UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008242 |
|---|---|
| Receipt number | R000009723 |
| Scientific Title | Evaluation of binding property to tau protein, systemic pharmacokinetics and effective dose of [11C]PBB3 |
| Date of disclosure of the study information | 2012/06/30 |
| Last modified on | 2012/10/05 15:53:36 |
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Basic information
Public title
Evaluation of binding property to tau protein, systemic pharmacokinetics and effective dose of [11C]PBB3
Acronym
Proper evaluation of [11C]PBB3 as in vivo tau imaging agent
Scientific Title
Evaluation of binding property to tau protein, systemic pharmacokinetics and effective dose of [11C]PBB3
Scientific Title:Acronym
Proper evaluation of [11C]PBB3 as in vivo tau imaging agent
Region
| Japan |
Condition
Condition
Healthy volunteer and Alzheimer's disease
Classification by specialty
| Neurology | Psychiatry | Radiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the binding property to tau protein, systemic pharmacokinetics and effective dose of [11C]PBB3
Basic objectives2
Others
Basic objectives -Others
To evaluate the binding property to tau protein, systemic pharmacokinetics and effective dose of [11C]PBB3
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative measurement of binding property to tau protein, systemic pharmacokinetics and effective dose in PET
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PET/MRI/psychological
batteries/neurological examinations
Interventions/Control_2
PET/MRI/psychological
batteries/neurological examinations
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
| 50 | years-old | <= |
Age-upper limit
| 88 | years-old | >= |
Gender
Male
Key inclusion criteria
[healthy volunteer]
50y.o.<=Age<=88y.o., cognitive normal
subjects without severe physical complication
[Alzheimer's disease (AD)]
50y.o.<=Age<=88y.o., based on J-ADNI core study [Comprehensive Research on Aging and Health, The Ministry of Health Labour and Welfare, (19122701)] except CDR and MMSE, 0.5<=CDR<=2, 12<=MMSE<=26
Key exclusion criteria
1.psychiatric complications such as drug
abuse
2.other organic brain complications such as symptomatic stroke, PD-related disorders and other neurodegenrative diseases
3.severe physical complications
4.subject who has metal such as pacemaker in the body, and cannot perform MRI examination
5.subjects with tattoo
6.subject with claustrophobia who cannot perform MRI examination
7.exclude the patients who are recognized as
inadequate patients by doctors with
resposibility in this study
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | hitoshi Shimada |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
+81-(0)43-206-3025
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
+81-(0)43-206-3025
Homepage URL
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
a consignment expense for Molecular Imaging
Program on "Research Base for PET
diagnosis" from the Ministry of Education,
Culture, Sports, Science and Technology
(MEXT), Japanese Government
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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 | 06 | Month | 30 | 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
| 2012 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | 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
| 2012 | Year | 06 | Month | 25 | Day |
Last modified on
| 2012 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009723
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
