UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004619
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email soumu1@mprcf.or.jp

Sponsor
Institute The Medical and Pharmacological Research Center Foundation
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004360

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.