ViewMind Atlas Cognition

NCT06746844 | Enrolling By Invitation DMC

• 1 other identifier: ViewMindRM
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MCI; Cognitive Ability, General; Cognitive Decline; Cognition

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline (Visit 1)

Study Arms (1)

Cognitive assessment group

EXPERIMENTAL

All participants will undergo cognitive evaluation using VM Atlas and traditional tests

Device: ViewMind Atlas™

Interventions

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

Cognitive assessment group

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ViewMind: lead

Study Sites (1)

Ramos Mejía Hospital

Buenos Aires City, Buenos Aires, C1221ADC, Argentina

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• María B Eizaguirre, PhD

  Multiple Sclerosis University Center, Ramos Mejía Hospital, Buenos Aires, Argentina.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 24, 2024
• Study Start: October 16, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 31, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-07

Locations

AR (1)