UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047402 |
|---|---|
| Receipt number | R000051952 |
| Scientific Title | Research on the search for metabolites in saliva that are affected by dementia |
| Date of disclosure of the study information | 2022/04/27 |
| Last modified on | 2023/04/05 12:19:10 |
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Basic information
Public title
Exploring saliva components specifically for dementia patients
Acronym
Exploring Saliva Composition in Patients with Dementia
Scientific Title
Research on the search for metabolites in saliva that are affected by dementia
Scientific Title:Acronym
Metabolites in saliva of dementia patients
Region
| Japan |
Condition
Condition
Dementia
Mild cognitive impairment
Classification by specialty
| Neurology | Geriatrics | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore salivary metabolites specific to patients with dementia and mild cognitive impairment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
metabolome analysis
Key secondary outcomes
Japanese version of Montoreal Cognitive Assessment
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a diagnosis of dementia or mild cognitive impairment by a specified physician
Key exclusion criteria
Patients other than those with dementia or mild cognitive impairment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Kimoto |
Organization
Kanagawa dental University
Division name
Department of Fixed Prosthodontics
Zip code
238-8580
Address
82 Inaoka-cho Yokohama-shi Kanagawa, Japan
TEL
046(822)9532
k.kimoto@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Hoshi |
Organization
Kanagawa dental University
Division name
Department of Fixed Prosthodontics
Zip code
238-8580
Address
82 Inaoka-cho Yokohama-shi Kanagawa, Japan
TEL
046(822)8884
Homepage URL
hoshi@kdu.ac.jp
Sponsor or person
Institute
Kanagawa dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical University
Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa dental University
Address
82 Inaoka-cho Yokohama-shi Kanagawa, Japan
Tel
046(822)9690
murakami@kdu.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
神奈川歯科大学附属病院（神奈川県）
Kanagawa Dental University Hospital(Kanagawa,Japan)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 27 | 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 | 10 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analytical study: cross-sectional study
Method of recruiting subjects
Items to be measured: saliva at rest (spit method) and saliva during stimulation (gum method)
Patients who visited Kanagawa Dental College Hospital from May 2019 to November 2021
Management information
Registered date
| 2022 | Year | 04 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051952
