UMIN-CTR Clinical Trial

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