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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44AG078039-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dementia subjects | Experimental | EEG data from subjects are used to validate algorithm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARK Cognitive Status Indicator (software support data collected via EEG) | 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. |
| 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 |
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Inclusion Criteria:
Unimpaired subjects:
To be eligible to participate in this study, an individual must meet all of the following criteria:
Mild Cognitive Impairment subjects:
To be eligible to participate in this study, an individual must meet all of the following criteria:
Dementia subjects:
To be eligible to participate in this study, an individual must meet all of the following criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Keith Yoder, PI, PhD | SPARK Neuro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Remote | Miami | Florida | 33101 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 6, 2026 | Feb 24, 2026 | 5 | ||
| Mar 10, 2026 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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Software validation study (EEG used as data collection intervention)
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|
| Mar 27, 2026 |
| 6 |
| Apr 24, 2026 | May 15, 2026 | 7 |
| May 29, 2026 | Jun 25, 2026 | 8 |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |