UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012776 |
|---|---|
| Receipt number | R000014856 |
| Scientific Title | Relationship between cognitive function and oral health condition, swallowing function, or serum brai derived neurotrophic factor (BNDF) contents in dementia. |
| Date of disclosure of the study information | 2014/01/07 |
| Last modified on | 2014/01/07 14:52:55 |
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Basic information
Public title
Relationship between cognitive function and oral health condition, swallowing function, or serum brai derived neurotrophic factor (BNDF) contents in dementia.
Acronym
Congitive function and oral function
Scientific Title
Relationship between cognitive function and oral health condition, swallowing function, or serum brai derived neurotrophic factor (BNDF) contents in dementia.
Scientific Title:Acronym
Congitive function and oral function
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Psychiatry | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigation relationships between checking oral health or swallowing function or demented patients and their cognitive function or their serum BDNF contents, contribute to prevention of their aspiration pneumonia and their malnutrition.
Basic objectives2
Others
Basic objectives -Others
To prevent their aspiration pneumonia and their malnutrition.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral health, swallowing function
Key secondary outcomes
Cognitive function, serum BDNF contents
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Examination
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed as dementia and hospitalized to Showa university Karasuyama hospital.
Key exclusion criteria
Severe demented patients who are difficult to observe their oral health and swallowing function.
Patients who are identified as not suitable to the study by psychiatrists or dentists.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Matsuura |
Organization
Karasuyama Hospital Showa University
Division name
Department of Dentistry
Zip code
Address
6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo 157-8577, Japan
TEL
03-3300-5231
mmatsuura@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Matsuura |
Organization
Karasuyama Hospital Showa University
Division name
Department of Dentistry
Zip code
Address
6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo 157-8577, Japan
TEL
03-3300-5231
Homepage URL
mmatsuura@dent.showa-u.ac.jp
Sponsor or person
Institute
Karasuyama Hospital Showa University
Institute
Department
Personal name
Funding Source
Organization
Karasuyama Hospital Showa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 01 | Month | 07 | 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
| 2013 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 07 | Day |
Last modified on
| 2014 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014856
