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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025420
Receipt No. 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

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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
Email 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
Email nakahara@rad.med.keio.ac.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029239

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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