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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017795
Receipt No. R000020614
Scientific Title The effects of body fluid biomarkers on neuropsychiatric disease
Date of disclosure of the study information 2015/06/03
Last modified on 2015/12/04

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Basic information
Public title The effects of body fluid biomarkers on neuropsychiatric disease
Acronym Body fluid biomarkers in neuropsychiatric disease
Scientific Title The effects of body fluid biomarkers on neuropsychiatric disease
Scientific Title:Acronym Body fluid biomarkers in neuropsychiatric disease
Region
Japan

Condition
Condition Neuropsychiatric disease (mainly dementia)
Classification by specialty
Neurology Psychiatry Neurosurgery
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to make our study including PET imaging analysis precisely by launching the assessment of body fluid biomarkers. Moreover, the secondary purpose is to find more clinically useful biomarker in cerebrospinal fluid or blood.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association of the biomarkers observed in cerebrospinal fluid/blood with their clinical data and imaging data.
Key secondary outcomes The clinical impact of the candidate biomarkers on the diagnosis of the neuropsychiatric disease.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Disease subjects: patients with neuropsychiatric disease (mainly dementia, e.g. Alzheimer's disease and Parkinson's disease with dementia).
Controls: cognitively normal subjects.
Key exclusion criteria Only the subjects in the neuroimaging study of PET/MRI/CT are included.
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Shimada
Organization National Institute of Radiological Science, Molecular Neuroimaging Center
Division name Molecular Neuroimaging Program
Zip code
Address 4-9-1, Anagawa, Inage-ku, Chiba, Japan
TEL 043-206-3251
Email shimada@nirs.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Shimada
Organization National Institute of Radiological Science, Molecular Neuroimaging Center
Division name Molecular Neuroimaging Program
Zip code
Address 4-9-1, Anagawa, Inage-ku, Chiba, Japan
TEL 043-206-3251
Homepage URL
Email shimada@nirs.go.jp

Sponsor
Institute National Institute of Radiological Science, Molecular Neuroimaging Center
Institute
Department

Funding Source
Organization National Institute of Radiological Science
Organization
Division
Category of Funding Organization
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

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

Other
Other related information Method: during the visit for the examinations including PET scan, other blood (< 30 ml) or cerebrospinal fluid (< 15 ml) will be sampled for the assessment of candidate biomarkers. The genome DNA, cerebrospinal fluid, blood plasma, serum, and others are examined at Brain Research Institute, University of Niigata, and Institute of Physical and Chemical Research, if approved. Moreover, the bio-samples are going to be stored mainly in Brain Research Institute, Niigata. All the data are going to be shared for analysis using clinical parameters, psychometric tests, and neuroimaging.

Management information
Registered date
2015 Year 06 Month 03 Day
Last modified on
2015 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020614

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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