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Neurotrack Test Validation Protocol

NCT ID: NCT02608021

Last Updated: 2019-12-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-01

Study Completion Date

2018-10-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mild Cognitive Impairment

Keywords

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Alzheimer's Disease MRI

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Amnestic mild cognitive impairment

No interventions assigned to this group

Cognitively normal

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Neurotrack Technologies, Inc.

INDUSTRY

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven H Ferris

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

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NYU Langone Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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14-00586

Identifier Type: -

Identifier Source: org_study_id