Spark Neuro Inc.
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.
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…
Inclusion Criteria: Unimpaired subjects: To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 65 to 90 at the time of consent 4. Have a Salzburg Dementia Test Prediction (SDTP) score \>= 24. 5. Informant, available and willing (remotely or in-person) to provide information about subject cognitive functioning 6. No Medical History of cognitive impairment Mild Cogn…
The SPARK Cognitive Status Indicator software (collected via EEG) is being validated to aid in the diagnosis of Alzheimer's disease in persons aged 65-90 with suspected cognitive impairment. The device, once validated, shall provide a clinician with a "positive" or "negative" output to indicate whether the subject's electroencephalogram (EEG) is consistent with EEGs of subjects diagnosed with Alzheimer's disease.
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