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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012776
Receipt No. 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

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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
Email 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
Email mmatsuura@dent.showa-u.ac.jp

Sponsor
Institute Karasuyama Hospital Showa University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014856

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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