Software Validation Study-Cognitive Status Indicator

Last updated: July 15, 2025
Sponsor: Spark Neuro Inc.
Overall Status: Active - Enrolling

Phase

N/A

Condition

Dementia

Memory Loss

Mild Cognitive Impairment

Treatment

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

SPARK Cognitive Status Indicator

Clinical Study ID

NCT06809725
1002
2R44AG078039-02
  • Ages 65-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 theduration 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 informationabout 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 theduration 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 informationabout 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 authorizedrepresentative or individual

  2. Stated willingness to comply with all study procedures and availability for theduration 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 informationabout 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 morehours per month with subject. 3. Available and willing (remotely or in-person) toprovide information about subject cognitive functioning

Exclusion

  • 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 contactsin the opinion of the user

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: SPARK Cognitive Status Indicator (software support data collected via EEG)
Phase:
Study Start date:
March 31, 2025
Estimated Completion Date:
June 01, 2026

Study 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).

Connect with a study center

  • Remote

    Miami, Florida 33101
    United States

    Site Not Available

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