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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030319
Receipt No. 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

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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
Email 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
Email kmakino@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034624

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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