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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038858
Receipt No. R000044312
Scientific Title Relationship between intraoral and brain environment
Date of disclosure of the study information 2019/12/12
Last modified on 2019/12/12

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Basic information
Public title Relationship between intraoral and brain environment
Acronym Relationship between intraoral and brain environment
Scientific Title Relationship between intraoral and brain environment
Scientific Title:Acronym Relationship between intraoral and brain environment
Region
Japan

Condition
Condition mild cognitive impairment, Alzheimer's disease, corticobasal degeneration, progressive supranuclear palsy, frontotemporal lobar degeneration, Parkinson's disease, Lewy body dementia, Amyotrophic lateral sclerosis/parkinsonism-dementia complex patients in Kii Peninsula, myotonic dystrophy, diffuse neurofibrillary tangles with calcification, hereditary diffuse leukoencephalopathy with spheroid, Progressive ataxia and palatal tremor, traumatic brain injury, bipolar disorder, schizophrenia
Classification by specialty
Neurology Psychiatry Radiology
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the linkage between intraoral environment (the number of remaining teeth, periodontal disease and the age of the extraction) and brain environment (accumulation of amyloids and tau-protein, brain atrophy)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between intraoral environment and brain amyloidosis, tauopathy and neurodegeneration
Key secondary outcomes Correlation between intraoral environment and clinical symptoms

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

Not applicable
Gender Male and Female
Key inclusion criteria I. 20 years of age or older at the time of obtaining consent.

II. Subjects meeting the following conditions
1.Subjects with neurodegenerative disease
1) Subjects who can be accompanied by a legal guardian on the day of study participation at the NIRS.
2) Subjects meeting criteria of tauopathy.

2.Subjects with traumatic brain injury
1) Subjects who can be accompanied by a legal guardian on the day of study participation at the NIRS.
2) Subjects with ability to make informed consent.

3.Subjects with bipolar disorder
1) Subjects with ability to make informed consent.
2) Subjects meeting criteria of bipolar disorder.

4.Subjects with schizophrenia
1) Subjects with ability to make informed consent.
2) Subjects meeting criteria of schizophrenia.

5.Healthy volunteers
1) Subjects with ability to make informed consent.
Key exclusion criteria I.Subjects with severe physical complications

II.Subjects with claustrophobia

III.Pregnant, possibly pregnant or lactating women

IV.Subjects meeting the following conditions
1.Subjects with either neurodegenerative disease or traumatic brain injury
1)Subjects with neurodegenerative disease who have organic brain disorders
2)Subjects with neurodegenerative disease who have substance-related disorders
3)Subjects with traumatic brain injury who have any psychiatric diseases
4)From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 6 months prior to the start of this study
5)Subjects who are considered to be inappropriate to participate in the study

2.Subjects with either bipolar disorder or schizophrenia
1)Subjects with other psychiatric diseases
2)Subjects with organic brain disorders
3)Subjects who have been taking papaverine or xanthine
4)Subjects with metallic medical device in the body who have bipolar disorder
5)Subjects with tattoo who have bipolar disorder
6)Subjects who tends to suicide
7)Subjects who are considered to be inappropriate to participate in the study

3.Healthy volunteers
1)Subjects with organic brain disorders
2)Subjects with substance-related disorders
3)Subjects with metallic medical device in the body
4)Subjects with tattoo
5)From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 6 months prior to the start of this study
6)Subjects who are considered to be inappropriate to participate in the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Shimada
Organization National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Division name Department of Functional Brain Imaging Research
Zip code 263-8555
Address 4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL +81-43-206-3251
Email shimada.hitoshi@qst.go.jp

Public contact
Name of contact person
1st name Kazuko
Middle name
Last name Suzuki
Organization National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Scienc
Division name Clinical Research Support Section
Zip code 263-8555
Address 4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL +81-43-206-3025
Homepage URL
Email suzuki.kazuko@qst.go.jp

Sponsor
Institute National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Oral and Maxillofacial Radiology, Tokyo Dental College
Name of secondary funder(s) Japan Agency for Medical Research and Deveropment
Department of Oral and Maxillofacial Radiology, Tokyo Dental College

IRB Contact (For public release)
Organization Certified Review Borad, National Institutes for Quantum and Radiological Sciences and Technology
Address 4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
Tel +81-43-206-4706
Email helsinki@qst.go.jp

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
2019 Year 12 Month 12 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
2019 Year 11 Month 20 Day
Date of IRB
2019 Year 11 Month 19 Day
Anticipated trial start date
2019 Year 12 Month 11 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To examine the linkage between intraoral environment (the number of remaining teeth, occlusion, periodontal disease and the age of the extraction) and brain environment (accumulation of amyloids and tau-protein, brain atrophy)

Management information
Registered date
2019 Year 12 Month 12 Day
Last modified on
2019 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044312

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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