UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030319 |
|---|---|
| Receipt number | R000034624 |
| Scientific Title | Validation of assessments for preclinical AD registration |
| Date of disclosure of the study information | 2017/12/08 |
| Last modified on | 2020/09/29 21:24:29 |
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Basic information
Public title
Validation of assessments for preclinical AD registration
Acronym
Validation of assessments for preclinical AD registration
Scientific Title
Validation of assessments for preclinical AD registration
Scientific Title:Acronym
Validation of assessments for preclinical AD registration
Region
| Japan |
Condition
Condition
preclinical AD
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To easily detect preclinical AD, we examine predictability of amyloid accumulation using cognitive function test, blood test, and questionnaire.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amyloid accumulation using Positron Emission Tomography (PET)
Key secondary outcomes
Brain image: Magnetic Resonance Imaging (MRI)
Cognitive function: Mini-Mental State Examination (MMSE), clinical dementia rating (CDR), National Center for Geriatrics and Gerontology-Functional Assessment Tool (NCGG-FAT): memory, attention, executive function, processing speed, working memory
Blood sample: Single Nucleotide Polymorphism (SNP), DNA methylation, microRNA (miRNA), blood trace element
Living situation: Medical condition, medication use, educational years, lifestyle, Activities of Daily Living (ADL), amount of conversation, quality of life (QOL), Geriatric Depression Scale (GDS)
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese native speakers
2) Living in community (not institutionalized)
3) Informed written consent
4) 60-90 years old
Key exclusion criteria
1) dementia, Parkinson's disease, multiple cerebral infarction, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsia, subdural hematoma, multiple sclerosis, and head injury with after effect
2) detected infection or cerebral infarction by MRI
3) metallic substance in the body
4) major depression, bipolar disorder, alcohol or drug dependence, vitamin B12 deficiency, syphilis, and dysthyroidism
5) using psychoactive drug
6) having difficulty maintaining supine position
7) care-needs certification in the long-term care insurance system
8) HbA1c 6.5% or more
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimada |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
474-8511
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture
TEL
0562-45-5639
shimada@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Makino |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
474-8511
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture
TEL
0562-45-5639
Homepage URL
kmakino@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
AMED (Japan Agency for Medical Research and Development)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology; Research and Medical Division
Address
7-430 Morioka-cho Obu Aichi Japan
Tel
0562-46-2311
yaday@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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To easily detect preclinical AD, we examine predictability of amyloid accumulation using cognitive function test, blood test, and questionnaire.
Management information
Registered date
| 2017 | Year | 12 | Month | 08 | Day |
Last modified on
| 2020 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034624
| 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 |
