UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038858 |
|---|---|
| Receipt number | 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 01:22:36 |
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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
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
suzuki.kazuko@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044312
