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About
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.
Full description
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-Evaluations:
The output of the investigational software used in the analysis to determine a identification of cognitive and Alzheimer's status based the data from the EEG scan shall be compared to the identification of cognitive and Alzheimer's status from a group of dementia specialists forming an Adjudication Committee which shall review all data (except for investigational device output).
Enrollment
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Inclusion criteria
Unimpaired subjects:
To be eligible to participate in this study, an individual must meet all of the following criteria:
Mild Cognitive Impairment subjects:
To be eligible to participate in this study, an individual must meet all of the following criteria:
Dementia subjects:
To be eligible to participate in this study, an individual must meet all of the following criteria:
Informants:
To be eligible to participate as an informant in this study, an individual must meet all of the following criteria:
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
Primary purpose
Allocation
Interventional model
Masking
600 participants in 1 patient group
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Central trial contact
Marinela Gombosev, President, COO
Data sourced from clinicaltrials.gov
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