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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016737
Receipt No. R000019426
Scientific Title Investigation of serum microRNA level of the patients with dementia for early diagnosis.
Date of disclosure of the study information 2015/03/09
Last modified on 2015/03/08

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Basic information
Public title Investigation of serum microRNA level of the patients with dementia for early diagnosis.
Acronym Investigation of serum microRNA level of the patients with dementia.
Scientific Title Investigation of serum microRNA level of the patients with dementia for early diagnosis.
Scientific Title:Acronym Investigation of serum microRNA level of the patients with dementia.
Region
Japan

Condition
Condition dementing illness
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess risk of developing dementia by measurement of serum microRNA level.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Demographic informations of the targets are age, gender, cognitive symptons(Mini-Mental State Examination, MMSE), neuroimaging test, disease duration and diagnosis. Rate of microRNA 1(let-7f/miR-122), Rate of microRNA 2(miR-144/miR-122).
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
60 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients of Yokohama city University Hospital.
Key exclusion criteria 1. Patients with mental illness other than dementia.
2. Patiens who are continuing the treatment of cancer, or who are not older than one year after surgery.
3. Patiens who has participated in other clinical trials and clinical research within four months.
4. Patients who doctor has determined ineligible.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Omi Katsuse
Organization Yokohama City University School of Medicine
Division name Department of Psychiatry
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL 045-787-2800
Email oxm08@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Omi Katsuse
Organization Yokohama City University School of Medicine
Division name Department of Psychiatry
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL 045-787-2800
Homepage URL
Email oxm08@yahoo.co.jp

Sponsor
Institute Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization Rohto Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kanagawa Health Service Association
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

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 09 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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Serum microRNA in dementia patients were measured to investigate the association of cognitive function, laboratory findings and patient background.

Management information
Registered date
2015 Year 03 Month 08 Day
Last modified on
2015 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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