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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012397
Receipt No. R000014502
Scientific Title Aging alteration and gender differences of metabotropic glutamate receptor type 1 (mGluR1) density in the human brain. The [C-11]ITMM PET study.
Date of disclosure of the study information 2013/11/25
Last modified on 2017/11/20

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Basic information
Public title Aging alteration and gender differences of metabotropic glutamate receptor type 1 (mGluR1) density in the human brain. The [C-11]ITMM PET study.
Acronym Assessment of mGluR1 binding with [C-11]ITMM PET: Effect of aging alteration and gender difference.
Scientific Title Aging alteration and gender differences of metabotropic glutamate receptor type 1 (mGluR1) density in the human brain. The [C-11]ITMM PET study.
Scientific Title:Acronym Assessment of mGluR1 binding with [C-11]ITMM PET: Effect of aging alteration and gender difference.
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of aging alteration and gender difference on the brain mGluR1 binding of [C-11]ITMM.
Basic objectives2 Others
Basic objectives -Others Investigation
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Distribution volume
Key secondary outcomes

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 The dosage in the vein of [C-11]ITMM for PET/CT imaging.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. The subjects who has intention to participate in this study, and signed informed consent.
2. Male and female subjects of >=20 and <80 years, old.
3. The subject who was judged by clinical investigator by means of physical examination and laboratory tests to be eligible as a participant in this study.
Key exclusion criteria 1.The subject who has dysfunction in the liver / kidney.
2.The subject who has abnormal findings in the central nervous system.
3.The subjects having cardiac failure.
4.The subject with a history of a drug or food allergy.
5.Tobacco smoker
6.Pregnant or woman who has a chance of pregnant.
7.The subject who was judged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Ishii
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Neuroimaging
Zip code
Address 35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL 03-3964-3241
Email ishii@pet.tmig.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Ishii
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Neuroimaging
Zip code
Address 35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL 03-3964-3241
Homepage URL
Email ishii@pet.tmig.or.jp

Sponsor
Institute Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
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
2013 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 Completed
Date of protocol fixation
2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 25 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
2013 Year 11 Month 25 Day
Last modified on
2017 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014502

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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