UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017442
Receipt number 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 10:58:42

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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 or person

Institute

Department of Neurology
Oita University Faculty of Medicine

Institute

Department

Personal name



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

Value
https://center6.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