Cognitive DysfunctionNCT07358598
Eye Movement Parameters and Cognitive Functions in Older Adults
An observational study of Cognitive Dysfunction, run by National Sun Yat-sen University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction
- How many people
- 210 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2026to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: A total of 210 participants will be recruited, with an estimated 70 individuals in each cognitive group.
Who may be able to join
- Participants are aged 65 years or older and have completed a comprehensive geriatric assessment (CGA) in the outpatient clinic.
Who cannot join
- Participants are under 65 years of age or those who ar are unable to comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City
About this study
Official title: The Relationship Between Eye Movement Parameters and Cognitive Functions in Older Adults
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.
- Conditions
- Cognitive Dysfunction
- Keywords
- Eye movements, Cognitive function impairment, Older adults
- Medical subject headings
- 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 |
|---|---|---|
| Healthy group-patients with intact cognitive function | Not described | |
| Mild cognitive impairment group-patients with mild cognitive impairment | Not described | |
| Dementia group-patients with severe cognitive impairment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A single assessment is conducted at one study visit (cross-sectional design).
Secondary outcomes (1)
Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) is a widely used cognitive screening tool originally developed by Folstein and McHugh in 1975 (Folstein et al., 1975). It consists of 30 items assessing six domains of cognitive function: orientation, attention, memory, language, verbal comprehension, praxis, and constructional ability. Higher scores indicate better cognitive function. A total score between 24 and 30 suggests intact cognitive function; scores between 18 and 23 are indicative of mild cognitive impairment; and scores from 0 to 17 reflect moderate to severe cognitive impairment.
In the present study, the MMSE is used to classify adults aged 65 years and older into cognitive status groups, including a cognitively healthy group, a mild cognitive impairment (MCI) group, and a dementia group, based on established score thresholds.
Measured: A single assessment is conducted at one study visit (cross-sectional design).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358598
- Sponsor's protocol ID
- KSVGH24-CT10-11
- Status last verified
- Oct 2026
- First submitted
- 5 Jan 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25031536
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Eye Movement Parameters and Cognitive Functions in Older Adults
- ClinicalTrials.gov ID
- NCT07358598
- Acronym / sponsor ID
- KSVGH24-CT10-11
- Conditions
- Cognitive Dysfunction
- Keywords
- Eye movements, Cognitive function impairment, Older adults
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- National Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy group-patients with intact cognitive function | – | – |
| Mild cognitive impairment group-patients with mild cognitive impairment | – | – |
| Dementia group-patients with severe cognitive impairment | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- A total of 210 participants will be recruited, with an estimated 70 individuals in each cognitive group.
Key inclusion criteria (1 listed)
- Participants are aged 65 years or older and have completed a comprehensive geriatric assessment (CGA) in the outpatient clinic.
Key exclusion criteria (1 listed)
- Participants are under 65 years of age or those who ar are unable to comply with study procedures.
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
Eye-tracking measurement
Time frame: A single assessment is conducted at one study visit (cross-sectional design).
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.
1 secondary outcome
Mini-Mental State Examination (MMSE)
Time frame: A single assessment is conducted at one study visit (cross-sectional design).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Results publication: PubMed 25031536Pereira 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.
- Individual participant dataSharing planned: No
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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.
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 Cognitive Dysfunction, run by National Sun Yat-sen University at 1 site in Taiwan.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Oct 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yen Chin CHEN, Associated professor (+886 7 5252000#7374, yenchin2427@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye-tracking measurement (time frame: A single assessment is conducted at one study visit (cross-sectional design).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07358598, which also lists 1 linked publication.
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 15 Oct 2026.