Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
270 participants
INTERVENTIONAL
2024-10-16
2024-12-31
Brief Summary
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Detailed Description
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Primary Objective:
● To assess the clinical validity of ViewMind Atlas for identifying cognitive impairment, as determined by MoCA
Secondary Objectives:
* To demonstrate the analytical validity of ViewMind Atlas for measuring cognition (evaluated) against an appropriate reference standard (MoCA)
* To examine the discriminant and convergence validity between ViewMind AtlasTM and a battery of neurocognitive tests in identifying cognitively healthy and cognitively impaired test subjects.
* To compare the test-retest reliability of ViewMind AtlasTM.
* To assess the safety of the ViewMind system.
1. Sensitivity (Se), Specificity (Sp) Negative Predictive Value (NPV), Positive Predictive Value (PPV) positive likelihood ratios, and negative likelihood ratios and Accuracy of ViewMind AtlasTM agreement with the classification of MoCA in identifying cognitively healthy and cognitively impaired test participants.
2. Correlation between the results obtained with ViewMind Atlas™ and the scores of each component of the MoCA test
3. Correlation between the results obtained with ViewMind Atlas™ and the scores of each component of the neurocognitive test battery
4. Regression analysis of test-retest reliability for ViewMind AtlasTM.
5. Collection of adverse events (AEs) Total no. of subjects: 327
* n= 128 for test-retest of ViewMind This study will be conducted in one site: Ramos Mejia Hospital, in Buenos Aires, Argentina.
This study is estimated to last 16 weeks, from start of enrollment to final data analysis.
All participants will attend at least a single visit during which the cognitive evaluations will be carried out. 128 participants will then come back for a second visit 1-3 weeks after the first visit, to undergo another cognitive evaluation with ViewMind.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Cognitive assessment group
All participants will undergo cognitive evaluation using VM Atlas and traditional tests
ViewMind Atlas™
The intervention involves the use of ViewMind Atlas™, a novel digital tool for cognitive assessment, and traditional cognitive tests. The ViewMind Atlas™ device evaluates cognitive performance through eye-tracking technology and advanced analytics, providing objective measurements of cognitive function. Traditional cognitive tests are used as the standard comparator to validate the device's diagnostic performance
Interventions
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ViewMind Atlas™
The intervention involves the use of ViewMind Atlas™, a novel digital tool for cognitive assessment, and traditional cognitive tests. The ViewMind Atlas™ device evaluates cognitive performance through eye-tracking technology and advanced analytics, providing objective measurements of cognitive function. Traditional cognitive tests are used as the standard comparator to validate the device's diagnostic performance
Eligibility Criteria
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Inclusion Criteria
* Male or female, aged between 45 and 95 years.
* Cohort 1: Presence of cognitive complaints and objectively measured cognitive impairment of an MMSE of \> 26, such as memory loss or other cognitive difficulties (60% of the overall study population). These complaints can be self-reported or noted by a close family member. Diagnosis of MCI by PI or delegated qualified provider on the study team.
* Cohort 2: Absence of cognitive complaints and absence of objectively measured cognitive impairment as determined by MMSE \> 26 and neuropsychological tests. Diagnosis of CN by PI or delegated qualified provider on the study team (40% of the overall study population).
* Willing to sign written informed consent and ability to comply with study requirements.
* Have adequate vision and hearing, with or without corrective devices, to ensure accurate self-reporting and comprehension of study materials.
Exclusion Criteria
* Participants with dementia, defined here as an MMSE of \< 25 and diagnosis of cognitive decline that is not MCI but more severe in nature by the PI or delegated qualified provider on the study team.
* Advanced, severe progressive or unstable disease that may interfere with the safety, tolerability and study assessments, or put the participant at special risk as judged by the investigator.
* Subjects who had received an investigational drug or therapy within 30 days or 5 half-lives, whichever was longer, of the first visit.
* Participants with glaucoma, cataract, macular degeneration in both eyes, or any other cause of uncorrected visual impairment (less than 20/30).
* Participants with severe color-blindness.
* Participants with developmental cognitive dysfunction (congenital, pediatric).
* Major psychiatric disorder (e.g., chronic psychosis, recurrent depressive disorder, generalized anxiety disorder).
* Use of cognitive enhancing drugs (e.g., cholinesterase inhibitors).
* A concurrent diagnosis of epilepsy.
* History of alcohol misuse and/or illicit drug use.
* History of acute damage, including stroke, traumatic brain injury, tumors, etc.
* Presence of sleep apnea.
* Recent participation in another neuropsychological study.
45 Years
95 Years
ALL
Yes
Sponsors
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ViewMind
INDUSTRY
Responsible Party
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Principal Investigators
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María B Eizaguirre, PhD
Role: STUDY_CHAIR
Multiple Sclerosis University Center, Ramos Mejía Hospital, Buenos Aires, Argentina.
Locations
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Ramos Mejía Hospital
Buenos Aires City, Buenos Aires, Argentina
Countries
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Other Identifiers
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ViewMindRM
Identifier Type: -
Identifier Source: org_study_id