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临床试验/NCT03644043
NCT03644043Unknown不适用

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

Metabolic Therapy Inc.1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年7月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 consideration

排除标准

  • 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.

结局指标

主要结局

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.

时间窗: 10 days

Test whether qEEG P300 and P50 waveform amplitudes and auditory response times will lead to correlation with amyloid deposition

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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