The Clinical Utility of ERPs in the Diagnosis of Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Electroencephalogram (EEG) memory diagnosis
研究概览
简要总结
In this study, the investigators will use a novel electroencephalogram (EEG) system that participants will wear during a single in-person research session to investigate whether ERPs are now ready for validation as a tool clinicians can easily implement to increase diagnostic accuracy and confidence. This EEG will not be used to treat, cure, mitigate or diagnosis any disease and there will be no safety or efficacy data collected about the machine for any purpose including support of FDA submission.
The investigators will compare the ERP data to that of neuropsychological testing in order to determine the degree of correlation between these two measures. Questionnaires on cognition, mood, and fluency will be administered prior to the EEG to establish a baseline. ERP data from the EEG session will be compared with the results of the neuropsychological battery in order to determine whether the implementation of ERPs in the existing workflow of clinicians can aid in diagnostic accuracy, thus altering clinical management.
详细描述
A cross sectional cohort study design with four groups will be implemented to determine how ERPs can provide diagnostic information and alter clinical management beyond that of neuropsychological testing alone in patients with Alzheimer's disease (AD) or Mild Cognitive Impairment (MCI).
Secondary Objectives:
- To determine the impact of ERP testing (using cognitive health assessment reports) on change in research grade clinical diagnosis
- To determine the degree of correlation between quantitative ERP measures with neuropsychological testing performance using a standardized neuropsychological battery.
75 mild AD dementia and 75 MCI due to any etiology, 25 Older Adults (OA) and 25 Younger Adults (YA) will be enrolled over the course of two years. Each subject will participate in the study for 1 visit.
The in person 50-60-minute testing session consists of a neuropsychological battery, and an EEG session with computer tasks including the Auditory Oddball paradigm, a Continuous Visual Memory Test, Auditory Evoked Potentials, Visual Evoked Potentials, the Erikson Flanker Task, and the Hayling Task.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Mild Alzheimer Disease (AD) dementia
- •Meets probable AD dementia National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
- •50-90 years old
- •Mini-Mental State Examination (MMSE) 20-27
- •Performance on delayed recall and recognition memory worse than 1.5 standard deviation (SD) for age and education
- •Performance on delayed recall and recognition memory worse than 1.5 SD for age & education in at least one other cognitive domain (e.g., language, executive functioning) based on other tests in our neuropsychological test battery.
- •Dr. Turk and Dr. Budson will confirm all mild AD dementia diagnoses
- •For Mild cognitive impairment (MCI)
- •MCI due to any etiology 50-90 years old
- •MMSE > 23
- •Performance on delayed recall and recognition memory worse than 1.0 SD for age & education adjusted norms
- •Dr. Turk and Dr. Budson will confirm all MCI diagnoses
- •For Healthy older adults
- •50-90 years old
- •Functioning normally in occupation determined by self-report
- •For Healthy younger adults
- •20-50 years old
- •Functioning normally in occupation determined by self-report
排除标准
- •A clinically significant problem of any of the following conditions:
- •depression
- •heavy alcohol or drug use
- •cerebrovascular disease
- •a different degenerative disease (e.g., fronto-temporal dementia, Parkinson's disease)
- •any medical condition whose severity could significantly impair cognition (e.g., organ failure)
- •on any antipsychotic or epilepsy medication
- •Unable to understand the consent form
结局指标
主要结局
Electroencephalogram (EEG) memory diagnosis
时间窗: baseline
The EEG memory diagnosis will be arrived through the blinded review of the EEG data
次要结局
- Boston Naming Test(baseline)
- Consortium to Establish a Registry in Alzheimer's disease Word List Test (CERAD)(baseline)
- EEG amplitude(baseline)
- The Montreal Cognitive Assessment (MoCA) performance(baseline)
- Verbal Fluency test: Phonemic Test and the Category Fluency test(baseline)
- Mini Mental State Examination (MMSE)(baseline)
- EEG latency(baseline)
- Trails Making Test A and B(baseline)