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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004195 |
Receipt No. | R000005042 |
Scientific Title | PET Imaging of Brain Amyloid Using 11C-PIB in Neurological Diseases |
Date of disclosure of the study information | 2010/09/13 |
Last modified on | 2016/03/14 |
Basic information | ||
Public title | PET Imaging of Brain Amyloid Using 11C-PIB in Neurological Diseases | |
Acronym | 11C-PIB PET in Neurological Diseases | |
Scientific Title | PET Imaging of Brain Amyloid Using 11C-PIB in Neurological Diseases | |
Scientific Title:Acronym | 11C-PIB PET in Neurological Diseases | |
Region |
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Condition | |||
Condition | Alzheimer's disease
Neurodegenerative diseases |
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Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Recent advances in the development of PET tracers such as 11C-PIB can assess noninvasive brain amyloid deposits, which are the specific biomarker for Alzheimer's disease and can be an important method for early diagnosis or differential diagnosis in Alzheimer's disease or other neurolodegenerative diseases. The purpose of this study is to evaluate 11C-PIB PET imaging for diagnosis of Alzheimer's disease. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 11C-PIB PET imaging |
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 | Diagnosis | ||
Type of intervention |
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Interventions/Control_1 | 11C-PIB
PET |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Patients with cognitive dysfunction and suspicion of Alzheimer's disease | |||
Key exclusion criteria | 1. Patients who cannot stay rest on a scanner bed at least for 20 minutes | |||
Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyoto University Graduate School of Medicine | ||||||
Division name | Human Brain Research Center | ||||||
Zip code | |||||||
Address | Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan | ||||||
TEL | 075-751-3695 | ||||||
fukuyama@kuhp.kyoto-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kyoto University Graduate School of Medicine | ||||||
Division name | Human Brain Research Center | ||||||
Zip code | |||||||
Address | Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan | ||||||
TEL | 075-751-3695 | ||||||
Homepage URL | |||||||
noishi@kuhp.kyoto-u.ac.jp |
Sponsor | |
Institute | Human Brain Research Center, Kyoto University Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | J-ADNI |
Organization | |
Division | |
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Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005042 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |