UMIN-CTR Clinical Trial

Basic information
Public title	Excavation of onset risk of Alzheimer's disease
Acronym	Excavation of onset risk of Alzheimer's disease
Scientific Title	Excavation of onset risk of Alzheimer's disease
Scientific Title:Acronym	Excavation of onset risk of Alzheimer's disease
Region	Japan

Condition
Condition	Mild cognitive impairment (MCI) Healthy adult volunteers
Classification by specialty	Medicine in general Neurology Geriatrics Psychiatry Radiology Neurosurgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify non-genetic risk factors of conversion from MCI to Alzheimer's disease (AD) from a prospective study
Basic objectives2	Others
Basic objectives -Others	biomerker
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification of non-genetic risk factors for onset of AD via analysis of differences between MCI individuals that convert to AD and MCI nonconverters (who have been scanned using PET)
Key secondary outcomes	Group differences for each imaging and biomarker measurement.

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	40 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	<Inclusion criteria of MCI> (1)Subject who lives in Usuki city. (2)Willing and able to complete the protocol. (3)MCI who fulfilled the diagnostic criteria of Petersen (CDR 0.5). <Inclusion criteria of healthy adult volunteers> (1)Subject who lives in Usuki city. (2)Willing and able to complete the protocol. (3)Healthy adult volunteers who did not fulfill the diagnostic criteria of Petersen (CDR 0).
Key exclusion criteria	Any significant neurologic or psychiatric disease other than MCI (1). History of significant head trauma, alcohol or substance abuse (2,6,7). Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol : diabetes mellitus, thyroid disease, anemia, cardiac disease, or hypertension (3,4,5,10,11). Clinically significant and severe abnormalities in hepatic and/or renal function (8,9). Subjects who participate in another study within 3 months (12). Subjects who donated blood (over 200ml or over 400ml, within 1 month or 3 months, respectively (13). Subjects who are judged to be inadequate for their eligibility by investigators (14).
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Etsuro Middle name Last name Matsubara
Organization	Oita University Faculty of Medicine
Division name	Department of Neurology
Zip code	879-5593
Address	1-1 Idaigaoka, Hasma, Yufu, Oita 879-5593, Japan
TEL	097-586-5810
Email	etsuro@oita-u.ac.jp

Public contact
Name of contact person	1st name Noriyuki Middle name Last name Kimura
Organization	Oita University Faculty of Medicine
Division name	Department of Neurology
Zip code	879-5593
Address	1-1 Idaigaoka, Hasma, Yufu, Oita 879-5593, Japan
TEL	097-586-5814
Homepage URL	http://www.med.oita-u.ac.jp/CAMD/iryoukankei/kenkyu/index.html
Email	noriyuki@oita-u.ac.jp

Sponsor
Institute	Department of Neurology Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization	Oita prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	TOSHIBA TDK
Name of secondary funder(s)	AMED

IRB Contact (For public release)
Organization	General clinical center, Oita University hospital
Address	1-1 Idaigaoka, Hasma, Yufu, Oita 879-5593, Japan
Tel	097-586-6163
Email	gcrcjimu@oita-u.ac.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	大分大学医学部附属病院（大分県）、大分大学医学部神経内科学講座（大分県）、大分大学医学部附属病院総合臨床研究センタークリニカルトライアルユニット（大分県）、大分大学医学部先端分子イメージングセンター（大分県）、株式会社東芝ヘルスケア社ウエルネス推進部（東京都）からTDK株式会社（千葉県）に変更

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1091
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	Completed
Date of protocol fixation	2015 Year 09 Month 28 Day
Date of IRB	2015 Year 04 Month 15 Day
Anticipated trial start date	2015 Year 10 Month 26 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information	This study is a prospective observational study with three-year follow-up of mild cognitive impairment (MCI) to identify non-genetic risk factors of conversion from MCI to Alzheimer's disease via amyloid imaging.

Management information
Registered date	2015 Year 05 Month 07 Day
Last modified on	2020 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020181