UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039486
Receipt No. R000045024
Scientific Title Relationships between cognitive function and biomarkers
Date of disclosure of the study information 2020/02/14
Last modified on 2020/02/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email nagashima_hirotaka@tc-clinic.jp

Sponsor
Institute Kao Corporation
Institute
Department

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
Email 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
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 Preinitiation
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

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 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045024

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.