Software Validation Study-Cognitive Status Indicator

Launched by SPARK NEURO INC. · Feb 4, 2025

Keywords

ClinConnect Summary

The SPARK Cognitive Status Indicator study is testing new software designed to help assess cognitive health, particularly for conditions like Alzheimer’s disease, mild cognitive impairment, and dementia. This software analyzes EEG recordings, which are tests that measure brain activity, to determine if someone has normal cognitive function, mild issues, or more serious dementia. The goal is to compare the software's results with evaluations made by a panel of experts to see how well it works.

To be part of this study, participants must be aged 65 to 90 and meet specific criteria based on their cognitive status. For example, those who are unimpaired should have a certain test score indicating good cognitive health, while those with mild cognitive impairment or dementia will have lower scores and a diagnosis of their condition. Participants will need to have someone close to them, like a family member or caregiver, who can provide information about their cognitive functioning. This is an exciting opportunity to contribute to research that could improve how we diagnose and understand cognitive health.

Gender

ALL

Eligibility criteria

• 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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