Software Validation Study-Cognitive Status Indicator

Summary

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.

Interventions

• SPARK Cognitive Status Indicator (software support data collected via EEG) · DIAGNOSTIC_TEST

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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 Cognitive Impairment subjects:

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. 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. 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:

1. Provision of signed and dated informed consent form-legally authorized representative or individual
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. 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:

1\. Provision of signed and dated informed consent form 2. Typically spends 2 or more hours per month with subject. 3. Available and willing (remotely or in-person) to provide information about subject cognitive functioning

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Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1\. Currently experiencing a skin disease on scalp that would affect electrode contacts in the opinion of the user

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Sites (1)

• Remote, Miami, Florida