UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057548 |
|---|---|
| Receipt number | R000065672 |
| Scientific Title | Multimodal Biomarker Discovery Research Using Brain Imaging and Body Fluids for Diagnosis and Pathophysiological Assessment of Dementia-Related Disorders |
| Date of disclosure of the study information | 2025/04/08 |
| Last modified on | 2025/04/08 09:48:14 |
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Basic information
Public title
Comprehensive Biomarker Discovery Research Using Brain Imaging and Body Fluids for Diagnosis and Pathological Evaluation of Dementia-Related Disorders
Acronym
Biomarker Discovery Research for Dementia-Related Disorders Using Brain Imaging and Body Fluids
Scientific Title
Multimodal Biomarker Discovery Research Using Brain Imaging and Body Fluids for Diagnosis and Pathophysiological Assessment of Dementia-Related Disorders
Scientific Title:Acronym
Dementia Multimodal Biomarker Investigation
Region
| Japan |
Condition
Condition
Patients with dementia-related disorders such as Alzheimer's disease and healthy controls.
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to analyze body fluid biomarkers, including blood and cerebrospinal fluid, in patients with dementia-related disorders and healthy controls to exploratively investigate the diagnostic utility of these biomarkers across various conditions.
Basic objectives2
Others
Basic objectives -Others
the study will examine the relationship between body fluid biomarkers and brain imaging findings, as well as their associations with clinical information such as neuropsychological assessments, in order to collect fundamental data for the clinical application of these biomarkers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of body fluid biomarker measurements between dementia-related disorder patients and healthy controls
Association between body fluid biomarkers and PET ligand accumulation distribution/brain structural changes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Amyloid and tau PET examinations will be conducted.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who meet the diagnostic criteria for Mild Cognitive Impairment (MCI) and dementia/neurodegenerative diseases (Alzheimer's Disease (AD), Corticobasal Syndrome (CBS), Progressive Supranuclear Palsy (PSP), Frontotemporal Lobar Degeneration (FTLD), Parkinson's Disease (PD) and Dementia with Lewy Bodies (DLB), Amyotrophic Lateral Sclerosis (ALS), Multiple System Atrophy (MSA)).
Key exclusion criteria
Those with organic brain disorders (head injuries requiring hospitalization or consciousness disorder, evident cerebral infarction/cerebral hemorrhage, etc.).
Those with substance-related disorders (such as drug dependence).
Those with complications of serious diseases, or those who have a history of such and are deemed inappropriate for this research by the physician who is a researcher.
Those with magnetic metals in their body (tattoos or permanent makeup, pacemakers, etc.).
Those with severe claustrophobia.
Those who are pregnant, may be pregnant, or are breastfeeding.
Others deemed inappropriate as research subjects by the physician who is a researcher.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Tagai |
Organization
National Institutes for Quantum Science and Technology
National Institute for Quantum Medical Science and Technology
Division name
Brain Functional Imaging Research Center
Zip code
263-0024
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba Prefecture
TEL
043-206-3251
tagai.kenji@qst.go.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Tagai |
Organization
National Institutes for Quantum Science and Technology National Institute for Quantum Medical Scienc
Division name
Brain Functional Imaging Research Center
Zip code
263-0024
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba Prefecture
TEL
043-206-3251
Homepage URL
tagai.kenji@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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 Prefecture
Tel
043-206-3251
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
| 2025 | Year | 04 | Month | 08 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 08 | Day |
Last modified on
| 2025 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065672
