UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062771 |
|---|---|
| Receipt number | R000071825 |
| Scientific Title | Study of developing an early detection and prevention tool for amyloid beta accumulation in the brain using biosensors |
| Date of disclosure of the study information | 2026/09/03 |
| Last modified on | 2026/09/01 14:33:34 |
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Basic information
Public title
Study of developing an early detection and prevention tool for amyloid beta accumulation in the brain using biosensors
Acronym
Study of developing an early detection and prevention tool for amyloid beta accumulation in the brain using biosensors
Scientific Title
Study of developing an early detection and prevention tool for amyloid beta accumulation in the brain using biosensors
Scientific Title:Acronym
Study of developing an early detection and prevention tool for amyloid beta accumulation in the brain using biosensors
Region
| Japan |
Condition
Condition
mild cognitive impairment and subjective cognitive decline
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to establish an assessment algorithm for predicting and stratifying the risk of amyloid beta accumulation in the brain without requiring PET, and an implementation model that can be integrated into municipal dementia prevention programs.
Basic objectives2
Others
Basic objectives -Others
To identify risk and protective factors associated with cerebral amyloid beta accumulation and cognitive decline.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function tests, brain imaging, lifestyle and sleep parameters measured using wearable sensors, and blood-based assessments
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Subject who lives in Beppu City, Oita Prefecture
2.Men and women who are between 50 and 89 years of age at the time of obtaining informed consent
3.To be physically and mentally healthy
4.Not diagnosed with dementia
5.Independent in activities of daily living
6.Willing and able to complete the protocol
7.Clinical Dementia Rating (CDR) score of 0 or 0.5
Key exclusion criteria
1.Any significant neurological, psychiatric, or neurodegenerative disease or substance dependence, or a history thereof, that may cause cognitive decline unrelated to Alzheimer's disease
2.3.History of significant alcohol or substance abuse
4.5.Clinically significant and severe abnormalities in hepatic and/or renal function
6.Subjects who participate in another study within 3 months
7.Subjects who donated blood (over 200ml or over 400ml, within 1 month or 3 months, respectively
8.Subjects who are judged to be inadequate for their eligibility by investigators
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kimura |
Organization
Oita University Faculty of Medicine
Division name
Department of Neurology
Zip code
879-5593
Address
1-1 Idaigaoka, Hasma, Yufu, Oita, Japan
TEL
097-586-5814
noriyuki@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kimura |
Organization
Oita University Faculty of Medicine
Division name
Department of Neurology
Zip code
879-5593
Address
1-1 Idaigaoka, Hasma, Yufu, Oita, Japan
TEL
097-586-5814
Homepage URL
noriyuki@oita-u.ac.jp
Sponsor or person
Institute
Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional review board of Oita University, Faculty of medicine
Address
1-1 Idaigaoka, Hasma, Yufu, Oita, Japan
Tel
097-586-5157
rinrikenkyu@oita-u.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 03 | 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
| 2026 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2031 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 09 | Month | 01 | Day |
Last modified on
| 2026 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071825
