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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039287
Receipt No. 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

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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
Email 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
Email yamasa@neurophy.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044806

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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