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
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
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
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
