UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003764 |
|---|---|
| Receipt number | 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 10:43:49 |
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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
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
khiraoka@cyric.tohoku.ac.jp
Sponsor or person
Institute
Cyclotron and Radioisotope Center (CYRIC), Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004560
