Evidence Amyloid Scan EEG Study

NCT ID: NCT03644043

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-20
• Study Completion Date: 2020-11-30

Brief Summary

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

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.

Conditions

Alzheimer Disease; Dementia Frontal; Mild Cognitive Impairment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early stage of MCI symptoms

Subjects with cognitive decline representing MCI symptomology and with previous PET amyloid-beta (Aβ) imaging results.

EEG scan

Intervention Type: DEVICE

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

Interventions

EEG scan

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

Intervention Type: DEVICE

Eligibility Criteria

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;

Exclusion Criteria

• Head MRI and/or CT within 24 months prior to enrollment;

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Asian American Adult Development

UNKNOWN

Sponsor Role: collaborator

Metabolic Therapy Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Translational Cognitive Research

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dewey Brown II, PhD

Role: CONTACT

kruss3@gmail.com

2145174004

Kenneth O Russell

Role: CONTACT

kruss3@gmail.com

5129097963

Facility Contacts

Dewey Brown II, PhD

Role: primary

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Other Identifiers

1R02TCR0072518

Identifier Type: -

Identifier Source: org_study_id