Recruiting

Amyloid Scan

Sponsor:

Metabolic Therapy Inc.

Code:

NCT03644043

Conditions

Alzheimer Disease

Dementia Frontal

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

EEG scan

Study Details

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.

Conditions

Alzheimer Disease

Dementia Frontal

Mild Cognitive Impairment

Study ID

NCT03644043

Start date

Jul 20, 2018

Status verified date

Aug, 2018

Completion date

Nov 30, 2020

Anticipated

Primary completion date

Nov 15, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Early stage of MCI symptoms

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

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Dewey Brown II, PhD

2145174004kruss3@gmail.com

Kenneth O Russell

5129097963kruss3@gmail.com

Locations

Translational Cognitive Research

Recruiting

Houston, Texas, United States, 77036

More Information

Sponsor

Metabolic Therapy Inc.

Last update posted

Aug 23, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Metabolic Therapy Inc. on 2018-08-23.