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ENROLLING BY INVITATION

NCT06809725

Software Validation Study-Cognitive Status Indicator

Sponsor: Spark Neuro Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

65 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2025-03-31

Completion Date

2026-06-01

Last Updated

2025-07-18

Healthy Volunteers

Yes

Conditions

Alzheimer Disease Mild Cognitive Impairment Dementia

Interventions

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.

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 \- 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 \-

Locations (1)

Remote

Miami, Florida, United States