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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039640
Receipt No. 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

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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
Email 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
Email sugmochi@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045208

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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