Validation of the SPARK Scan Cognitive Status Indicator Software Concordance With Clinical Diagnosis in Humans With Unimpaired, Mild Cognitive Impairment and Dementia Status, With and Without Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Accuracy of SPARK Cognitive Status Indicator compared to Adjudicated cognitive status
研究概览
简要总结
The SPARK Cognitive Status Indicator software uses an algorithm to assess a resting state EEG recording as being consistent with a cognitive status of unimpaired, mild cognitive impairment (MCI; MCI AD- or MCI AD+), or dementia (dementia AD-, or dementia AD+). This study will compare SPARK Cognitive Status Indicator output to Adjudication Committee panel-based diagnosis of cognitive status and Alzheimer's disease.
详细描述
Up to 600 subjects (and informants) may be enrolled and have a brain scan, cognitive, and blood assessments collected:
Visit 1-Screening:
-Salzburg (SDTP)- remote via telephone or video visit
Visit 2/3-Evaluations:
- EEG Scan (brain scan)
- Mini-Mental State Exam (MMSE)-at home visit
- Functional Assessment Staging Tool (FAST)- at home via video visit
- blood- Amyloid Beta 42/40 ratio, p tau- at laboratory or home visit There are three instances of subject engagement with the study team after informed consent. One, during screening which may be a remote visit and and two different home or remote visits (or laboratory visit). The study participation ends when all of the assessments have been collected. The total duration of subject participation should be no more than 2-3 days within a 90 day period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unimpaired subjects:
- •To be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 65 to 90 at the time of consent
- •Have a Salzburg Dementia Test Prediction (SDTP) score >=
- •Informant, available and willing (remotely or in-person) to provide information about subject cognitive functioning
- •No Medical History of cognitive impairment
- •Mild Cognitive Impairment subjects:
- •To be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 65 to 90 at the time of consent
- •Have a Salzburg Dementia Test Prediction (SDTP) score <
- •Informant, available and willing (remotely or in-person) to provide information about subject cognitive functioning
- •Suspected or diagnosed with a mild cognitive issue
- •Dementia subjects:
- •To be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form-legally authorized representative or individual
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 65 to 90 at the time of consent
- •Have a Salzburg Dementia Test Prediction (SDTP) score <
- •Informant, available and willing (remotely or in-person) to provide information about subject cognitive functioning
- •Exhibiting and diagnosed with moderate or severe cognitive issue
- •Informants:
- •To be eligible to participate as an informant in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form
- •Typically spends 2 or more hours per month with subject.
- •Available and willing (remotely or in-person) to provide information about subject cognitive functioning
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Currently experiencing a skin disease on scalp that would affect electrode contacts in the opinion of the user
研究组 & 干预措施
Dementia subjects
EEG data from subjects are used to validate algorithm
干预措施: SPARK Cognitive Status Indicator (software support data collected via EEG) (Diagnostic Test)
结局指标
主要结局
Accuracy of SPARK Cognitive Status Indicator compared to Adjudicated cognitive status
时间窗: Day 1
Software output of investigational device shall be compared to the cognitive status as determined by an Adjudication Committee
Sensitivity of SPARK Cognitive Status Indicator when identifying Alzheimer's disease in impaired subjects
时间窗: Day 1
Software output sensitivity will be computed from device AD+ output compared to the Adjudication Committee findings of AD positive cases (MCI and dementia subjects)
Specificity of SPARK Cognitive Status Indicator when identifying Alzheimer's disease in impaired subjects
时间窗: Day 1
Software output specificity will be computed from device AD- output compared to the Adjudication Committee findings of AD negative cases (MCI and dementia subjects)
次要结局
未报告次要终点