UMIN-CTR Clinical Trial

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
Email	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
Email	arakawakeio65@gmail.com

Sponsor
Institute	Central office of JPSC-AD, Kyushu University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027206