UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014087 |
|---|---|
| Receipt number | R000016401 |
| Scientific Title | Detection of tau deposition in normal brain aging and neurodegenerative disorders using tau imaging with [C-11]PBB3 and PET |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2022/06/02 18:31:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Detection of tau deposition in normal brain aging and neurodegenerative disorders using tau imaging with [C-11]PBB3 and PET
Acronym
Tau imaging of normal aging and nenrodegeneration with [C-11]PBB3
Scientific Title
Detection of tau deposition in normal brain aging and neurodegenerative disorders using tau imaging with [C-11]PBB3 and PET
Scientific Title:Acronym
Tau imaging of normal aging and nenrodegeneration with [C-11]PBB3
Region
| Japan |
Condition
Condition
Healthy volunteers and patients with neurodegenerative disorders
Classification by specialty
| Neurology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Detection of tau deposition of the brain using tau PET with [C-11]PBB3
Basic objectives2
Others
Basic objectives -Others
Investigation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Standardized uptake value ratio (SUVR)
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
The dosage in the vein of , [C-11]PiB, [F-18]FDG for PET/CT imaging.
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. Cognitively normal subjects or subjects who have neurodenegerative disorders. The subjects who has intention to participate in this study, and signed informed consent.
2. Male and female subjects of >= 20 years, old.
3. The subject who was judged by clinical investigator by means of physical examination and laboratory tests to be eligible as a participant in this study.
Key exclusion criteria
1.The subject who has dysfunction in the liver / kidney.
2.The subjects having cardiac failure.
3.The subject with a history of a drug or food allergy.
4. Pregnant or woman who has a chance of pregnant.
5.The subject who was judged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Ishii |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
1730015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
+81-3-3964-3241
ishii@pet.tmig.or.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Ishii |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
1730015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
+81-3-3964-3241
Homepage URL
ishii@pet.tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Tokyo Metropolitan Institute of Gerontology
Address
35-2 Sakaecho, Itabashiku, Tokyo 1730015, Japan
Tel
0339643241
naomi_hasegawa@tmghig.jp
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
地方独立行政法人東京都健康長寿医療センター研究所（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016401
