Evidence Amyloid Scan EEG Study

Study Overview
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Brief Summary
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The Evidence Amyloid Study EEG (EASE) establishes an open-label, longitudinal cohort study to measure of neurological functioning during the onset and progression of cognitive decline in preclinical Alzheimer's patients using quantitative electroencephalography (qEEG) measures (P300, P50, and reaction time). Participants will be scanned using the ElectroCap (FDA Class II) and/or the WAVi headset with the WAVi EEG P300/P50 system, along with the structured clinical interviews and assessments for baseline screening or mild cognitive impairment which are standard of care.

Detailed Description
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Obtain and analyze in-vivo EEG data in participants ages 50-65 showing early onset symptomology of MCI for the purpose of guiding patient management and developing intervention methods for improving overall health outcomes for this segment of the population. Both healthy and symptomatic groups will be populated by participants with previous PET amyloid-beta (Aβ) imaging scans. Incorporate WAVi brain scan technology which has proven effective in assessing cases of mTBI. Quantitative electroencephalograph (qEEG) is a non-invasive assessment which records multi-channel EEG event-related potentials (ERPs) and a comprehensive multi-dimensional analysis of such recordings by advanced algorithms aimed at understanding and visualizing the network complexity of brain function. Our goal is to compare assessments from both symptomatic and asymptomatic individuals to further develop differential diagnoses in the early-most stages of preclinical AD. Expounding upon an investigative technique that has shown promise in identifying region-specific abnormalities in concussed patients not only allows us to take advantage of an existing framework which provides a clear and elegant topographical output but also establishes a repeatable metric for quantifying MCI related dysfunction. Abiding by the measures within the existing framework contributes to a more standardized neurodiagnostic approach for dementia-related pathologies and supports continuity of care. Ultimately this neurophysiological assessment will shed new light on the progression of cognitive impairment and the response of developing therapeutic interventions for a variety of neurologic, psychiatric and behavioral conditions. The WAVi system uses algorithms and sets of signal processing and pattern recognition techniques to seek and map activated neural pathways in task-related data points with respect to time, location, amplitude, and frequency. By projecting the individual data points into clusters, they reveal three-dimensional images of brain network activation patterns which represent high resolution functional neural pathways. These brain network patterns and scores can aid clinicians with profiling of brain functionality in comparison to the reference brain network model to assess similarity to normal brain functioning. Measuring alterations in functionality and/or dysfunctionality can potentially assist treatment courses following changes in disease progression. When combined with data supplied from information from self-reported and observed cognitive and behavior patterns clarity arises with respect to brain processes and determination of the medical condition. For this investigation we will evaluate the ability of qEEG P300 and P50 waveform amplitudes and auditory response times to differentiate healthy aging individuals from those developing MCI characteristics. WAVi recording in the awake-responding state is an ideal low-cost and non-invasive methodology with a high temporal resolution (milliseconds) that provides an optimal investigational tool for the emerging features of brain pathophysiology. These procedures are well-tolerated by patients, unaffected by task difficulty and are widely available to all subpopulations, even those traditionally underrepresented in clinical study. Additionally, they can be repeated over time without habituation effects. Aim 1 determines individual baseline qEEG P300/P50 amplitudes and auditory response times in a population of healthy participants ages 50-65 without a history of dementia that have previously received PET scan imaging. Assess the population mean, median and variability. If possible, a subset will be retested at a standard interval to determine test-retest reliability for this instrument. Aim 2 evaluates the ability of qEEG P300 amplitudes and auditory response times to discriminate between aged participants with MCI/preclinical AD symptoms and healthy participants of similar age. Aim 3 evaluates the ability of qEEG P50 amplitudes to discriminate between aged participants with MCI/preclinical AD symptoms and healthy participants of similar age. Aim 4 confirms the efficacy of qEEG/amyloid plaque loading correlation with previous PET scan imaging data.

Official Title
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Quantitative EEG for Assessment of Mild Cognitive Impairment Associated With Preclinical Alzheimer's Disease - Evidence for Amyloid Indication Study

Conditions
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Alzheimer Disease, Dementia Frontal, Mild Cognitive Impairment

Intervention / Treatment
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* Device: EEG scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65 and older; Medicare beneficiary; Diagnosis of MCI or dementia, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months (American Psychiatric Association. 2000; McKhann et al. 2011; Albert et al. 2011); Cognitive complaint verified by objectively confirmed cognitive impairment; Alzheimer's disease is a diagnostic considerationExclusion Criteria: Head MRI and/or CT within 24 months prior to enrollment; Exclusion Criteria: Normal cognition or subjective complaints that are not verified by cognitive testing. Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family. Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening). Cancer requiring active therapy (excluding non-melanoma skin cancer); Life expectancy less than 24 months based on medical co-morbidities; Residence in a skilled nursing facility.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early stage of MCI symptoms<br>Subjects with cognitive decline representing MCI symptomology and with previous PET amyloid-beta (Aβ) imaging results. | Device: EEG scan<br>* WAVi EEG and evoked potential platform. Participants will be scanned using the ElectroCap (FDA Class II) and/or the WAVi Headset with the WAVi Co EEG P300 system, along with the structured clinical interviews and assessments for the various ailments or baseline screenings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient meeting Appropriate Use Criteria (AUC) with EEG brain scan - P300 and P50 will be measured for correlation between P300 and P50 with amyloid deposition. | Test whether qEEG P300 and P50 waveform amplitudes and auditory response times will lead to correlation with amyloid deposition | 10 days |