Neurotrack Test Validation Protocol

Mild Cognitive Impairment Clinical Trial

Official title:

Neurotrack Test Validation Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608021
• Other study ID #: 14-00586
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: October 17, 2018

Study information

• Verified date: December 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The Neurotrack test has the potential to dramatically alter the current methods used for detecting cognitive deficits. Patients and research subjects could be screened for medial temporal lobe (MTL) impairment using inexpensive, widely available, safe, and non-invasive technology.

Subjects will be elderly individuals who are participating in ongoing research at the NYU Alzheimer's Disease Center (ADC) and who have received the standard ADC clinical evaluation within the past year, including a medical-neurological evaluation, neuro-psychological assessment and structural neuroimaging (MRI). As part of the current study, all subjects will receive both the Neurotrack Visual Paired-Comparison (VPC) Task and MRI scans. The current protocol strictly for a research study and there will be no "standard care" provided. Participants will be asked to come in for two separate sessions. The first session will involve screening to confirm eligibility and administration of the cognitive testing procedures, while the second session will involve the MRI protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 17, 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Normal or corrected-to-normal vision and hearing (able to see images on computer screen and hear auditory events delivered through the computer speaker).

Exclusion Criteria:

1. 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).

2. 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.

3. 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.

4. Pregnancy, breastfeeding or planning to have a baby.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	NeuroTrack Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Eye tracking data - Total looking time	Total looking time (i.e. the total sum of the duration for all fixations)	2 months
Primary	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
Primary	Eye tracking data - Percentage looking time	Percentage looking time on novel image	2 months
Secondary	Correlation of MRI data with VPC task score		2 months