Software Validation Study-Cognitive Status Indicator

Not Applicable

• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia

• Registration Number: NCT06809725
• Lead Sponsor: Spark Neuro Inc.

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.

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-Evaluations:

* EEG Scan (brain scan)

* Clinical Dementia Rating (CDR)- at home visit

* Mini-Mental State Exam (MMSE)-at home visit

* Functional Assessment Staging Tool (FAST)- at home visit

* blood- Amyloid Beta 42/40 ratio, p tau and APO-E proteotype There are two instances of subject engagement with the study team after informed consent. One, during screening which may be a remote visit and and Two, during a home 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 30 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).

Study Timeline

• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-02-04
• Study First Posted: 2025-02-05
• Study Start: 2025-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-04-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 600

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 the duration 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, who typically spends 8 or more hours per week with subject, available and willing (remotely or in-person) to provide information about 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 the duration 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, who typically spends 8 or more hours per week with subject, available and willing (remotely or in-person) to provide information about 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 authorized representative or individual
2. Stated willingness to comply with all study procedures and availability for the duration 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, who typically spends 8 or more hours per week with subject, available and willing (remotely or in-person) to provide information about 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 8 or more hours per week with subject. 3. Available and willing (remotely or in-person) to provide information about subject cognitive functioning

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 contacts in the opinion of the user

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Accuracy of SPARK Cognitive Status Indicator compared to Adjudicated cognitive status	Day 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 subjects	Day 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 subjects	Day 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)

Trial Locations

Locations (1)

Remote; 🇺🇸 Miami, Florida, United States