UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005642 |
|---|---|
| Receipt number | R000006664 |
| Scientific Title | PIB PET study for dementia pathophysiology and diagnosis |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2018/11/29 09:11:29 |
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Basic information
Public title
PIB PET study for dementia pathophysiology and diagnosis
Acronym
PIB PET study for dementia
Scientific Title
PIB PET study for dementia pathophysiology and diagnosis
Scientific Title:Acronym
PIB PET study for dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate amyloid deposits, glucose metabolism and atrophy in dementia brain using PET and MRI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain amyloid deposition
Cerebral glucose metabolism
Brain atrophy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
PiB PET
Interventions/Control_2
FDG PET
Interventions/Control_3
MRI
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with dementia diagnosed by DSM-IV
Alzheimer disease: NINCDS-ADRDA criteria
Dementia with Lewy bodies: DLB consortium 2005 criteria
Key exclusion criteria
Severe dementia who cannot perform examinations
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamichi Murakami |
Organization
Kinki University Faculty of Medicine
Division name
Department of Radiology
Zip code
Address
377-2 Ohnohigashi, Osakasayama, Osaka
TEL
072-366-0221
murakami@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunari Ishii |
Organization
Kinki University Faculty of Medicine
Division name
Department of Radiology
Zip code
Address
377-2 Ohnohigashi, Osakasayama, Osaka
TEL
072-366-0221
Homepage URL
ishii@med.kindai.ac.jp
Sponsor or person
Institute
Kinki University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kinki University
Organization
Division
Category of Funding Organization
Self funding
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
近畿大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | 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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 25 | Day |
Last modified on
| 2018 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006664
