UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023976 |
|---|---|
| Receipt number | R000027599 |
| Scientific Title | Plasma biomarker reflecting cerebral amyloid deposition: a multicenter study for the clinical application |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2020/09/19 01:10:01 |
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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
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
nakamura@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027599
