UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039640 |
|---|---|
| Receipt number | R000045208 |
| Scientific Title | Early detection of dementia by retinal construction and functional evaluation |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2020/02/28 19:31:01 |
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Basic information
Public title
Early detection of dementia by retinal construction and functional evaluation
Acronym
Early detection of dementia by retinal construction and functional evaluation
Scientific Title
Early detection of dementia by retinal construction and functional evaluation
Scientific Title:Acronym
Early detection of dementia by retinal construction and functional evaluation
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether non-invasive retinal construction and retinal function evaluation can be applied to predict the onset of dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in retinal construction and retinal function between groups
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
AD and MCI due to AD are diagnosed at our department of neurology based on the results of neuropsychological and brain imaging tests performed on patients by interviews with their families.
Key exclusion criteria
Glaucoma
optic nerve atrophy
Anterior segment difficult to see through the fundus, opacity of intermediate translucent body (corneal opacity, strong cataract, vitreous opacity, etc.)
A history of retinal diseases such as diabetic retinopathy, age-related macular degeneration, retinal detachment, and vitreous surgery
Strong myopia, long-axis long-eye
History of visual field disorder due to central illness such as cerebral infarction
Artificial aphakic eye
Patients who are judged inappropriate by the principal investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University Hospital
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174Edobashi, Tsu, Mie
TEL
059-232-1111
sugmochi@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University Hospital
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174Edobashi, Tsu, Mie
TEL
059-232-1111
Homepage URL
sugmochi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie University
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
Mie University Hospital
Address
2-174Edobashi, Tsu, Mie
Tel
059-232-1111
sugmochi@clin.medic.mie-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 | 05 | 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
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
| 2020 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045208
| Research Plan | |
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| 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 |
