UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004619 |
|---|---|
| Receipt number | R000004360 |
| Scientific Title | Development of Molecular Imaging System for Early Detection of Dementia |
| Date of disclosure of the study information | 2010/11/25 |
| Last modified on | 2011/06/26 12:10:06 |
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Basic information
Public title
Development of Molecular Imaging System for Early Detection of Dementia
Acronym
The Ishikawa Brain Imaging Study 2
Scientific Title
Development of Molecular Imaging System for Early Detection of Dementia
Scientific Title:Acronym
The Ishikawa Brain Imaging Study 2
Region
| Japan |
Condition
Condition
Alzheimer's disease
Neurodegenerative disease
Atherosclerotic disease
Classification by specialty
| Cardiology | Neurology | Geriatrics |
| Radiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Neuroimaging such as F-18 FDG or amyloid PET is regarded as an important tool for early detection of neurodegenerative diseases such as Alzheimer's disease (AD).
Additionally, recent studies have demonstrated that AD and cardiovascular diseases share the same risk factors such as hyperlipidemia or diabetes, developing atherosclerosis.
Atherosclerosis is associated with inflammatory process that could be visualized and assessed by molecular imaging such as F-18 FDG PET. Todate, the relationship between atherosclerotic burden and changes in neuroimaging biomarkers remains to be elucidated.
Imaging small structures such as brain and atherosclerotic plaque using PET is still a challenge because of its limited spatial resolution. Thus, we still need to develop better methods to measure such imaging signals.
The aims of this study are to develop imaging techniques or devices that are capable of clinical and preclinical assessment of AD and other forms of neurodegenerative diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
F-18 FDG PET
C-11 PIB PET
MRI
Key secondary outcomes
Atherosclerotic imaging using F-18 FDG PET and MRI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
F-18 FDG PET
C-11 PIB PET
MRI
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
1. Healthy volunteers
2. Patients with dementia
Key exclusion criteria
1. Subjects having cardiac pacemaker, aneurysm clip, in whom MRI is contraindicated.
2. Pregnant women.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Matsunari |
Organization
The Medical and Pharmacological Research Center Foundation
Division name
Clinical Research Department
Zip code
Address
Wo 32, Inoyama, Hakui-city, Ishikawa, 925-0613, Japan
TEL
0767-26-3311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayoshi Hoshiba |
Organization
The Medical and Pharmacological Research Center Foundation
Division name
Administration
Zip code
Address
Wo 32, Inoyama, Hakui-city, Ishikawa, 925-0613, Japan
TEL
0767-26-3311
Homepage URL
soumu1@mprcf.or.jp
Sponsor or person
Institute
The Medical and Pharmacological Research Center Foundation
Institute
Department
Personal name
Funding Source
Organization
Ishikawa Prefectural Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Neurology and Neurobiology of Aging, Kanazawa University School of Medical Science
Department of Cardiology, Kanazawa Medical University
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
先端医学薬学研究センター（石川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
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
| 2010 | Year | 11 | Month | 25 | Day |
Last modified on
| 2011 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004360
