Software Validation Study-Cognitive Status Indicator

NCT ID: NCT06809725

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-06-01

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 2/3-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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Dementia subjects

EEG data from subjects are used to validate algorithm

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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, 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, 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, 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 2 or more hours per month with subject. 3. Available and willing (remotely or in-person) to provide information about subject cognitive functioning

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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

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• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Spark Neuro Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith Yoder, PI, PhD

Role: PRINCIPAL_INVESTIGATOR

SPARK Neuro

Locations

Remote

Miami, Florida, United States

Countries

United States

Other Identifiers

2R44AG078039-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1002

Identifier Type: -

Identifier Source: org_study_id