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	Adult
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Awareness findings MCI screening test
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Exercise program for seniors (once a week, for 1.5h) 6 times.
Interventions/Control_2	Music reminiscence program (once a week, for 1h) 6 times.
Interventions/Control_3	Music reminiscence and brain training program (once a week, for 1h+15m) 6 time.
Interventions/Control_4	Reading aloud program (once a week, for 1h) 6 times.
Interventions/Control_5	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. Those who have received sufficient explanation about the purpose and contents of this research, have the ability to consent, volunteered voluntarily after fully understanding it, and agreed to participate in writing. 2. Japanese men and women who are 65 years old or more. 3. Those who are always interested in dementia prevention and would like to participate in the prevention project
Key exclusion criteria	1. Those who have a chronic illness and are receiving drug treatment, those who have a history of serious illness. 2. Those who regularly use medicines, specified insurance foods and/or health foods, etc. that may affect the prevention of dementia. 3. Those who participated in other exams within one month before the start of this reseach, or those who plan to participate in other exams after consenting to this research. 4. Those who are judged to be ineligible by the principal investigator
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	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	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	self funding
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	Ethics committee of MCBI Inc.
Address	Azuma 3-15-15 Tsukuba Ibaraki, JAPAN Okaba Tsukuba Bild. 3F
Tel	029-855-5071
Email	h.suzuki@mcbi.co.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 04 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	Completed
Date of protocol fixation	2021 Year 04 Month 12 Day
Date of IRB	2021 Year 04 Month 21 Day
Anticipated trial start date	2021 Year 04 Month 22 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

Management information
Registered date	2021 Year 04 Month 21 Day
Last modified on	2021 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050214