Eye Movement DisorderEMCDNCT04236375
Eye Movement and Cognitive Dysfunction
An observational study of Eye Movement Disorder and Cognitive Dysfunction, run by Sun Yat-sen University at 1 site in China.
Trial summary
There is association between eye movement disorder and cognitive dysfunction. Therefore, utilizing eye movement and screening for cognitive dysfunction is feasible. In the present study, the investigators will develop an artificial intelligence platform to screening for cognitive dysfunction by inspecting the function… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Movement Disorder, Cognitive Dysfunction
- How many people
- 1,539 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who are over 45 years old with or without cognitive dysfunction.
Who may be able to join
- ①Subjects who are diagnosed as mild cognitive decline, Alzheimer's disease, Vascular dementia, Lewy body dementia, Frontotemporal dementia, other dementia and normal by neurologist.
- ②Subjects who can cooperate with the inspection.
- ③Subjects who agree to participate in the study and sign the consent form
Who cannot join
- ①Subjects who cannot do the inspection.
- ②Subjects who suffer from diseases that compromise the inspection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development of an Artificial Intelligence Platform for Screening and Referral of Cognitive Dysfunction
There is association between eye movement disorder and cognitive dysfunction. Therefore, utilizing eye movement and screening for cognitive dysfunction is feasible. In the present study, the investigators will develop an artificial intelligence platform to screening for cognitive dysfunction by inspecting the function of eye movement. Futher more, based on the screening results, the platform will offer referral suggestions.
- Conditions
- Eye Movement Disorder, Cognitive Dysfunction
- Medical subject headings
- Ocular Motility Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal | Subjects over 45 years old without cognitive dysfunction | |
| Mild cognitive decline | Subjects who are diagnosed as mild cognitive decline(MCI) according to neurologists. | |
| Alzheimer's disease | Subjects who are diagnosed as Alzheimer's disease(AD) according to neurologists. | |
| Vascular dementia | Subjects who are diagnosed as vascular dementia(VD) according to neurologists. | |
| Lewy body dementia | Subjects who are diagnosed as Lewy body demenita (DLB) according to neurologists. | |
| Frontotemporal dementia | Subjects who are diagnosed as Frontotemporal demenita (FD) according to neurologists. | |
| Other dementia | Subjects who are diagnosed as dementia but are not as AD, VD, DLB OR FD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve
AUC values for predicting whether subject has cognitive impairment or not
Measured: up to 1 month
Secondary outcomes (1)
Accuracy, true positive rate, and true negetive rate
The performance of this artificial platform
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Sep 2020
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye Movement DisorderStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 1,539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, M.D.,Ph.D, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityXun Wang, M.D.,Ph.D, Study director, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityShuyi Zhang, M.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236375
- Sponsor's protocol ID
- Eye movement-cognitive decline
- Acronym
- EMCD
- Status last verified
- Jan 2020
- First submitted
- 18 Jan 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of an Artificial Intelligence Platform for Screening and Referral of Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT04236375
- Acronym / sponsor ID
- EMCD / Eye movement-cognitive decline
- Conditions
- Eye Movement Disorder, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,539 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is association between eye movement disorder and cognitive dysfunction. Therefore, utilizing eye movement and screening for cognitive dysfunction is feasible. In the present study, the investigators will develop an artificial intelligence platform to screening for cognitive dysfunction by inspecting the function of eye movement. Futher more, based on the screening results, the platform will offer referral suggestions.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –Subjects over 45 years old without cognitive dysfunction |
| Mild cognitive decline | – | –Subjects who are diagnosed as mild cognitive decline(MCI) according to neurologists. |
| Alzheimer's disease | – | –Subjects who are diagnosed as Alzheimer's disease(AD) according to neurologists. |
| Vascular dementia | – | –Subjects who are diagnosed as vascular dementia(VD) according to neurologists. |
| Lewy body dementia | – | –Subjects who are diagnosed as Lewy body demenita (DLB) according to neurologists. |
| Frontotemporal dementia | – | –Subjects who are diagnosed as Frontotemporal demenita (FD) according to neurologists. |
| Other dementia | – | –Subjects who are diagnosed as dementia but are not as AD, VD, DLB OR FD. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are over 45 years old with or without cognitive dysfunction.
Key inclusion criteria (3 listed)
- ①Subjects who are diagnosed as mild cognitive decline, Alzheimer's disease, Vascular dementia, Lewy body dementia, Frontotemporal dementia, other dementia and normal by neurologist.
- ②Subjects who can cooperate with the inspection.
- ③Subjects who agree to participate in the study and sign the consent form
Key exclusion criteria (2 listed)
- ①Subjects who cannot do the inspection.
- ②Subjects who suffer from diseases that compromise the inspection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area under the curve
Time frame: up to 1 month
AUC values for predicting whether subject has cognitive impairment or not
1 secondary outcome
Accuracy, true positive rate, and true negetive rate
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haotian Lin, M.D.,Ph.D study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
Xun Wang, M.D.,Ph.D study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
Shuyi Zhang, M.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Movement Disorder and Cognitive Dysfunction, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.