Neurotrack Test Validation Protocol

NCT02608021 | Completed

• 1 other identifier: 14-00586
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol describes a study to validate Neurotrack's visual paired comparison task, aimed at early detection and monitoring of memory impairment. The investigators will determine whether the novel task developed by Neurotrack is associated with markers of brain pathology associated with very early Alzheimer's disease. The elderly subjects studied will be cognitively normal (CN) or have amnestic mild cognitive impairment (aMCI). For the current study, the primary brain pathology parameters will be derived from MRI scans. Data from this study will be correlated with data from a parallel study designed to validate a larger group of new cognitive tasks by correlating test performance with a broader array of biomarkers of Alzheimer's disease.

Conditions

Mild Cognitive Impairment

Keywords

Alzheimer's Disease; MRI

Outcome Measures

Primary Outcomes (4)

• Presence of eye fixation assessed by a point of gaze continually remaining within 1 degree of visual angle for a period of 100 milliseconds or more.

  Eye fixation is defined as a point of gaze continually remaining within 1 degree of visual angle for a period of 100 milliseconds or more. Investigators will analyze the fixations that occur within 2 designated areas of interest (AOIs): the area of the novel image and the area of the familiar image.

  2 months

• Eye tracking data - Total looking time

  Total looking time (i.e. the total sum of the duration for all fixations)

  2 months

• Eye tracking data - Total number of fixations

  Total number of fixations (i.e. the total number of fixations that met the ≥100 ms criterion)

  2 months

• Eye tracking data - Percentage looking time

  Percentage looking time on novel image

  2 months

Secondary Outcomes (1)

• Correlation of MRI data with VPC task score

  2 months

Study Arms (2)

Amnestic mild cognitive impairment

Cognitively normal

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals will be recruited from among participants at the NYU Alzheimer's Disease Center ADC, at the affiliated Center for Brain Health (CBH), and from other ongoing NYU research studies of the Center for Cognitive Neurology (CCN) that are affiliated with the ADC and for which participants receive the standard ADC research diagnostic assessment (the ADC Clinical Evaluation).

You may qualify if:

• Clinical diagnosis based on recent (within 1 year) consensus meeting, cross-referenced with standard neuropsychological scores:
• Cognitively Normal (CN) Subjects: based on MMSE scores, CDR, and GDS.
• Amnestic Mild Cognitive Impairment (aMCI) Subjects: Diagnosis of aMCI, based on MMSE scores, CDR, and GDS.
• Normal or corrected-to-normal vision and hearing (able to see images on computer screen and hear auditory events delivered through the computer speaker).

You may not qualify if:

• Significant history of mental illness, drug or alcohol abuse; severe trauma preventing normal use of dominant hand (needed to move the mouse cursor); clinical depression (unless medically controlled); other neurologic conditions (i.e. stroke), or learning disability; ophthalmologic/visual problems that prevent viewing a computer screen at a normal distance (such as legal blindness, detached retinas, occlusive cataracts).
• Having pacemakers, aneurysm clips, cochlear implants, pulse oximeters, EKG leads, tattoos or other metal/foreign objects in body or face and therefore unable to receive MRI.
• Lack the capacity to give informed consent and lack of an authorized surrogate to provide consent if the prospective subject is found to lack adequate consent capacity.
• Pregnancy, breastfeeding or planning to have a baby.

Sponsors & Collaborators

• NYU Langone Health: lead
• Neurotrack Technologies, Inc.: collaborator

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Steven H Ferris

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 18, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 17, 2018
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

US (1)