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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017978
Receipt No. R000020826
Scientific Title Comprehensive and longitudinal study for neurodegenerative dementia using [11C]PBB3 positron emission tomography
Date of disclosure of the study information 2015/06/19
Last modified on 2015/06/19

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Basic information
Public title Comprehensive and longitudinal study for neurodegenerative dementia using [11C]PBB3 positron emission tomography
Acronym Comprehensive and longitudinal study for dementia using [11C]PBB3 positron emission tomography
Scientific Title Comprehensive and longitudinal study for neurodegenerative dementia using [11C]PBB3 positron emission tomography
Scientific Title:Acronym Comprehensive and longitudinal study for dementia using [11C]PBB3 positron emission tomography
Region
Japan

Condition
Condition The dementia includes mild cognitive impairment, Alzheimer's disease, frontemporal degeneration, Lewy body disease, Parkinson's disease with dementia, corticobasal degeneration, progressive supranuclear palsy. Morever, subjects with hypertension, hyperglycemia (diabetes), and hyperlipidemia, which associate with dementia, are also included.
Classification by specialty
Neurology Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to make the tau imaging study developed in our institute using positron emission tomography in neurodegenerative dementia precisely by longitudinal and comprehensive assessment.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association of the changes observed in amyloid imaging ([11C]PIB-PET) and tau imaging ([11C]PBB3-PET) with their clinical progression of the disease such as their cognitive decline.
Key secondary outcomes The contribution of risk factor such as hypertension, hyperglycemia (diabetes), and hyperlipidemia to the cerebral amyloid/tau load or the pathophysiology of the dementia.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Both the disease severity and treatment is not considered for the criteria. With respect to subjects with hypertension, hyperglycemia, and hyperlipidemia, overlapping disease is approved.
Key exclusion criteria The subject who have already took part in the previous examination in the study of dementia using [11C]PBB3 PET imaging in a year is excluded.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Shimada
Organization National Institute of Radiological Sciences, Molecular Imaging Center
Division name Molecular Neuroimaging Program
Zip code
Address 4-9-1, Anagawa, Inage-ku, Chiba, Japan
TEL 043-206-3251
Email shimada@nirs.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Shimada
Organization National Institute of Radiological Sciences, Molecular Neuroimaging Center
Division name Molecular Neuroimaging Program
Zip code
Address 4-9-1, Anagawa, Inage-ku, Chiba, Japan
TEL 043-206-3251
Homepage URL
Email shimada@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
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
2015 Year 06 Month 19 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 Open public recruiting
Date of protocol fixation
2015 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information During the visit for the examinations including PET scans, clinical interview, physical examination with measurement of blood pressure and body mass index, and several psychometric tests are performed. Moreover, blood sampling for the assessment of metabolic syndrome associated with diabetes and hyperlipidemia is also performed (if not yet done) when intravenous injection on PET scans is carried out.
Neuroimage processing in MRI, [11C]PIB-PET, [11C]PBB3-PET, and [18F]FDG-PET is conducted in Molecular Imaging Center, National Institute of Radiological Sciences. In the future, statistical comparisons between disease and control groups and discussions with clinical information including metabolic syndrome are going to be held.

Management information
Registered date
2015 Year 06 Month 19 Day
Last modified on
2015 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020826

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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