UMIN-CTR Clinical Trial

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