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Evidence Amyloid Scan EEG Study (EASES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03644043
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Institute of Asian American Adult Development
Information provided by (Responsible Party):
Metabolic Therapy Inc.

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.

Condition or disease Intervention/treatment
Alzheimer Disease Dementia Frontal Mild Cognitive Impairment Device: EEG scan

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Quantitative EEG for Assessment of Mild Cognitive Impairment Associated With Preclinical Alzheimer's Disease - Evidence for Amyloid Indication Study
Actual Study Start Date : July 20, 2018
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : November 30, 2020


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants must be referred by qualified dementia specialists for EEG brain scan.
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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644043


Contacts
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Contact: Dewey Brown II, PhD 2145174004 kruss3@gmail.com
Contact: Kenneth O Russell 5129097963 kruss3@gmail.com

Locations
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United States, Texas
Translational Cognitive Research Recruiting
Houston, Texas, United States, 77036
Contact: Dewey Brown II, PhD         
Sponsors and Collaborators
Metabolic Therapy Inc.
Institute of Asian American Adult Development
Additional Information:

Publications:
Michel CM. Electrical Neuroimaging. Cambridge University Press, Cambridge 2009.
1. Cassani R, Falk TH, Fraga FJ, Cecchi M, Moore DK, Anghinah R. Towards automated electroencephalography-based Alzheimer's disease diagnosis using portable low-density devices. Biomedical Signal Processing and Control. 2017,33:261-71.

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Responsible Party: Metabolic Therapy Inc.
ClinicalTrials.gov Identifier: NCT03644043    
Other Study ID Numbers: 1R02TCR0072518
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

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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
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders