UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039287 |
|---|---|
| Receipt number | R000044806 |
| Scientific Title | Application of touch panel type visuospatial test to diagnosis of dementia |
| Date of disclosure of the study information | 2020/01/28 |
| Last modified on | 2021/01/28 10:15:02 |
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Basic information
Public title
Application of touch panel type visuospatial test to diagnosis of dementia
Acronym
Application of touch panel type visuospatial test to diagnosis of dementia
Scientific Title
Application of touch panel type visuospatial test to diagnosis of dementia
Scientific Title:Acronym
Application of touch panel type visuospatial test to diagnosis of dementia
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Alzheimer's disease
Healthy old adults
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare the touch panel type visuospatial test developed us with other general test (psychological test, driving aptitude test, EEG). The purpose of this study is to examine the relevance between tests and the simplicity of the touch panel type visuospatial test as screening for dementia and evaluation of driving ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Threshold of touch panel test
Key secondary outcomes
psychological test, driving aptitude test, EEG
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To record brain response using EEG
Interventions/Control_2
To record brain response using EEG
Interventions/Control_3
To record brain response using EEG
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
AD group:
1. Patients who are going to Kyushu University Hospital and outpatient clinic near Fukuoka and have confirmed AD
2 MMSE 21-23
3. Age 60 and over (regardless of gender)
4. Normal or corrected vision
5. Pearson who obtained written consent
MCI group:
1. Patients who are going to Kyushu University Hospital and outpatient clinic near Fukuoka and have confirmed MCI
2 MMSE 24-27
3. Age 60 and over (regardless of gender)
4. Normal or corrected vision
5. Pearson who obtained written consent
Control group:
1. Those who are not aware of forgetfulness and whose family members have not pointed.
2 MMSE 28-30
3. Age 60 and over (regardless of gender)
4. Normal or corrected vision
5. Pearson who obtained written consent
Key exclusion criteria
Patient and control groups:
1. Those who have a history of ophthalmic or neuropsychiatric disorder.
2. Any other person judged by the investigator to be inappropriate.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Yamasaki |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Clinical Neurophysiology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5542
yamasa@neurophy.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Yamasaki |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Clinical Neurophysiology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5542
Homepage URL
yamasa@neurophy.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel
092-642-5542
yamasa@neurophy.med.kyushu-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
| 2020 | Year | 01 | Month | 28 | 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
| 2019 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 04 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 04 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 04 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 28 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044806
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
