UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041147 |
|---|---|
| Receipt number | R000046983 |
| Scientific Title | Relationship of amyloid beta, tau, and alpha synuclein in CSF and the clinical manifestations and severity in patients with dementia. |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2020/07/18 12:01:07 |
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Basic information
Public title
Relationship of amyloid beta, tau, and alpha synuclein in CSF and the clinical manifestations and severity in patients with dementia.
Acronym
Relationship of amyloid beta, tau, and alpha synuclein in CSF and the clinical manifestations and severity in patients with dementia.
Scientific Title
Relationship of amyloid beta, tau, and alpha synuclein in CSF and the clinical manifestations and severity in patients with dementia.
Scientific Title:Acronym
Relationship of amyloid beta, tau, and alpha synuclein in CSF and the clinical manifestations and severity in patients with dementia.
Region
| Japan |
Condition
Condition
Alzheimer's diease, Dementia with lewy bodies
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The number of patients with dementia is increasing sharply toward the super-aging society. Among them, there are various methods such as brain MRI examination and SPECT examination for early diagnosis of Alzheimer's dementia. But the highest sensitivity and specificity are the highest in amyloid beta protein 1-42 in the cerebrospinal fluid, tau protein, and phosphorylated tau protein. In addition, recent studies have shown that blood and cerebrospinal fluid have increased amyloid beta protein oligomers. In recent years, in Dementia with Lewy bodies, alpha-synuclein level has been decreased, and it has been reported to be correlated with severity. Therefore, it can be said that these amyloid beta protein, tau protein, and alpha-synuclein have established biomarker status, but except for phosphorylated tau in cerebrospinal fluid, these tests are not covered by insurance. In recent years, development of anti-dementia drugs has progressed, and the importance of early diagnosis and early treatment has been emphasized. Detailed neurological examination, a cognitive function test by a clinical psychologist, a brain MRI scan, and a SPECT are performed, and then cerebrospinal fluid/blood amyloid beta protein, tau protein, and alpha synuclein are examined, and a clinical diagnosis is made. Thus, this study is considered to be extremely interesting in considering the pathogenic mechanism of dementia including Alzheimer's dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarify the relationship between the levels of amyloid beta protein, tau protein, and alpha-synuclein in cerebrospinal fluid/blood, clinical disease type, and imaging findings.
Key secondary outcomes
To investigate the correlation between the severity of Alzheimer's disease and dementia with Lewy bodies and the levels of cerebrospinal fluid/blood amyloid beta protein, tau protein, and alpha-synuclein.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with cognitive decline who can undergo cognitive function tests and imaging tests
Key exclusion criteria
Patients on strong antithrombotic therapy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tadanori |
| Middle name | |
| Last name | Hamano |
Organization
University of Fukui, Faculty of Medical Scieneces,
Division name
Second Department of Internal Medicine
Zip code
910-1193
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui
TEL
0776-61-3111
hamano@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Tadanori |
| Middle name | |
| Last name | Hamano |
Organization
University of Fukui
Division name
Second Department of Internal Medicine
Zip code
910-1193
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui
TEL
0776-61-3111
Homepage URL
hamano@u-fukui.ac.jp
Sponsor or person
Institute
Second Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Medical Sciences, University of Fukui
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Fukui
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
Tel
0776-61-3111
hamano@u-fukui.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
| 2020 | Year | 07 | Month | 20 | 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
10
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 30 | Day |
Other
Other related information
To compare MRI image findings, cerebrospinal fluid/blood biomarker findings.
Management information
Registered date
| 2020 | Year | 07 | Month | 18 | Day |
Last modified on
| 2020 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046983
