UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037386 |
|---|---|
| Receipt number | R000042623 |
| Scientific Title | Developing a neurocognitive brain health programs to improve and strengthen cognitive abilities in elderly people. |
| Date of disclosure of the study information | 2019/07/16 |
| Last modified on | 2019/07/16 18:42:47 |
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Basic information
Public title
Developing a neurocognitive brain health programs to improve and strengthen cognitive abilities in elderly people.
Acronym
Developing a neurocognitive brain health programs to improve and strengthen cognitive abilities in elderly people.
Scientific Title
Developing a neurocognitive brain health programs to improve and strengthen cognitive abilities in elderly people.
Scientific Title:Acronym
Developing a neurocognitive brain health programs to improve and strengthen cognitive abilities in elderly people.
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is developing a brain health programs to improve and strengthen cognitive abilities in elderly people via physical exercise and cognitive training, or using artificial intelligence-based robot for facilitating communication activities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MMSE cognitive score after three-month interventions
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention: Facilitate communication activities using artificial intelligence-based robot
(once every two weeks, six times in total (three months))
Control: no intervention
Interventions/Control_2
Physical exercise with cognitive training
(no control group)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly people with or at a risk of developing mild cognitive impairment with the MMSE cognitive score of 16-28/30.
Key exclusion criteria
People with abnormalities in hearing, vision, or motor functions.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shuko |
| Middle name | |
| Last name | Takeda |
Organization
Osaka University School of Medicine
Division name
Clinical Gene Therapy
Zip code
565-0871
Address
2-2 Yamadaoka, Suita city, Osaka
TEL
0662108351
takeda@cgt.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuko |
| Middle name | |
| Last name | Takeda |
Organization
Osaka university School of Medicine
Division name
Clinical Gene Therapy
Zip code
565-0871
Address
2-2 Yamadaoka, Suita city, Osaka
TEL
0662108351
Homepage URL
takeda@cgt.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital
Address
2-2 Yamadaoka, Suita city, Osaka, 565-0871
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.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
| 2019 | Year | 07 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2019 | Year | 07 | Month | 16 | Day |
Last modified on
| 2019 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042623
| 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 |
