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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003764
Receipt No. R000004560
Scientific Title Measurement of amyloid deposit in the brain of idiopathic normal-pressure hydrocephalus
Date of disclosure of the study information 2013/07/31
Last modified on 2015/12/16

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Basic information
Public title Measurement of amyloid deposit in the brain of idiopathic normal-pressure hydrocephalus
Acronym Measurement of amyloid deposit in the brain of idiopathic normal-pressure hydrocephalus
Scientific Title Measurement of amyloid deposit in the brain of idiopathic normal-pressure hydrocephalus
Scientific Title:Acronym Measurement of amyloid deposit in the brain of idiopathic normal-pressure hydrocephalus
Region
Japan

Condition
Condition idiopathic normal-pressure hydrocephalus
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measurement of amyloid deposit in the brain of idiopathic normal-pressure hydrocephalus
Basic objectives2 Others
Basic objectives -Others investigation of the pathomechanism
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes quantity of amyloid deposit in the regions of the brain measured by amyloid-PET
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
90 years-old >=
Gender Male and Female
Key inclusion criteria the patients with Alzheimer's disease or idiopathic normal-pressure hydrocephalus and normal elderly voluneteers
Key exclusion criteria past history of brain diseases such as stroke and brain contusion
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kotaro Hiraoka
Organization Cyclotron and Radioisotope Center (CYRIC), Tohoku University
Division name Division of Cyclotron Nuclear Medicine
Zip code
Address 6-3, Aoba, Aramaki, Aoba-ku, Sendai, 980-8578, JAPAN
TEL 0227957802
Email khiraoka@cyric.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Hiraoka
Organization Cyclotron and Radioisotope Center (CYRIC), Tohoku University
Division name Division of Cyclotron Nuclear Medicine
Zip code
Address 6-3, Aoba, Aramaki, Aoba-ku, Sendai, 980-8578, JAPAN
TEL 0227957802
Homepage URL
Email khiraoka@cyric.tohoku.ac.jp

Sponsor
Institute Cyclotron and Radioisotope Center (CYRIC), Tohoku University
Institute
Department

Funding Source
Organization Tohoku university
Organization
Division
Category of Funding Organization Other
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 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2010 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2014 Year 06 Month 17 Day
Date of closure to data entry
2014 Year 06 Month 17 Day
Date trial data considered complete
Date analysis concluded
2015 Year 01 Month 31 Day

Other
Other related information amyloid-PET imaging

Management information
Registered date
2010 Year 06 Month 16 Day
Last modified on
2015 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004560

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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