NCT06809725

Software Validation Study-Cognitive Status Indicator

Validation of the SPARK Scan Cognitive Status Indicator Software Concordance With Clinical Diagnosis in Humans With Unimpaired, Mild Cognitive Impairment and Dementia Status, With and Without Alzheimer's Disease

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Spark Neuro Inc. · Industry
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 remote visits (or laboratory visit). The study participation ends when all of the assessments have been collected. The total duration of subject participation should be no more than 2-3 days within a 90 day period. The output of the investigational software used in the analysis to determine a identification of cognitive and Alzheimer's status based the data from the EEG scan shall be compared to the identification of cognitive and Alzheimer's status from a group of dementia specialists forming an Adjudication Committee which shall review all data (except for investigational device output).

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Dementia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SPARK Cognitive Status Indicator (software support data collected via EEG)	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.

Timeline

• Start date: 2025-03-31
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2025-02-05
• Last updated: 2025-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study