UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023623 |
|---|---|
| Receipt number | R000027206 |
| Scientific Title | Aarakawa cohort study of dementia |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2021/08/18 10:24:19 |
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Basic information
Public title
Aarakawa cohort study of dementia
Acronym
Arakawa 65+ study
Scientific Title
Aarakawa cohort study of dementia
Scientific Title:Acronym
Arakawa 65+ study
Region
| Japan |
Condition
Condition
dementia, depression
Classification by specialty
| Neurology | Psychosomatic Internal Medicine | Geriatrics |
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
early detection and examination exposure factors of dementia and depression of urban area in Japan
Basic objectives2
Others
Basic objectives -Others
incidence rate
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
onset of dementia and depression
Key secondary outcomes
cogunitive function
onset of caridiovascular disease
cause of death
physical function
nutorition
head MRI
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Resident of Arakawa ward, 65 year elder older and less than 85 year old, who agree to informed consent
Key exclusion criteria
none
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura |
Organization
Keio University school of Medicine
Division name
Department of Neuropsychiatry
Zip code
1608582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
0353633829
mimura@a7.keio.jp
Public contact
Name of contact person
| 1st name | Arakawa 65+ research staff |
| Middle name | |
| Last name | Arakawa 65+ research staff |
Organization
Keio University school of Medicine
Division name
Department of Neuropsychiatry
Zip code
1608582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
0353633971
Homepage URL
arakawakeio65@gmail.com
Sponsor or person
Institute
Central office of JPSC-AD, Kyushu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jananese Agency for Medical Research and Development: AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku ward, Tokyo
Tel
033353121162014
https://www.ctr.med.keio.ac.jp/forms/form_a.html
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
| 2016 | Year | 10 | 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
1099
Results
1) Kida H, Nakajima S, Shikimoto R et al: PCN.74(4),270-276,2020
2) Kobayashi N, Shinagawa S, Niimura H et al: Scientific Rep 10(1),1-8,2020
3) Ninomiya T, Nakaji S, Maeda T, et al: Environ Health Prev Med. 2020 31;25(1):64
Results date posted
| 2021 | Year | 02 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2035 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2035 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Not patecular
Management information
Registered date
| 2016 | Year | 08 | Month | 14 | Day |
Last modified on
| 2021 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027206
