UMIN-CTR Clinical Trial

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

neurodegenerative diseases such as amyotrophic lateral sclerosis

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Projection data of IMZ SPECT

Key secondary outcomes

Head MRI(T1,T2,FLAIR,sDWI,T2*,3D-T1,MRA)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Neurology, Niigata National Hospital, National Hospital Organization

Institute

Department

Personal name

Organization

Niigata National Hospital, National Hospital Organization

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2017

Year

07

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2017

Year

07

Month

05

Day

Last modified on

2017

Year

07

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032156