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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000014087 |
Receipt No. | 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 | 2020/06/03 |
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 | |
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Condition | |||
Condition | Healthy volunteers and patients with neurodegenerative disorders | ||
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 70 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology |
Institute | |
Department |
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 |
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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 | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016401 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |