UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039486 |
|---|---|
| Receipt number | R000045024 |
| Scientific Title | Relationships between cognitive function and biomarkers |
| Date of disclosure of the study information | 2020/02/14 |
| Last modified on | 2020/12/08 10:06:38 |
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Basic information
Public title
Relationships between cognitive function and biomarkers
Acronym
Relationships between cognitive function and biomarkers
Scientific Title
Relationships between cognitive function and biomarkers
Scientific Title:Acronym
Relationships between cognitive function and biomarkers
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationships between cognitive function and biomarkers.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to examine the relationships between cognitive function and biomarkers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlations between cognitive function and blood parameters.
Key secondary outcomes
Correlations between cognitive function and biomarkers.
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
| 65 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Age>=65 and <75years
(2)Subjects who doesn't have a history of a severe diseases (cancer, infarction or stroke) within five years.
(3)Subjects who doesn't take a medication that treats the symptoms of dementia.
(4)Subjects who have given written informed consent.
Key exclusion criteria
(1)Dementia.
(2)Subjects who have a history of a stroke, subarachnoid hemorrhage and other encephalopathies.
(3)Subjects who take an antipsychotic drug, anti-anxiety drug, anti-depressant drug etc.
(4)Subjects who usually take functional foods or supplements that affects results.
(5)Heavy drinker
(6)Subjects who have been to get sick by collecting venous blood
(7)Subjects who are planned to participate in other clinical study.
(8)Subjects who cannot give written informed consent.
(9)Subjects who are judged to be inappropriate for the study by the medical doctor or investigator for other reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Nagashima |
Organization
Tokyo-center-clinic
Division name
Director of the clinical research center
Zip code
103-0028
Address
1-1-8, Yaesu, Chuo-ku, Tokyo, 103-0028, Japan
TEL
03-3276-6935
nagashima_hirotaka@tc-clinic.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Nagashima |
Organization
Tokyo-center-clinic
Division name
Clinical research center
Zip code
103-0028
Address
1-1-8, Yaesu, Chuo-ku, Tokyo, 103-0028, Japan
TEL
03-3276-6935
Homepage URL
nagashima_hirotaka@tc-clinic.jp
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
03-5630-9220
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
東京センタークリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 14 | 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
40
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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 12 | Month | 07 | Day |
Other
Other related information
To examine the relationships between cognitive function and biomarkers.
Management information
Registered date
| 2020 | Year | 02 | Month | 14 | Day |
Last modified on
| 2020 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045024
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
