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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028088
Receipt No. R000032156
Scientific Title EXPLORATORY RESEARCH FOR CONSTRUCTION AND APPLICATION OF A DATABASE OF THE NORMAL GABAA RECEPTOR BRAIN SPECT TO VISUALIZE NEURONAL LOSS IN NEURODEGENERATIVE DISEASES
Date of disclosure of the study information 2017/07/05
Last modified on 2017/07/05

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Basic information
Public title EXPLORATORY RESEARCH FOR CONSTRUCTION AND APPLICATION OF A DATABASE OF THE NORMAL GABAA RECEPTOR BRAIN SPECT TO VISUALIZE NEURONAL LOSS IN NEURODEGENERATIVE DISEASES
Acronym EXPLORATORY RESEARCH FOR CONSTRUCTION AND APPLICATION OF A DATABASE OF THE NORMAL GABAA RECEPTOR BRAIN SPECT TO VISUALIZE NEURONAL LOSS IN NEURODEGENERATIVE DISEASES
Scientific Title EXPLORATORY RESEARCH FOR CONSTRUCTION AND APPLICATION OF A DATABASE OF THE NORMAL GABAA RECEPTOR BRAIN SPECT TO VISUALIZE NEURONAL LOSS IN NEURODEGENERATIVE DISEASES
Scientific Title:Acronym EXPLORATORY RESEARCH FOR CONSTRUCTION AND APPLICATION OF A DATABASE OF THE NORMAL GABAA RECEPTOR BRAIN SPECT TO VISUALIZE NEURONAL LOSS IN NEURODEGENERATIVE DISEASES
Region
Japan

Condition
Condition neurodegenerative diseases such as amyotrophic lateral sclerosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By setting a wider range for the normal database of 123I-iomazenil SPECT (IMZ SPECT) it is possible to obtain information on the difference in distribution of GABAA receptor due to aging and the aim of this study is to evaluate the possibility that IMZ SPECT which has been used only for focal search of epilepsy up to now can be widely applied to neurodegenerative diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Projection data of IMZ SPECT
Key secondary outcomes Head MRI(T1,T2,FLAIR,sDWI,T2*,3D-T1,MRA)

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
60 years-old >
Gender Male
Key inclusion criteria [Normaldatabase creation]
1) Subject is aged between 20 to 60 years old (at the time of consent)
2) Subject is able to undergo necessary tests on designated dates after providing consent
3) Subject has no issues in the neuropsychological exam performed within 3 months of providing consent
4) Subject's MRI and MRA diagnostic imaging, performed within 3 months of providing consent, is age-appropriate and has no issues (although atrophy corresponding to age may be present, it is necessary that ischemic white matter lesion, lacunar infarction of 3 mm or more, cysts, and signal loss of major blood vessels in MRA are not present)
5) Subject himself can provide written consent to participate in this research
6) Subject's neuropsychological exam presents no issues (in MMSE more than 27 points).
7) Subject has been examined by a neurologist, and is confirmed to not have neurological abnormalities

(Assessment of lesional distribution)
1) 20 years or older at the time of consent
2) Subjects who can show their willingness to consent (including manifestation of intention by means of communication devices etc.), undergo the informed consent process in the presence of an impartial witness and subject himself provides consent to participate in the research.
Key exclusion criteria [Normaldatabase creation]
1) Subject is a pregnant, is capable of being pregnant, or is breast-feeding
2) Subject has a history of alcohol poisoning or is receiving treatment for it
3) SUbject has a history of epilepsy or is receiving treatment for it
4) Subject is receiving antidepressants, psychotropics, prolonged hypnotic sedatives (including anxiolytics)
5) Subject has a history of mental/neurological diseases that affect cognitive function
6) Subject has a serious complications (liver, kidney disorders and endocrine diseases etc.)
7) Smoker (more than 20 years having one-packet and more per day)

[Assessment of lesional distribution]
1) ubject is a pregnant, is capable of being pregnant, or is breast-feeding
2) Subject has a serious complications (liver, kidney disorders and endocrine diseases etc.)
Target sample size 13

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanobu Tobinaga
Organization Niigata National Hospital, National Hospital Organization
Division name Department of Neurology
Zip code
Address 3-52 Akasaka-cho Kashiwazaki city Niigata prefecture JAPAN
TEL 0257-22-2126
Email m.tobinaga@niigata-nh.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanobu Tobinaga
Organization Niigata National Hospital, National Hospital Organization
Division name Department of Neurology
Zip code
Address 3-52 Akasaka-cho Kashiwazaki city Niigata prefecture JAPAN
TEL 0257-22-2126
Homepage URL
Email m.tobinaga@niigata-nh.go.jp

Sponsor
Institute Department of Neurology, Niigata National Hospital, National Hospital Organization
Institute
Department

Funding Source
Organization Niigata National Hospital, National Hospital Organization
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 07 Month 05 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
2017 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The IMZ SPECT normal database (NDB) of healthy males between 20s to 50s is prepared and IMZ SPECT data of a patient with neurodegenerative disease is analyzed by 3-dimensional stereotactic surface projection (3D-SSP) based on this.

Management information
Registered date
2017 Year 07 Month 05 Day
Last modified on
2017 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032156

Research Plan
Registered date File name
2017/07/18 ★研究計画書 プロトコール登録版 6_8-4_EN.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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