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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
