Evidence Amyloid Scan EEG Study (EASES)

August 22, 2018 updated by: Metabolic Therapy Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77036
        • Recruiting
        • Translational Cognitive Research
        • Contact:
          • Dewey Brown II, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants must be referred by qualified dementia specialists for EEG brain scan.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Early stage of MCI symptoms
Subjects with cognitive decline representing MCI symptomology and with previous PET amyloid-beta (Aβ) imaging results.
Device: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 10 days
Test whether qEEG P300 and P50 waveform amplitudes and auditory response times will lead to correlation with amyloid deposition
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Metabolic Therapy Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institute of Asian American Adult Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R02TCR0072518

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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