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
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