UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048730 |
|---|---|
| Receipt number | R000055519 |
| Scientific Title | Verification of cognitive function improvement effect by "Brain training for living" app |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/08/24 09:33:14 |
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Basic information
Public title
Verification of cognitive function improvement effect by "Brain training for living" app
Acronym
Verification of cognitive function improvement effect by "Brain training for living" app
Scientific Title
Verification of cognitive function improvement effect by "Brain training for living" app
Scientific Title:Acronym
Verification of cognitive function improvement effect by "Brain training for living" app
Region
| Japan |
Condition
Condition
Normal
Classification by specialty
| Neurology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As a new means of preventing dementia, we will evaluate whether or not there is improvement in cognitive function using the "Dementia Prevention App" every day during the survey period.
Before and after using the "dementia prevention app," the cognitive function measurement scale described in the "primary endpoint" will be measured, and the cognitive function improvement effect of this app will be quantitatively evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The following cognitive function test results will be the primary endpoints
ADAS-Jcog
MMSE
HDS-R
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group using the "dementia prevention app"
Cognitive training of 12 questions for 15 minutes each time will be carried out with "Brain Training for Living" produced and developed by Nissay Information Technology Co., Ltd. three times a week.
Interventions/Control_2
"Healing music app" user group
Healing music is collected from free music on the Internet by Nissay Information Technology Co., Ltd. and listened to and listened to it three times a week for 15 minutes.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
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
Persons aged 65 and over who are open to the public
Key exclusion criteria
Those who are or are suspected to be certified as needing long-term care (requiring support)
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Asada |
Organization
Memory Clinic Ochanomizu
Division name
Medical Division
Zip code
113-0034
Address
Ochanomizu Medical Center 4F, 1-5-34 Yushima, Bunkyo-ku, Tokyo
TEL
03-6801-8718
asada@memory-cl.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Asada |
Organization
Memory Clinic Ochanomizu
Division name
Medical Division
Zip code
113-0034
Address
Ochanomizu Medical Center 4F, 1-5-34 Yushima, Bunkyo-ku, Tokyo
TEL
03-6801-8718
Homepage URL
asada@memory-cl.jp
Sponsor or person
Institute
Memory Clinic Ochanomizu
Institute
Department
Personal name
Funding Source
Organization
Nissay Information Technology Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Brain Functions Laboratory, Inc.
Address
The University of Tokyo/13F Hospital building B, 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
Tel
+81-3-3830-5700
ethics@bfl.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
メモリークリニックお茶の水（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 01 | 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
| 2022 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | 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
| 2022 | Year | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055519
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
