UMIN-CTR Clinical Trial

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
Email	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
Email	hamano@u-fukui.ac.jp

Sponsor
Institute	Second Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046983