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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011939
Receipt No. R000013940
Scientific Title evaluation of brain water flow by [15O]-H2O PET
Date of disclosure of the study information 2013/10/01
Last modified on 2019/04/09

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Basic information
Public title evaluation of brain water flow by [15O]-H2O PET
Acronym brain water flow by [15O]-H2O PET
Scientific Title evaluation of brain water flow by [15O]-H2O PET
Scientific Title:Acronym brain water flow by [15O]-H2O PET
Region
Japan

Condition
Condition healthy adult volunteer
hydrocephalus
Alzheimer disease
MCI
Down Syndrome
Moyamoya disease
Classification by specialty
Neurology Pediatrics Neurosurgery
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 evaluation of water distribution in each disease
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes detect the changes of water distribution in each disease
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 MRI/CT/clinical examination
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 healthy volunteers between 20 and 80 years cognitive normal subjects without severe physical complication

patients with Alzheimer disease or hydrocephalus diagnosis
Key exclusion criteria exclude the patients who are recognized as inadequate patients by doctors with responsibility in this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Tsutomu
Middle name
Last name Nakada
Organization University of Niigata,
Brain Research Institute
Division name Center for Integrated Human Brain Science
Zip code 951-8585
Address Asahimachi 1-757, Chuo-ku,Niigata
TEL 025-227-0683
Email tnakada@bri.niigata-u.ac.jp

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Suzuki
Organization University of Niigata, Brain Research Institute
Division name Center for Integrated Human Brain Science
Zip code 951-8585
Address Asahimachi 1-757, Chuo-ku,Niigata
TEL 025-227-0683
Homepage URL
Email yuji-s@bri.niigata-u.ac.jp

Sponsor
Institute Center for Integrated Human Brain Science, Brain Research Institute, University of Niigata
Institute
Department

Funding Source
Organization grant from Ministry of Education, Culture, Sports, Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Niigata
Address Asahimachi 1-757, Chuo-ku,Niigata
Tel 025-227-2006
Email shomu@med.niigata-u.ac.jp

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
2013 Year 10 Month 01 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
2013 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 10 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
2013 Year 10 Month 01 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013940

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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