Software Validation Study-Cognitive Status Indicator
Enrolling by invitation · Not applicable
Conditions studied: Alzheimer Disease, Mild Cognitive Impairment, Dementia
In brief
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.
Key facts
- Study ID
- NCT06809725
- Run by
- Spark Neuro Inc.
- People needed
- 600
- Starts
- 2025-03-31
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-07-18
Who can join
Age: 65 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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 >= 24.
- 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:
- 1. 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 < 24.
- 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 < 24.
- 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:
You may not qualify if…
- 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
Where it is running
- Remote — Miami, Florida, United States
Full record on ClinicalTrials.gov
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