UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049044
Receipt number R000055873
Scientific Title Dementia Biomarker Study of Human Health Screening Patients
Date of disclosure of the study information 2022/09/29
Last modified on 2022/09/28 10:16:31

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Basic information

Public title

Dementia Biomarker Study of Human Health Screening Patients

Acronym

Biomarker Study of Human Health Screening

Scientific Title

Dementia Biomarker Study of Human Health Screening Patients

Scientific Title:Acronym

Biomarker Study of Human Health Screening

Region

Japan


Condition

Condition

dementia

Classification by specialty

Neurology Geriatrics Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, blood biomarkers for dementia will be measured in patients undergoing physical checkups, with the aim of establishing a biomarker evaluation method and early diagnosis of high-risk groups for dementia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Positive rates of plasma phosphorylated tau, plasma amyloid beta 42/40, and Neurofilament L

Key secondary outcomes

Changes over time with neuropsychological testing


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects who agreed to participate in the dementia biomarker study at the time of their physical examination at the Center for Preventive Medicine.

Key exclusion criteria

Those who did not agree to participate in the Dementia Biomarker Study. Those who are incapable of making decisions due to dementia, etc., and are under 18 years of age.

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name DAISUKE
Middle name
Last name Ito

Organization

Keio University School of Medicine

Division name

Department of Physiology/Memory center

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan

TEL

03-5363-3747

Email

dito@keio.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Ito

Organization

Keio University School of Medicine

Division name

Department of Physiology/Memory center

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan

TEL

03-5363-3747

Homepage URL

https://keio-memory-clinic.com/

Email

d-ito@jk9.so-net.ne.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Keio University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine Ethics Committee

Address

35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan

Tel

0333531211

Email

med-rinri-jimu@adst.keio.ac.jp


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

慶應義塾大学病院


Other administrative information

Date of disclosure of the study information

2022 Year 09 Month 29 Day


Related information

URL releasing protocol

https://keio-memory-clinic.com/

Publication of results

Unpublished


Result

URL related to results and publications

https://keio-memory-clinic.com/

Number of participants that the trial has enrolled

2000

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

2022 Year 09 Month 28 Day

Date of IRB

2022 Year 09 Month 27 Day

Anticipated trial start date

2022 Year 11 Month 01 Day

Last follow-up date

2032 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

n/a


Management information

Registered date

2022 Year 09 Month 28 Day

Last modified on

2022 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055873


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name