Software Validation Study-Cognitive Status Indicator (REMIND-V)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Dementia; Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: Diagnostic test: SPARK Cognitive Status Indicator (software support data collected via EEG)

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).

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33101
      • Remote

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dementia subjects; EEG data from subjects are used to validate algorithm

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Spark Neuro Inc.
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Keith Yoder, PI, PhD, SPARK Neuro

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: dementia; Mild Cognitive Impairment; Alzheimer; EEG
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease; Dementia
• Other Study ID Numbers: 1002; 2R44AG078039-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No