UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015607 |
|---|---|
| Receipt number | R000017821 |
| Scientific Title | Diagnosis of Alzheimer disease using 11C-PIB PET |
| Date of disclosure of the study information | 2014/11/10 |
| Last modified on | 2016/05/31 11:24:07 |
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Basic information
Public title
Diagnosis of Alzheimer disease using 11C-PIB PET
Acronym
Diagnosis of Alzheimer disease using 11C-PIB PET
Scientific Title
Diagnosis of Alzheimer disease using 11C-PIB PET
Scientific Title:Acronym
Diagnosis of Alzheimer disease using 11C-PIB PET
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of 11C-PIB PET in the differential diagnosis of Alzheimer's type dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
relationship between 11C-PIB PET avidity and change of cognitive function.
Key secondary outcomes
relationship between 11C-PIB PETpattern and change of cognitive function.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
injection of PET tracer
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Mild dementia is suspected and is not typical AD
2) include atypical young patients
3) Regardless of sex
4) informed consent is available
Key exclusion criteria
1) typical AD
2) can not keep at rest during scan
3) bad general condition
4) receiving anti-amyloid antibody therapy
5) can not sign in the IC or can not understand the IC
6) Those who is thought to be inappropriate by researcher
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Honda |
Organization
Kyushu University Hospital
Division name
Department of clinical radiology
Zip code
Address
3-1-1 Maidashi
TEL
092-642-5695
honda@radiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Baba |
Organization
Kyushu University
Division name
Clinical Radiology
Zip code
Address
3-1-1 Maidashi
TEL
092-642-5695
Homepage URL
sbaba127@radiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
kyushu university hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2014 | Year | 11 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 05 | Day |
Last modified on
| 2016 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017821
