UMIN-CTR Clinical Trial

Basic information
Public title	Research on the effects of dementia prevention projects
Acronym	Research on the effects of dementia prevention projects
Scientific Title	Research on the effects of dementia prevention projects
Scientific Title:Acronym	Research on the effects of dementia prevention projects
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of various dementia prevention projects using MCI screening test.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MCI screening test ( Grade, MCI risk value, APOA1, TTR, C3 )
Key secondary outcomes	Score of MCI screening test after brain training with CogEvo

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Carry out exercise program for seniors (once a week, for 1.5h) 6 times.
Interventions/Control_2	Carry out music reminiscence program (once a week, for 1h) 6 times.
Interventions/Control_3	Carry out music reminiscence and brain training program (once a week, for 1h+15m) 6 times.
Interventions/Control_4	Carry out reading aloud program (once a week, for 1h) 6 times.
Interventions/Control_5	Carry out reading aloud and brain training program (once a week, for 1h+15m) 6 times.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Japanese who are 65 years old or more
Key exclusion criteria	1.Persons who have chronic illness, receiving medication, have a serious disease history 2.Persons who regularly use medicines, specified health foods, health foods that may affect the prevention of dementia 3.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 4.Persons who were judged as inappropriate for study participants by the principal investigator 5.Persons who are pregnant, planning or hoping to be pregnant during the study period, currently lactating
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yoshihisa Middle name Last name Tokumi
Organization	MCBI Inc.
Division name	Company director
Zip code	102-0072
Address	Hikari Bld. 4F, 2-14-7 Iidabashi,Chiyoda-ku, Tokyo, JAPAN
TEL	03-5772-1486
Email	info@mcbi.co.jp

Public contact
Name of contact person	1st name Yoshihisa Middle name Last name Tokumi
Organization	MCBI Inc.
Division name	Company director
Zip code	102-0072
Address	Hikari Bld. 4F, 2-14-7 Iidabashi,Chiyoda-ku, Tokyo, JAPAN
TEL	03-5772-1486
Homepage URL
Email	info@mcbi.co.jp

Sponsor
Institute	MCBI Inc.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel	03-6809-2722
Email	soumu@hc-sys.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

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	Terminated
Date of protocol fixation	2021 Year 01 Month 12 Day
Date of IRB	2021 Year 01 Month 12 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study was registered and published in UMIN00004400 on April 21, 2021 due to change in the research system, so please refer to UMIN000044004 for details and progress (described on March 24, 2020).

Management information
Registered date	2021 Year 01 Month 21 Day
Last modified on	2021 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049185