UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047322 |
|---|---|
| Receipt number | R000053974 |
| Scientific Title | Evaluation of cognitive function of elderly people using tablet devices |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/03/31 10:24:11 |
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Basic information
Public title
Evaluation of cognitive function of elderly people using tablet devices
Acronym
Evaluation of cognitive function of elderly people using tablet devices
Scientific Title
Evaluation of cognitive function of elderly people using tablet devices
Scientific Title:Acronym
Evaluation of cognitive function of elderly people using tablet devices
Region
| Japan |
Condition
Condition
Healthy elderly subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the possibility of introducing cognitive function assessment with tablet devices for evaluation of the food intake effect on cognitive function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TDAS, Cognitive function assessment device with line of sight, MMSE, MoCA, Plasma BDNF concentration, Plasma NGF concentration, Plasma omega 3-fatty acids concentration (DHA and EPA), Plasma DHA concentration, Plasma EPA concentration, CRP concentration, Lean body mass, BMI, SMI, Subjective health status, Frequency of going out
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects giving written informed consent
2) Subjects who participate in the clinical trial (UMIN ID: UMIN000044496)
3) Participants in the project for evaluation of cognitive function using tablet devices in Obihiro City, Hokkaido
Key exclusion criteria
None
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakamura |
Organization
Meiji Co., Ltd.
Division name
R & D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
+81-42-632-5846
kentarou.nakamura@meiji.com
Public contact
Name of contact person
| 1st name | Yoshimura |
| Middle name | |
| Last name | Aya |
Organization
Meiji Co., Ltd.
Division name
R & D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
+81-42-632-5846
Homepage URL
aya.yoshimura.aa@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachiouji, Tokyo
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
| 2022 | Year | 04 | 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
72
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 | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To estimate the effects of food intake on cognitive function using cognitive function assessment using tablet devices.
Management information
Registered date
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053974
