agents

Interventions/Control_2

Antidepressants

Interventions/Control_3

Chinese herb

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

dementia

Key exclusion criteria

severe physical illness

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masatake Kurita

Organization

Social medical corporation Koutokukai Sato Hospital

Division name

Department of education and research

Zip code


Address

Kunugiduka 948-1, Nanyo City, Yamagata

TEL

0238-40-3170

Email

kurita@koutoku.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masatake Kurita

Organization

Social medical corporation Koutokukai Sato Hospital

Division name

Department of education and research

Zip code


Address

Kunugiduka 948-1, Nanyo City, Yamagata

TEL

0238-40-3170

Homepage URL


Email

kurita@koutoku.or.jp


Sponsor or person

Institute

Social medical corporation Koutokukai Sato Hospital

Institute

Department

Personal name



Funding Source

Organization

Social medical corporation Koutokukai Sato Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

社会医療法人 公徳会 佐藤病院(山形県)


Other administrative information

Date of disclosure of the study information

2011 Year 08 Month 11 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

J Clin Psychopharmacol. 2013 Oct;33(5):600-7. doi: 10.1097/JCP.0b013e31829798d5.
Efficacy and tolerability of risperidone, yokukansan, and fluvoxamine for the treatment of behavioral and psychological symptoms of dementia: a blinded, randomized trial.
Teranishi M1, Kurita M, Nishino S, Takeyoshi K, Numata Y, Sato T, Tateno A, Okubo Y.

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

Enrolling by invitation

Date of protocol fixation

2008 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 08 Month 11 Day

Last modified on

2016 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007269


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name