UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007657 |
|---|---|
| Receipt number | 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 09:19:41 |
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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
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
seishin@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Psychiatry
Division of Clinical Meidicine, Faculty of Medicine
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009029
