UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Correlation between intraoral environment and brain amyloidosis, tauopathy and neurodegeneration

Key secondary outcomes

Correlation between intraoral environment and clinical symptoms

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

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

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

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

Institute

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

Institute

Department

Personal name

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

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

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

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

2019

Year

12

Month

12

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

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 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)

Registered date

2019

Year

12

Month

12

Day

Last modified on

2019

Year

12

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044312