UMIN-CTR Clinical Trial

Public title

The Ishikawa Brain Imaging Study

Acronym

IBIS

Scientific Title

The Ishikawa Brain Imaging Study

Scientific Title:Acronym

IBIS

Region

Japan

Condition

Alzheimer's disease
Neurodegenerative disease
Atherosclerotic disease

Classification by specialty

Cardiology	Neurology	Geriatrics
Radiology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

Neuroimaging such as F-18 FDG PET 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.
The aims of this study are to establish Japanese standard brain images, and to seek imaging biomarkers for clinical and preclinical assessment of AD and other forms of neurodegenerative diseases using PET and MRI.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

F-18 FDG PET
C-11 PIB PET (Optional)
MRI

Key secondary outcomes

Atherosclerotic imaging using F-18 FDG PET and MRI (Optional)

Study type

Interventional

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

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 (Optional)
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

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

1200

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

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

Institute

The Medical and Pharmacological Research Center Foundation

Institute

Department

Personal name

Organization

Ishikawa Prefectural Government

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

先端医学薬学研究センター（石川県）

Date of disclosure of the study information

2010

Year

05

Month

12

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

1. Chen WP, Samuraki M, Yanase D, Shima K, Takeda N, Ono K, Yoshita M, Nishimura S, Yamada M, Matsunari I. Effect of sample size for normal database on diagnostic performance of brain FDG PET for the detection of Alzheimer's disease using automated image analysis. Nucl Med Commun. 2008;29:270-276

2. Samuraki M, Matsunari I, Chen WP, Yajima K, Yanase D, Fujikawa A, Takeda N, Nishimura S, Matsuda H, Yamada M. Partial volume effect-corrected FDG PET and grey matter volume loss in patients with mild Alzheimer's disease. Eur J Nucl Med Mol Imaging. 2007;34:1658-1669

3. Matsunari I, Samuraki M, Chen WP, Yanase D, Takeda N, Ono K, Yoshita M, Matsuda H, Yamada M, Kinuya S. Comparison of 18F-FDG PET and Optimized Voxel-Based Morphometry for Detection of Alzheimer's Disease: Aging Effect on Diagnostic Performance. J Nucl Med. 2007;48:1961-1970

4. Yanase D, Matsunari I, Yajima K, Chen W, Fujikawa A, Nishimura S, Matsuda H, Yamada M. Brain FDG PET study of normal aging in Japanese: effect of atrophy correction. Eur J Nucl Med Mol Imaging. 2005;32:794-805

5. Chen WP, Matsunari I, Noda A, Yanase D, Yajima K, Takeda N, Yamada M, Minoshima S, Nishimura S. Rapid scanning protocol for brain (18)F-FDG PET: a validation study. J Nucl Med. 2005;46:1633-1641

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

Recruitment status

Completed

Date of protocol fixation

2002

Year

01

Month

21

Day

Date of IRB

Anticipated trial start date

2002

Year

02

Month

01

Day

Last follow-up date

2010

Year

11

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

05

Month

12

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=R000004370