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NCT06809725

Software Validation Study-Cognitive Status Indicator

Enrolling by Invitation
NAAges 65–90InterventionalDiagnostic
Spark Neuro Inc.
~600 participants
Updated 2025-07-18 on ClinicalTrials.gov
What's tested:SPARK Cognitive Status Indicator (software support data collected via EEG)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of SPARK Cognitive Status Indicator compared to Adjudicated cognitive status
Measured over Day 1
+2 more outcomes measured

Conditions

Alzheimer Disease
Mild Cognitive Impairment
Dementia

Explore related trials

Alzheimer's DiseaseDementiaMild cognitive disorder

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Keith Yoder, PI, PhD · PRINCIPAL_INVESTIGATOR · SPARK Neuro

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Accuracy of SPARK Cognitive Status Indicator compared to Adjudicated cognitive statusDay 1

    Software output of investigational device shall be compared to the cognitive status as determined by an Adjudication Committee

  • Sensitivity of SPARK Cognitive Status Indicator when identifying Alzheimer's disease in impaired subjectsDay 1

    Software output sensitivity will be computed from device AD+ output compared to the Adjudication Committee findings of AD positive cases (MCI and dementia subjects)

  • Specificity of SPARK Cognitive Status Indicator when identifying Alzheimer's disease in impaired subjectsDay 1

    Software output specificity will be computed from device AD- output compared to the Adjudication Committee findings of AD negative cases (MCI and dementia subjects)