Alzheimer's DiseaseNCT05176704
Development of Eye-movement Based Biomarkers in Alzheimer's Disease
An observational study of Alzheimer's Disease and Healthy Controls, run by McGill University at 5 sites in Canada.
Trial summary
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application. This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by Alzheimer's Disease and non-invasive eye movement measurements in response to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Healthy Controls
- What is being tested?
- Eye-Tracking
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 250 participants
- Where
- 5 sitesCanada
- Study dates
- 19 May 2026to 30 Nov 2027
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: For this study, we will recruit 250 participants. 125 will be AD patients (including predominant AD with mixed vascular and MCI due to AD), and 125 will be age-matched healthy cognitively intact control participants.
Who may be able to join
- For all participants:
- Able to provide informed consent
- Aged 18 years or older at the time of enrollment
- Able to read in either French or English
- Able to read the oculomotor task on-screen instructions at the testing distance (45cm) with or without corrective lenses.
- For patients only:
- Confirmed diagnosis of AD based on the NIAAA diagnostic criteria of probable AD
Who cannot join
- For AD participants:
- Diagnosed with one of the following dementia subtypes: Fronto-temporal dementia, Lewy-body dementia, or Creutzfeldt-Jakob disease.
- Incapacity to provide informed consent or inability to adequately understand the task instructions.
- For all participants:
- Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control.
- Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (strabismus, cranial nerve palsy, stroke-causing hemianopsia).
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- Diagnosis of macular edema or other pre-existing ocular conditions (e.g., glaucoma, cataracts) that would prevent from performing the eye movement assessments.
- Unstable medication use: recent (less than one month from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to have an effect on ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period of an eye movement assessment.
- Diagnosed with an active substance use disorder.
- History of stroke may be considered an exclusion criterion, at the discretion of the PI, if judged to potentially affect the cerebral network underlying eye movements and gaze control.
- Recent traumatic brain injury (within the last 6 months).
- For healthy controls only:
- Evidence or history of significant neurodegenerative disorder affecting brain function (e.g., MS, PD, ALS, Non-AD Dementia).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Elogia, a Residence of Groupe Maurice
Montreal, Quebec, H1V 1A1
Luciano Buonamici, 5143999016, luciano.buonamici@mcgill.ca
Simon Ducharme, MD MSc FRCP
- Not yet recruiting
ORA, A residence of Groupe Maurice
Montreal, Quebec, H2M 0A9
Luciano Buonamici, 514-399-9016, luciano.buonamici@mcgill.ca
Simon Ducharme, MD MSc FRCP
- Recruiting
Cornelius, a Residence of Groupe Maurice
Montreal, Quebec, H2Y 2H1
Luciano Buonamici, 514-399-9016, luciano.buonamici@mcgill.ca
Simon Ducharme, MD MSc FRCP
- Recruiting
The Douglas Research Centre
Montreal, Quebec, H4H 1R3
Cyrielle Talla, (514) 761-6131 ext. 4161, cyrielle.talla.comtl@ssss.gouv.qc.ca
Simon Ducharme, MD MSc FRCP
- Recruiting
The Montreal Neurological Institute
Ville-Marie, Quebec, H3A 2B4
Lydia Ouellet, 514-398-1445, lydia.ouellet@mcgill.ca
Simon Ducharme, MD MSc FRCP
About this study
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.
This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by Alzheimer's Disease and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of Alzheimer's Disease and associated cognitive changes.
- Conditions
- Alzheimer's Disease, Healthy Controls
- Being tested
- Eye-Tracking
- Keywords
- Alzheimer's Disease, Eye Movement Biomarkers, eye-tracking
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-TrackingDevice
Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's Patients | 125 participants will be AD patients (including predominant AD with mixed vascular and MCI due to AD) Receives: Device: Eye-Tracking | |
| Healthy Control | 125 Participant with no evidence or history of significant neurodegenerative disorder affecting brain function. Receives: Device: Eye-Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Dementia Rating (CDR) score, one time, at the day of enrollment.
The Clinical Dementia Rating (CDR) is a global rating scale for staging patients diagnosed with Alzheimer disease and other dementias and monitoring changes in the level of there disabilities over time. The CDR scale is a 0-3 point numeric scale (0.5 unit increments) derived from clinician rating of cognition and daily function in the domains of memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care.
Measured: Baseline
Secondary outcomes (2)
The Montreal Cognitive Assessment (MoCA) score, one time, at the day of enrollment.
The Montreal Cognitive Assessment (MoCA) is a brief 30-question cognitive screening test designed to assist Health Professionals in the detection of mild cognitive impairment and Alzheimer's disease. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.
Measured: Baseline
The Mini-Mental State Exam (MMSE) score, one time, at the day of enrollment.
The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly, it includes tests of orientation, attention, memory, language and visual-spatial skills. It consists of a series of questions and tests that can be used by clinicians to help diagnose dementia and to help assess its progression and severity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start19 May 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Ducharme, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176704
- Sponsor's protocol ID
- ETNA-AD
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2021
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Eye-movement Based Biomarkers in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05176704
- Acronym / sponsor ID
- ETNA-AD
- Conditions
- Alzheimer's Disease, Healthy Controls
- Keywords
- Alzheimer's Disease, Eye Movement Biomarkers, eye-tracking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 19 May 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 4 Jan 2022 (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.
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.
This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by Alzheimer's Disease and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of Alzheimer's Disease and associated cognitive changes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Patients | – | Device: Eye-Tracking125 participants will be AD patients (including predominant AD with mixed vascular and MCI due to AD) |
| Healthy Control | – | Device: Eye-Tracking125 Participant with no evidence or history of significant neurodegenerative disorder affecting brain function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For this study, we will recruit 250 participants. 125 will be AD patients (including predominant AD with mixed vascular and MCI due to AD), and 125 will be age-matched healthy cognitively intact control participants.
Key inclusion criteria (7 listed)
- For all participants:
- For patients only:
Key exclusion criteria (13 listed)
- For AD participants:
- For all participants:
- For healthy controls only:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye-TrackingEye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device. | Device | Alzheimer's Patients, Healthy Control |
Primary outcome
Clinical Dementia Rating (CDR) score, one time, at the day of enrollment.
Time frame: Baseline
The Clinical Dementia Rating (CDR) is a global rating scale for staging patients diagnosed with Alzheimer disease and other dementias and monitoring changes in the level of there disabilities over time. The CDR scale is a 0-3 point numeric scale (0.5 unit increments) derived from clinician rating of cognition and daily function in the domains of memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care.
2 secondary outcomes
The Montreal Cognitive Assessment (MoCA) score, one time, at the day of enrollment.
Time frame: Baseline
The Mini-Mental State Exam (MMSE) score, one time, at the day of enrollment.
Time frame: Baseline
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 14 Oct 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Healthy Controls, run by McGill University at 5 sites in Canada.
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 7 inclusion and 13 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 14 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 5 sites in Canada. 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 Luciano Buonamici (514-399-9016, luciano.buonamici@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Dementia Rating (CDR) score, one time, at the day of enrollment. (time frame: Baseline). 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 14 Oct 2026.