UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044004
Receipt number R000050214
Scientific Title Research on the effects of dementia prevention projects
Date of disclosure of the study information 2021/04/21
Last modified on 2021/10/20 14:25:26

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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 or person

Institute

MCBI Inc.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050214


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name