UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054494 |
|---|---|
| Receipt number | R000062245 |
| Scientific Title | Study for relationship analysis of cognitive function (MMSE) and amino acids in blood and urine |
| Date of disclosure of the study information | 2024/05/30 |
| Last modified on | 2024/05/27 14:12:04 |
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Basic information
Public title
Study for relationship analysis of cognitive function (MMSE) and amino acids in blood and urine
Acronym
Study for relationship analysis of cognitive function (MMSE) and amino acids in blood and urine
Scientific Title
Study for relationship analysis of cognitive function (MMSE) and amino acids in blood and urine
Scientific Title:Acronym
Study for relationship analysis of cognitive function (MMSE) and amino acids in blood and urine
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of amino acids in blood and urine on dementia risk assessment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of the relationship between cognitive function and blood amino acids
Key secondary outcomes
Analysis of the relationship between cognitive function and other blood factors (polyamines, vitamins, hematology and biochemistry tests) and urinary factors (amino acids, polyamines, vitamins) and construction of statistical models.
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
| 50 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Men and women who are between 50 and 89 years of age at the time of obtaining the informed consent.
2.Persons who are not currently undergoing treatment for any serious disease
3.Persons who are living independently (e.g., those who can shop and pay bills alone and does not need assistance with daily activities)
4.Persons who are able to come to the designated facility on the scheduled visit date
5.Persons who are fully understand the purpose and content of this examination.
Key exclusion criteria
1.Person who have been diagnosed with dementia and are taking dementia treatment medication.
2.Persons who have been diagnosed with depression and are taking antidepressant medication.
3.Persons who have undergone treatment, hospitalization, or surgery for head injuries such as stroke or subarachnoid hemorrhage.
4.Persons who have liver, kidney, heart, respiratory, endocrine, metabolic, neurological, consciousness disorders, or other diseases.
5.Persons with a history of neurodegenerative diseases, cardiovascular diseases, or thyroid disorders.
6.Persons who have had a serious illness (such as cancer) within the past 5 years.
7.Persons with diabetes (as defined by the Japan Diabetes Society).
8.Persons who have contracted infectious diseases (syphilis, HIV, HCV, HBs antigen positive).
9.Persons who are taking medication that may affect cognitive function (antipsychotics, anxiolytics, antidepressants, etc.).
10.Persons who consume excessive alcohol (consuming an average of 60g or more of pure alcohol per day, equivalent to 3 bottles of beer, 3 small bottles of sake, or 300ml of 25% shochu).
11.Persons who smoke excessively (smoking 20 or more cigarettes per day).
12.Person who tested positive for the COVID-19 antigen test at the time of the visit.
13.Persons who have had fever, respiratory symptoms, or has had close contact with a confirmed case of COVID-19 within the past 2 weeks.
14.Any other individuals deemed unsuitable for participation in this study by the study's principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Misawa |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3296-8332
misawa.koichi@kao.com
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Misawa |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3296-8332
Homepage URL
misawa.koichi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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
山崎耳鼻咽喉科クリニック（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
196
Results
There was a relationship between the primary evaluation parameters
Results date posted
| 2024 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Men and women between 50 and 89 years old
Participant flow
Screening -> Examination (cognitive function test, blood sampling)
Adverse events
None
Outcome measures
Relationship between cognitive function tests and blood amino acids
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of the relationship between cognitive function and blood amino acids
Management information
Registered date
| 2024 | Year | 05 | Month | 27 | Day |
Last modified on
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062245
