UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012629 |
|---|---|
| Receipt number | R000014766 |
| Scientific Title | Development of plasma biomarkers for Alzheimer's disease |
| Date of disclosure of the study information | 2013/12/19 |
| Last modified on | 2014/11/28 16:22:46 |
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Basic information
Public title
Development of plasma biomarkers for Alzheimer's disease
Acronym
Plasma biomarkers for AD
Scientific Title
Development of plasma biomarkers for Alzheimer's disease
Scientific Title:Acronym
Plasma biomarkers for AD
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Development of plasma biomarkers for the diagnosis of Alzheimer's disease and the early detection of preclinical Alzheimer's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity for the diagnosis of Alzheimer's disease and the early detection of preclinical Alzheimer's disease
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Alzheimer's disease diagnosed on the criteria proposed by NIH/AA (2011), showing positive amyloid imaging
2. Mild cognitive impairment (MCI) likely due to Alzheimer's disease, showing positive amyloid imaging
3. Cognitively normal state without organic brain lesions
Corresponding to any of the above-mentioned criteria
Key exclusion criteria
Neuropsycological disorders other than Alzheimer's disease being suspected to causes of the cognitive decline
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Yanagisawa |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Development of Advanced Medicine for Dementia
Zip code
Address
7-430, Morioka, Obu, Aichi, Japan
TEL
0562-46-2311
katuhiko@ncgg.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Yanagisawa |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Development of Advanced Medicine for Dementia
Zip code
Address
7-430, Morioka, Obu, Aichi, Japan
TEL
0562-44-6594
Homepage URL
katuhiko@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Koichi Tanaka Laboratory of Advanced Science and Technology, Shimadzu Corporation
Name of secondary funder(s)
Shimadzu Corporation
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/pjab/90/9/90_PJA9009B-04/_article
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
Main results already published
Date of protocol fixation
| 2013 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 30 | Day |
Other
Other related information
Analyses of novel amyloid-related proteins in plasma will be performed using mass spectrometry in addition to neuropsycological examination, determination of the genotype of apolipoprotein E, measurement of cerebrospinal fluid biomarkers and neuroimaging using MRI and PET (amyloid imaging).
Management information
Registered date
| 2013 | Year | 12 | Month | 19 | Day |
Last modified on
| 2014 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014766
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
