UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016737 |
|---|---|
| Receipt number | 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 17:40:53 |
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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
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
oxm08@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019426
