UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047214 |
|---|---|
| Receipt number | R000053810 |
| Scientific Title | Establishment of Japanese-originated comprehensive biomarker system for diagnosis and stratification of patients with various types of dementias based on multicenter alliance for brain biomarkers (MABB) |
| Date of disclosure of the study information | 2022/03/22 |
| Last modified on | 2024/03/19 10:27:35 |
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Basic information
Public title
Establishment of Japanese-originated comprehensive biomarker system for diagnosis and stratification of patients with various types of dementias based on multicenter alliance for brain biomarkers (MABB)
Acronym
Research on dementia sponsored by AMED
Scientific Title
Establishment of Japanese-originated comprehensive biomarker system for diagnosis and stratification of patients with various types of dementias based on multicenter alliance for brain biomarkers (MABB)
Scientific Title:Acronym
Research on dementia sponsored by AMED
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To establish the Japanese-originated diagnostic and stratification system for an early stage, focusing on the MCI stage, of various dementias by integrating imaging and blood biomarkers and apply this system to clinical practice and trials
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Not applicable because it is an observational study
Key secondary outcomes
Not applicable
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients of 20 years and over
2) Written informed consent can be obtained from patients or proxies.
3) Patients with MCI due to the following diseases:
(1)Alzheimer's disease
(2)corticobasal degeneration
(3)progressive supranuclear palsy
(4)frontotemporal lobar degeneration
(5)Parkinson's disease
(6)dmentia with Lewy bodies
(7)Kii-ALS-parkinsonism-dementia complex
(8)myotonic dystrophy
(9)diffuse neurofibrillary tangles with calcification
(10)idiopathic normal pressure hydrocephalus
(11)amyotrophic lateral sclerosis (ALS)
(12)multiple system atrophy
etc.
Key exclusion criteria
1) Patients who have organic brain diseases
2) Patients who have drug dependence
3) Patients who have a serious illness
4) Patients who have claustrophobia
5) Patients during the period of pregnancy and lactation
6) Patients who the researchers consider unsuitable for the research participants
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | |
| Last name | Tokuda |
Organization
National Institutes for Quantum and Radiological Science and Technology (QST)
Division name
Department of Functional Brain Imaging Research
Zip code
263-0024
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3249
ttokuda022160@gmail.com
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Tokuda |
Organization
National Institutes for Quantum and Radiological Science and Technology (QST)
Division name
Department of Functional Brain Imaging Research
Zip code
263-0024
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3249
Homepage URL
ttokuda022160@gmail.com
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board, National Institutes for Quantum and Radiological Science and Technology (QST)
Address
4-9-1 Anagawa, Inage-ku, Chiba
Tel
043-382-8001 (Ext.6838)
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
量子科学技術研究開発機構(千葉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 22 | 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
| 2022 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective, longitudinal observational study
Management information
Registered date
| 2022 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053810
