UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051764 |
|---|---|
| Receipt number | R000059079 |
| Scientific Title | Association between Retinal Structure Pattern Classification via Machine Learning and Cognitive Functions |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/07/31 16:54:44 |
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Basic information
Public title
Association between Retinal Structure and Cognitive Functions
Acronym
Association between Retinal Structure and Cognitive Functions
Scientific Title
Association between Retinal Structure Pattern Classification via Machine Learning and Cognitive Functions
Scientific Title:Acronym
Association between Retinal Structure and Cognitive Functions
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Ophthalmology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan's aging society, dementia prevalence is rising rapidly, with Alzheimer's Disease (AD), making up 70% of cases. Although AD, characterized by amyloid-beta deposition in the brain, is a progressive degenerative disease, early intervention can halt its progression. Detecting AD early, especially in its precursor stage when cognitive functions remain normal, is crucial. Retinal Optical Coherence Tomography (OCT) is a non-invasive test widely used in general ophthalmology and glaucoma screenings. Recent studies indicate reduced retinal thickness in dementia and AD patients, even in early stages.
Our research aims to use machine learning on OCT data to identify retinal patterns linked to cognitive functions and establish an early dementia screening method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cognitive function score (MSP-1100)
Key secondary outcomes
age
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
| 40 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Approximately 8,000 cases from 2017 to 2022 who visited the Hitachi Health Management Center and underwent retinal OCT examinations (Maestro; TOPCON) and cognitive function tests (MSP-1100; Nihon Kohden).
Key exclusion criteria
History of retinal and optic nerve diseases.
Target sample size
8000
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Fukai |
Organization
Tokai university
Division name
preventive medicine
Zip code
259-1193
Address
Isehara, Shimokasuya 143
TEL
08056680229
kota229@tsc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Fukai |
Organization
Tokai university
Division name
preventive medicine
Zip code
259-1193
Address
Isehara, Shimokasuya 143
TEL
08056680229
Homepage URL
kota229@tsc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai university
Institute
Department
Personal name
Funding Source
Organization
KAKENHI grant
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
Tokai university
Address
Isehara, Shimokasuya 143
Tel
08056680229
kota229@tsc.u-tokai.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
| 2023 | Year | 08 | 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
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2023 | Year | 07 | Month | 31 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059079
