Development of a new eye-tracking software for Alzheimer's Disease

Development and Validation of a Novel Functional Eye-Tracking Software Application for Alzheimer's Disease

This study is testing a new eye-tracking software to see if it can help measure brain function changes in people with Alzheimer's Disease.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innodem Neurosciences (Industry-sponsored)
• Locations: 1 site (Montréal, Quebec)
• Trial ID: NCT05176704 on ClinicalTrials.gov

What this trial studies

This study focuses on creating and validating a non-invasive eye-tracking software application designed to assess cognitive functions affected by Alzheimer's Disease. Participants will undergo brief cognitive tests alongside eye movement measurements in response to visual stimuli during specialized eye-tracking assessments. The collected data will be utilized to develop machine learning algorithms aimed at tracking the progression of Alzheimer's Disease and its associated cognitive changes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of Alzheimer's Disease who can provide informed consent.

Not a fit: Patients with other types of dementia or those unable to understand task instructions may not benefit from this study.

Why it matters

Potential benefit: If successful, this software could provide a new tool for early detection and monitoring of cognitive decline in Alzheimer's patients.

How similar studies have performed: While the approach of using eye-tracking for cognitive assessment is promising, this specific application is novel and has not been extensively tested in prior studies.

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. Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc. are permitted)
* For patients only:

  1. Confirmed diagnosis of AD based on the NIAAA diagnostic criteria of probable AD
  2. Having undergone a full neuropsychological evaluation within the last 6 months or having a planned full neuropsychological evaluation within the next 6 months.
  3. AD diagnoses supported by FDG-PET scan or amyloid biomarkers (CSF or amyloid PET)

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.
  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)

Where this trial is running

Montréal, Quebec

• The Douglas Research Centre — Montréal, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Nancy Mugisha

Conditions Alzheimer's Disease; Eye Movement Biomarkers; eye-tracking