NCT05176704 · RECRUITING

Development of Eye-movement Based Biomarkers in Alzheimer's Disease

This study is testing an eye-tracking software tool. Participants take short thinking tests while a device records how their eyes move across a screen. Researchers will use the data to train computer programs to track changes linked to Alzheimer's. It is an early development study, not a treatment, and no phase is listed.

Eligibility criteria

Inclusion Criteria:
* For all participants:
  1. Able to provide informed consent
  2. Aged 18 years or older at the time of enrollment
  3. Able to read in either French or English
  4. Able to read the oculomotor task on-screen instructions at the testing distance (45cm) with or without corrective lenses.
* For patients only:
  1. Confirmed diagnosis of AD based on the NIAAA diagnostic criteria of probable AD
Exclusion Criteria:
* For AD participants:
  1. Diagnosed with one of the following dementia subtypes: Fronto-temporal dementia, Lewy-body dementia, or Creutzfeldt-Jakob disease.
  2. Incapacity to provide informed consent or inability to adequately understand the task instructions.
* For all participants:
  1. Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control.
  2. Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (strabismus, cranial nerve palsy, stroke-causing hemianopsia).
  3. Diagnosis of macular edema or other pre-existing ocular conditions (e.g., glaucoma, cataracts) that would prevent from performing the eye movement assessments.
  4. 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.
  5. Diagnosed with an active substance use disorder.
  6. 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.
  7. Recent traumatic brain injury (within the last 6 months).
* For healthy controls only:
  1. Evidence or history of significant neurodegenerative disorder affecting brain function (e.g., MS, PD, ALS, Non-AD Dementia).

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-10-14

View full record on ClinicalTrials.gov

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