UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060727 |
|---|---|
| Receipt number | R000069471 |
| Scientific Title | Identification of oral bacteria involved in mild cognitive impairment and research on methods for controlling them |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/21 18:01:06 |
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Basic information
Public title
Identification of oral bacteria involved in mild cognitive impairment and research on methods for controlling them
Acronym
Oral bacteria involved in mild cognitive impairment
Scientific Title
Identification of oral bacteria involved in mild cognitive impairment and research on methods for controlling them
Scientific Title:Acronym
Oral bacteria involved in mild cognitive impairment
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to identify oral bacteria associated with the promotion of Alzheimer's disease onset, one of the pathophysiological hypotheses involving brain inflammation.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Whether dementia developed during the observation period
Key secondary outcomes
Depression, anxiety, motivation, happiness, daily life intensity
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patient group: 1) Diagnosed with mild cognitive impairment according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) by the American Psychiatric Association, and 2) scored 25 or below on the Montreal Cognitive Assessment (MoCA)-J, which evaluates multiple cognitive functions, and 20 or above on the Mini Mental State Examination (MMSE)-J.
(2) Control group: Outpatients of the Department of Oral and Maxillofacial Surgery at our hospital with normal cognitive function (MoCA score 26 points or more, MMSE-J score 28 points or more).
Key exclusion criteria
1) History of head trauma, brain tumors, or neurodegenerative diseases.
2) For the patient group, outpatient primary care physicians have already prescribed anti-dementia drugs, steroids, or antibiotics that affect oral bacteria.
Target sample size
225
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Matsubara |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Division of Neuropsychiatry, Department of Neuroscience
Zip code
7550041
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
0836222255
t-matsu@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Matsubara |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Division of Neuropsychiatry, Department of Neuroscience
Zip code
7558505
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
0836222255
Homepage URL
t-matsu@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
General Incorporated Foundation Yamaguchi Institute for Comprehensive Research on Aging
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
Tel
0836-22-2428
clin_res@yamaguchi-u.ac.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
山口大学医学部附属病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patient group will undergo cognitive function testing, psychiatric assessment, and oral bacterial sampling during the observation period (at study enrolment, one year post-enrolment, and two years post-enrolment).
The control group will undergo cognitive function testing, psychiatric assessment, and oral bacterial sampling only at study enrolment.
DNA will be extracted from the sampled oral bacteria for comprehensive oral microbiota analysis.
Management information
Registered date
| 2026 | Year | 02 | Month | 21 | Day |
Last modified on
| 2026 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069471
