Neurotrack Test Validation Protocol
| Status: | Recruiting |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - 85 |
| Updated: | 1/31/2019 |
| Start Date: | October 1, 2015 |
| End Date: | September 2019 |
| Contact: | Anaztasia H Ulysse |
| Email: | sAnaztasia.Ulysse@nyulangone.org |
| Phone: | (212)-263-0771 |
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.
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.
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.
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.
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.
We found this trial at
1
site
New York, New York 10016
Principal Investigator: Martin Sadowski, MD
Phone: 212-263-0771
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