UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017442
Receipt No. R000020181
Scientific Title Excavation of onset risk of Alzheimer's disease
Date of disclosure of the study information 2015/06/01
Last modified on 2020/05/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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/ctr_e/ctr_view.cgi?recptno=R000020181

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.