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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176704
• Other study ID #: ETNA-AD
• Status: Recruiting
• Start date: April 15, 2022
• Est. completion date: March 3, 2024

Study information

• Verified date: February 2024
• Source: Innodem Neurosciences
• Contact: Nancy Mugisha
• Phone: (514) 761-6131
• Email: nancy.mugisha.comtl[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 3, 2024
• Est. primary completion date: March 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	The Douglas Research Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Innodem Neurosciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline