MCIVM-CogNCT06746844
ViewMind Atlas Cognition
A study testing ViewMind Atlas™ in people with MCI and Cognitive Ability, General, run by ViewMind at 1 site in Argentina.
Trial summary
The objective of this study is to demonstrate the clinical validity, analytical validity and safety of ViewMind Atlas as an adjunctive tool to be used by healthcare professionals (HCP) evaluating cognitive impairment in adults aged 45 to 95 years old. Read more about this study
- Who is it for?
- Ages 45 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- MCI, Cognitive Ability, General, Cognitive Decline
- What is being tested?
- ViewMind Atlas™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteArgentina
- Study dates
- 16 Oct 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following 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.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Ramos Mejía Hospital
Buenos Aires City, Buenos Aires, C1221ADC
About this study
Official title: A Comparative Study Between ViewMind AtlasTM, a Novel Digital Measure of Cognition, and Traditional Cognitive Tests
The objective of this study is to demonstrate the clinical validity, analytical validity and safety of ViewMind Atlas as an adjunctive tool to be used by healthcare professionals (HCP) evaluating cognitive impairment in adults aged 45 to 95 years old.
Read the detailed description
This will be a comparative study in which each subject undergoes testing by certified HCP evaluators administering the and ViewMind AtlasTM evaluation and the MoCA test, as well as additional tests, which are part of a reference standard neurocognitive battery of tests for cognition (WAT-BA, BEM-144, Rey Complex Figure Test, Wechsler Memory Scale subtests, WAIS III subtests, Trail Making Test A and B, Boston Naming Test, Phonological Verbal Fluency test, Semantic Verbal Fluency test, and Clock Drawing Test). Test-retest reliability of ViewMind AtlasTM will be conducted one week after initial testing.
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.
- 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.
- Correlation between the results obtained with ViewMind Atlas™ and the scores of each component of the MoCA test
- Correlation between the results obtained with ViewMind Atlas™ and the scores of each component of the neurocognitive test battery
- Regression analysis of test-retest reliability for ViewMind AtlasTM.
- 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
- MCI, Cognitive Ability, General, Cognitive Decline, Cognition
- Being tested
- ViewMind Atlas™
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViewMind Atlas™Device
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
| Study group | Role | What they receive |
|---|---|---|
| Cognitive assessment group | Experimental | All participants will undergo cognitive evaluation using VM Atlas and traditional tests Receives: Device: ViewMind Atlas™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of ViewMind Atlas™ in Identifying Cognitive Impairment
Evaluate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and likelihood ratios (positive and negative) of ViewMind Atlas™ compared to clinical diagnosis rendered by qualified providers using standard neuropsychological assessments.
Measured: At baseline (Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start16 Oct 2024
- Primary completion16 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViewMind
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- María B Eizaguirre, PhD, Study chair, Multiple Sclerosis University Center, Ramos Mejía Hospital, Buenos Aires, Argentina.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746844
- Sponsor's protocol ID
- ViewMindRM
- Acronym
- VM-Cog
- Status last verified
- Jul 2024
- First submitted
- 29 Nov 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between ViewMind AtlasTM, a Novel Digital Measure of Cognition, and Traditional Cognitive Tests
- ClinicalTrials.gov ID
- NCT06746844
- Acronym / sponsor ID
- VM-Cog / ViewMindRM
- Conditions
- MCI, Cognitive Ability, General, Cognitive Decline, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- ViewMindIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 16 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to demonstrate the clinical validity, analytical validity and safety of ViewMind Atlas as an adjunctive tool to be used by healthcare professionals (HCP) evaluating cognitive impairment in adults aged 45 to 95 years old.
Detailed description
This will be a comparative study in which each subject undergoes testing by certified HCP evaluators administering the and ViewMind AtlasTM evaluation and the MoCA test, as well as additional tests, which are part of a reference standard neurocognitive battery of tests for cognition (WAT-BA, BEM-144, Rey Complex Figure Test, Wechsler Memory Scale subtests, WAIS III subtests, Trail Making Test A and B, Boston Naming Test, Phonological Verbal Fluency test, Semantic Verbal Fluency test, and Clock Drawing Test). Test-retest reliability of ViewMind AtlasTM will be conducted one week after initial testing.
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.
- 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.
- Correlation between the results obtained with ViewMind Atlas™ and the scores of each component of the MoCA test
- Correlation between the results obtained with ViewMind Atlas™ and the scores of each component of the neurocognitive test battery
- Regression analysis of test-retest reliability for ViewMind AtlasTM.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive assessment group | Experimental | Device: ViewMind Atlas™All participants will undergo cognitive evaluation using VM Atlas and traditional tests |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following 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.
Key exclusion criteria (14 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Cognitive assessment group |
Primary outcome
Accuracy of ViewMind Atlas™ in Identifying Cognitive Impairment
Time frame: At baseline (Visit 1)
Evaluate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and likelihood ratios (positive and negative) of ViewMind Atlas™ compared to clinical diagnosis rendered by qualified providers using standard neuropsychological assessments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María B Eizaguirre, PhD study chair
Multiple Sclerosis University Center, Ramos Mejía Hospital, Buenos Aires, Argentina.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViewMind Atlas™ in people with MCI and Cognitive Ability, General, run by ViewMind at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of ViewMind Atlas™ in Identifying Cognitive Impairment (time frame: At baseline (Visit 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.