NCT07358598

Brief Summary

Dementia most commonly occurs in elderly individuals, but currently there is still a lack of objective measurement methods that can detect cognitive impairment in older adults at an early stage. Eye movement is considered a clinical indicator with potential for screening mild cognitive dysfunction, and eye movement signals can be extracted to objectively evaluate cognition. Eye tracking has been used mostly to evaluate patients with neurodegenerative diseases such as Parkinson's disease. However, less attention has been paid to the relationship between eye movement and cognitive function in elderly individuals, as well as the association between eye movement data and abnormal cognitive subdomains. This cross-sectional study will recruit 0204 elderly individuals over the age of 65, divided into three groups (healthy group/mild cognitive impairment group/dementia group) according to the purpose of this study. Participants who have not been diagnosed with neurological diseases (such as Parkinson's disease or stroke), or have mental illness or visual impairments will be excluded. This study hopes to provide empirical data on eye movement signals and cognitive function in healthy older individuals, as well as to serve as a preliminary study for future development of eye activity stimulation to improve cognitive function in older adults.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress32%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

January 5, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

January 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 5, 2026

Last Update Submit

January 22, 2026

Conditions

Keywords

Eye movementsCognitive function impairmentOlder adults

Outcome Measures

Primary Outcomes (1)

  • Eye-tracking measurement

    Eye movement behavior will be assessed as an objective measure of cognitive control in older adults. Eye-tracking data will be collected using the J7EF Gaze Smart Glasses (Jorjin Technologies), a non-invasive wearable eye-tracking system with a sampling frequency of 30 Hz. Participants will perform standardized visual tasks while eye movement behavior is recorded. Outcome measures will include task-related eye movement patterns, such as gaze behavior and saccadic performance, which reflect attentional control and higher-order cognitive processing. Alterations in these eye movement parameters have been associated with cognitive impairment. Eye movement measures will be used to characterize differences in cognitive function across participant groups.

    A single assessment is conducted at one study visit (cross-sectional design).

Secondary Outcomes (1)

  • Mini-Mental State Examination (MMSE)

    A single assessment is conducted at one study visit (cross-sectional design).

Other Outcomes (6)

  • Eye-Tracking Task 1: Horizontal Fixation Task (HFT)

    A single assessment is conducted at one study visit (cross-sectional design).

  • Eye-Tracking Task 2: Vertical Fixation Task (VFT)

    A single assessment is conducted at one study visit (cross-sectional design).

  • Eye-tracking Task 3: Horizontal Pursuit Task (HPT)

    A single assessment is conducted at one study visit (cross-sectional design).

  • +3 more other outcomes

Study Arms (3)

Healthy group-patients with intact cognitive function

Mild cognitive impairment group-patients with mild cognitive impairment

Dementia group-patients with severe cognitive impairment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 210 participants will be recruited, with an estimated 70 individuals in each cognitive group.

You may qualify if:

  • \- Participants are aged 65 years or older and have completed a comprehensive geriatric assessment (CGA) in the outpatient clinic.

You may not qualify if:

  • Participants are under 65 years of age or those who ar are unable to comply with study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Related Publications (1)

  • Pereira ML, Camargo Mv, Aprahamian I, Forlenza OV. Eye movement analysis and cognitive processing: detecting indicators of conversion to Alzheimer's disease. Neuropsychiatr Dis Treat. 2014 Jul 9;10:1273-85. doi: 10.2147/NDT.S55371. eCollection 2014.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Yen Chin CHEN, Associated professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 22, 2026

Study Start

January 17, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations