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 |
* 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
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
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/
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
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
