Software Validation Study-Cognitive Status Indicator

NCT06809725 | Enrolling By Invitation FDA Device

• 2 other identifiers: 10022R44AG078039-02
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Dementia

Keywords

Alzheimer; dementia; Mild Cognitive Impairment; EEG

Outcome Measures

Primary Outcomes (3)

• Accuracy of SPARK Cognitive Status Indicator compared to Adjudicated cognitive status

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

  Day 1

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

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

  Day 1

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

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

  Day 1

Study Arms (1)

Dementia subjects

EXPERIMENTAL

EEG data from subjects are used to validate algorithm

Diagnostic Test: SPARK Cognitive Status Indicator (software support data collected via EEG)

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.

Dementia subjects

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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:
• \. 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

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

Sponsors & Collaborators

• Spark Neuro Inc.: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Remote

Miami, Florida, 33101, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Keith Yoder, PI, PhD

  SPARK Neuro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Software validation study (EEG used as data collection intervention)

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: March 31, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

US (1)