UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054419 |
|---|---|
| Receipt number | R000062120 |
| Scientific Title | A study on cognitive function testing methods using automated voice guidance |
| Date of disclosure of the study information | 2024/05/17 |
| Last modified on | 2024/12/27 08:56:04 |
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Basic information
Public title
A study on cognitive function testing methods using automated voice guidance
Acronym
A study on cognitive function testing methods using automated voice guidance
Scientific Title
A study on cognitive function testing methods using automated voice guidance
Scientific Title:Acronym
A study on cognitive function testing methods using automated voice guidance
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct and evaluate the performance of a machine learning model that classifies between normal cognition and cognitive decline corresponding to mild cognitive impairment(MCI) or dementia.
Basic objectives2
Others
Basic objectives -Others
To evaluate the performance of a machine learning model that classifies between normal cognition and MCI or dementia, or between CDR0 and CDR0.5 or CDR1 or higher.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The accuracy of the constructed machine learning model in classification between normal cognition and MCI or dementia, or between CDR0 and CDR0.5 or CDR1 or higher.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Neuropsychological tests
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who have been fully informed about the study and have voluntarily provided written consent after fully understanding the details.
Subjects for whom written consent has been obtained from a proxy, as physicians have determined that valid informed consent cannot be directly obtained from the subjects themselves.
Subjects who are capable of undergoing the examination.
Key exclusion criteria
Subjects who have been deemed inappropriate for participation in this study by the principal investigator or other researchers.
Subjects who have expressed a desire to withdraw their consent.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Setsuo |
| Middle name | |
| Last name | Kinoshita |
Organization
Nippontect Systems co.,ltd
Division name
Medical Solution Department
Zip code
150-0043
Address
Shibuya Mark City West 16F, 1-12-1 Dogenzaka, Shibuya-ku, Tokyo
TEL
03-6452-9893
s.kinoshita@nippontect.co.jp
Public contact
Name of contact person
| 1st name | Setsuo |
| Middle name | |
| Last name | Kinoshita |
Organization
Nippontect Systems co.,ltd
Division name
Medical Solution Department
Zip code
150-0043
Address
Shibuya Mark City West 16F, 1-12-1 Dogenzaka, Shibuya-ku, Tokyo
TEL
03-6452-9893
Homepage URL
s.kinoshita@nippontect.co.jp
Sponsor or person
Institute
Nippontect Systems co.,ltd
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asai Dermatology Clinical Trial Review Committee
Address
3-4-8 Hatchobori, Chuo-ku, Tokyo
Tel
03-5543-0196
jimukyoku@smo-msr.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
| 2024 | Year | 05 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 17 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062120
