UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043082 |
|---|---|
| Receipt number | R000049185 |
| Scientific Title | Research on the effects of dementia prevention projects |
| Date of disclosure of the study information | 2021/01/21 |
| Last modified on | 2021/04/30 11:28:14 |
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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
| 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
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
info@mcbi.co.jp
Sponsor or person
Institute
MCBI Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049185
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
