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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007657
Receipt No. R000009029
Scientific Title Developing a normal database of regional cerebral blood flow of the healthy elderly over 75 years old
Date of disclosure of the study information 2012/04/03
Last modified on 2015/04/03

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Basic information
Public title Developing a normal database of regional cerebral blood flow of the healthy elderly over 75 years old
Acronym Developing a normal database of rCBF of the healthy elderly over 75 years old
Scientific Title Developing a normal database of regional cerebral blood flow of the healthy elderly over 75 years old
Scientific Title:Acronym Developing a normal database of rCBF of the healthy elderly over 75 years old
Region
Japan

Condition
Condition Healthy Elderly over 75 years old
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of the normal database of rCBF of healthy elderly over 75 years old
Basic objectives2 Others
Basic objectives -Others Development of the normal database of rCBF
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes regional cerebral blood flow
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 No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Evaluation of regional cerebral blood flow using Tc-99m-ECD
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria over 75 years old
neuropsychological test battery shows no cognitive impairment
Key exclusion criteria No past history of psychiatric and neurological disorders
Brain MRI shows no evident cerebral infarction or ischemic changes equivalent to Fazekas grade III
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Asada
Organization University of Tsukuba
Division name Department of Psychiatry Division of Clinical Meidicine, Faculty of Medicine
Zip code
Address 1-1-1Tennodai Tsukuba, Ibaraki 305-8575, Japan
TEL 029-853-3182
Email seishin@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyotaka Nemoto
Organization University of Tsukuba
Division name Department of Psychiatry Division of Clinical Meidicine, Faculty of Medicine
Zip code
Address 1-1-1 Tennodai Tsukuba Ibaraki
TEL 029-853-3182
Homepage URL
Email seishin@md.tsukuba.ac.jp

Sponsor
Institute Department of Psychiatry
Division of Clinical Meidicine, Faculty of Medicine
University of Tsukuba
Institute
Department

Funding Source
Organization FUJIFILM RI Pharma Co., Ltd
Organization
Division
Category of Funding Organization Profit 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
2012 Year 04 Month 03 Day

Related information
URL releasing protocol http://www.tsukuba-psychiatry.com/?page_id=930
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
2012 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2013 Year 09 Month 30 Day
Date of closure to data entry
2013 Year 09 Month 30 Day
Date trial data considered complete
2013 Year 09 Month 30 Day
Date analysis concluded
2014 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 04 Month 03 Day
Last modified on
2015 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009029

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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