UMIN-CTR Clinical Trial

Basic information
Public title	Plasma biomarker reflecting cerebral amyloid deposition: a multicenter study for the clinical application
Acronym	Plasma biomarker for Alzheimer's disease
Scientific Title	Plasma biomarker reflecting cerebral amyloid deposition: a multicenter study for the clinical application
Scientific Title:Acronym	Plasma biomarker for Alzheimer's disease
Region	Japan

Condition
Condition	Alzheimer's disease Other Dementia Mild cognitive impairment (MCI) Healthy volunteer
Classification by specialty	Neurology Geriatrics Psychiatry Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We have recently developed a novel plasma biomarker capable of highly sensitive detection of brain amyloid deposition (Kaneko et al., Proc Jpn Acad Ser B Phys Biol Sci, 2014). The objective of this study is to validate it's usefulness and plausibility for the clinical application by a multicenter study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	The primary endpoint of the study is to evaluate the ability of our plasma biomarkers to estimate the presence (or absence) of brain amyloid deposition, by referring the results of amyloid-PET imaging as the gold standard.
Key secondary outcomes	1) To test quantitative correlation between plasma biomarker values and brain amyloid deposition. 2) To evaluate the performances (e.g. sensitivity and specificity) of the biomarkers for each clinical category 3) Longitudinal changes between the changes in clinical symptoms and biomarker values.

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Alzheimer's disease (AD) 2) non-AD dementia 3) Mild cognitive impairment (MCI) 4) Healthy volunteer Having no significant disease and good state of the body condition.
Key exclusion criteria	Having a risk for the MRI measurements, such as a heart pacemaker, implanted body metals, and a nerve stimulator. Having significant disease. A history of alcohol or drug addiction.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Akinori Middle name Last name Nakamura
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Clinical and Experimental Neuroimaging
Zip code	474-8511
Address	7-430, Morioka, Obu, Aichi, Japan
TEL	0562-46-2311
Email	nakamura@ncgg.go.jp

Public contact
Name of contact person	1st name Akinori Middle name Last name Nakamura
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Clinical and Experimental Neuroimaging
Zip code	474-8511
Address	7-430, Morioka, Obu, Aichi, Japan
TEL	0562-46-2311
Homepage URL
Email	nakamura@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	The Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	The Tokyo Metropolitan Institute of Gerontology Kindai University Hospital Koichi Tanaka Mass Spectrometry Research Laboratory, Shimadzu Corporation
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Geriatrics and Gerontology
Address	7-430, Morioka-cho Obu-shi, Aichi 474-8511, Japan
Tel	0562-46-2311
Email	honda-r@ncgg.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	国立長寿医療研究センター（愛知県） 東京都健康長寿医療センター研究所（東京都） 近畿大学医学部附属病院　早期認知症センター（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 01 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	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 07 Day
Date of IRB	2016 Year 09 Month 09 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a multicenter study in Japan. The study design is mainly prospective, but it also analyze available retrospective data sets.

Management information
Registered date	2016 Year 09 Month 08 Day
Last modified on	2020 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027599