NCT04236375

Brief 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 of eye movement. Futher more, based on the screening results, the platform will offer referral suggestions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,539

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

April 13, 2026

Status Verified

January 1, 2020

Enrollment Period

4.9 years

First QC Date

January 18, 2020

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Area under the curve

    AUC values for predicting whether subject has cognitive impairment or not

    up to 1 month

Secondary Outcomes (1)

  • Accuracy, true positive rate, and true negetive rate

    up to 1 month

Study Arms (7)

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.

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who are over 45 years old with or without cognitive dysfunction.

You may qualify if:

  • 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

You may not qualify if:

  • ①Subjects who cannot do the inspection.
  • ②Subjects who suffer from diseases that compromise the inspection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Ocular Motility DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesCranial Nerve DiseasesEye DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Haotian Lin, M.D.,Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR
  • Xun Wang, M.D.,Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR
  • Shuyi Zhang, M.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2020

First Posted

January 22, 2020

Study Start

September 1, 2020

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

April 13, 2026

Record last verified: 2020-01

Locations