UMIN-CTR Clinical Trial

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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Middle name Last name Nakada
Organization	University of Niigata, Brain Research Institute
Division name	Center for Integrated Human Brain Science
Zip code
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 Middle name Last name Suzuki
Organization	University of Niigata, Brain Research Institute
Division name	Center for Integrated Human Brain Science
Zip code
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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
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	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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013940

Contact us.