Recruiting

Functional Eye-Tracking

Sponsor:

Innodem Neurosciences

Code:

NCT05176704

Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Eye-Tracking

Study Details

Brief 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 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

Study ID

NCT05176704

Start date

Apr 15, 2022

Status verified date

Feb, 2024

Completion date

Mar 3, 2024

Anticipated

Primary completion date

Mar 3, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

CDR = 0.5

50 Alzheimer's Disease (AD) patients including predominant AD with mixed vascular and MCI due to AD based on their CDR score. Questionable/very mild dementia (CDR = 0.5)

CDR = 1

50 Alzheimer's Disease (AD) patients including predominant AD with mixed vascular and MCI due to AD based on their CDR score. Mild dementia/MCI (CDR = 1)

CDR = 2

50 Alzheimer's Disease (AD) patients including predominant AD with mixed vascular and MCI due to AD based on their CDR score. Moderate dementia (CDR = 2)

CDR = 3

50 Alzheimer's Disease (AD) patients including predominant AD with mixed vascular and MCI due to AD based on their CDR score. Severe dementia (CDR = 3)

Healthy Control

50 Participant with no evidence or history of significant neurodegenerative disorder affecting brain function.

Interventions

Eye-Tracking

Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

Primary outcome measure

  • Clinical Dementia Rating (CDR) score, one time, at the day of enrollment. [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

The Douglas Research Centre

Recruiting

Montréal, Quebec, Canada, H4H 1R3

Contacts

Principal Investigator:

Simon Ducharme

More Information

Sponsor

Innodem Neurosciences

Last update posted

Feb 13, 2024

Last verified

Feb, 2024

Keywords

  • Alzheimer's Disease
  • Eye Movement Biomarkers
  • eye-tracking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Innodem Neurosciences on 2024-02-13.