UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054688 |
|---|---|
| Receipt number | R000062498 |
| Scientific Title | Investigative study using blood biomarker testing for dementia in healthy subjects |
| Date of disclosure of the study information | 2024/06/18 |
| Last modified on | 2024/06/18 09:31:00 |
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Basic information
Public title
Investigative study using blood biomarker testing for dementia in healthy subjects
Acronym
blood biomarker testing for dementia in healthy subjects
Scientific Title
Investigative study using blood biomarker testing for dementia in healthy subjects
Scientific Title:Acronym
blood biomarker testing for dementia in healthy subjects
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, blood samples and neuropsychological assessment will be performed on a group of healthy volunteers to investigate the relationship between blood biomarker measurements and background information and neuropsychological assessment.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Background information and neuropsychological assessment of the study subjects, healthy volunteers, will be evaluated in relation to blood biomarker measurements.
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults between the ages of 40 and 85 at the time consent is obtained.
Key exclusion criteria
(i) Has participated or is currently participating in an Alzheimer's disease drug trial within the past 12 months and has received a therapeutic intervention. (ii) Has any of the following: mild cognitive impairment, Alzheimer's disease, Parkinson's disease, cerebrovascular dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, or head injury with neurological dropout symptoms or abnormal brain structure (iii) History of depression, bipolar disorder, or bipolar disorder. (iii) History of depression, bipolar disorder, schizophrenia, alcohol or drug abuse or dependence.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Tagai |
Organization
Institute of Quantum Science and Medical Science, National Institute of Quantum Science and Technology
Division name
Center for Functional Brain Imaging
Zip code
263-0024
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
TEL
043-206-3251
tagai.kenji@qst.go.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Tagai |
Organization
Institute of Quantum Science and Medical Science, National Institute of Quantum Science and Technolo
Division name
Center for Functional Brain Imaging
Zip code
263-0024
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
TEL
043-206-3251
Homepage URL
tagai.kenji@qst.go.jp
Sponsor or person
Institute
National Institute of Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology Cer tified Review Board
Address
4-9-1 Anagawa Inage-ku Chiba-shi, Chiba
Tel
043-206-4706
helsinki@qst.go.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Institute will recruit healthy volunteers who are able to participate in clinical research, obtain consent, and conduct neuropsychological assessments through self-administered and face-to-face questionnaires.
Management information
Registered date
| 2024 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062498
