UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025420 |
|---|---|
| Receipt number | R000029239 |
| Scientific Title | Establishment of a (18)F-florbetaben PET normative database of Japanese nondemented subjects and its application to detection of early cortical amyloid deposition |
| Date of disclosure of the study information | 2016/12/27 |
| Last modified on | 2018/12/28 09:20:45 |
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Basic information
Public title
Establishment of a (18)F-florbetaben PET normative database of Japanese nondemented subjects and its application to detection of early cortical amyloid deposition
Acronym
Establishment of a (18)F-FBB PET normative database of Japanese nondemented subjects
Scientific Title
Establishment of a (18)F-florbetaben PET normative database of Japanese nondemented subjects and its application to detection of early cortical amyloid deposition
Scientific Title:Acronym
Establishment of a (18)F-FBB PET normative database of Japanese nondemented subjects
Region
| Japan |
Condition
Condition
Neuropsychiatric disorders with cortical amyloid deposition such as Alzheimer's disease
Classification by specialty
| Neurology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform (18)F-florbetaben (FBB) PET in Japanese nondemented adults for establishment of its normative database and statistical evaluation of early cortical amyloid deposition using the normal database
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Establishment of a (18)F-FBB PET normative database of Japanese nondemented subjects including young adults
Key secondary outcomes
Safety assessment on (18)F-FBB PET and age-related PET positivity in Japanese normal volunteers
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 | Device,equipment |
Interventions/Control_1
Medical inquiry, physical examination, neuropsychological tests and brain MRI are performed before the inclusion of volunteers into this study. The detailed inclusion criteria are as follows:
(1) Medical inquiry, physical examination and neuropsychological tests:
Volunteers are asked about recent medical conditions in addition to educational history, medication, past medical history and favorite foods. Neuropsychological tests include Mini Mental State Examination (MMSE), logical memory and Instruction manual of Japanese version of Montreal Cognitive Assessment (MoCA-J).
(2) Brain MRI:
Volunteers who are judged cognitively normal undergo brain MRI. When ischemic white matter diseases or lacunar infarctions are found beyond normal range, subjects will be excluded from this study.
(3) (18)F-FBB PET:
Cognitively normal volunteers who are considered eligible as a result of the abovementioned tests undergo (18)F-FBB PET.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Aged 20 to 89 at the time of obtaining informed consent
(2) Those who can accomplish all the medical and imaging procedures
(3) MMSE score greater than or equal to 27
(4) Brain MRI results within normal limits for the subject's age
(5) Those who can give written informed consent before participating in this study
Key exclusion criteria
(1) Women who are or may be pregnant, or breast-feeding women
(2) History of alcohol abuse
(3) History of receiving epileptic treatment
(4) Education period less than or equal to 6 years
(5) The subject is taking antidepressants or psychotropic drugs or receiving the long-time administration of sedative agents.
(6) History of neuropsychiatric disorders that are known to cause cognition
(7) The subject is critically ill and/or medically unstable (e.g. volunteers with advanced hepatic or renal dysfunction, or with severe endocrine metabolic disease)
(8) The subject whose MRI shows that ischemic white matter disease and/or lacunar infarctions are beyond normal range according to the guideline from the Japan Brain Dock Society
(9) The subject whose MRI shows space-occupying lesions, unexpected cerebrovascular disease, neurodegenerative disease or congenital abnormality in the brain
(10) History of high amount of radiation exposure
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadaki Nakahara |
Organization
Keio University School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3837
nakahara@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadaki Nakahara |
Organization
Keio University School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3837
Homepage URL
nakahara@rad.med.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Piramal Imaging S.A.
Organization
Division
Category of Funding Organization
Outside Japan
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
| 2016 | Year | 12 | Month | 27 | 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
| 2016 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 12 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 26 | Day |
Last modified on
| 2018 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029239
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