Clinical trial NCT06809725: Software Validation Study-Cognitive Status Indicator
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Dementia
Keywords: Alzheimer
dementia
Mild Cognitive Impairment
EEG
Lead sponsor: Spark Neuro Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-02-05
Enrollment: 600
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Software validation study (EEG used as data collection intervention)
Primary purpose: DIAGNOSTIC

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).

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, 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

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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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Primary outcomes:
measure: Accuracy of SPARK Cognitive Status Indicator compared to Adjudicated cognitive status
timeFrame: Day 1
measure: Sensitivity of SPARK Cognitive Status Indicator when identifying Alzheimer's disease in impaired subjects
timeFrame: Day 1
measure: Specificity of SPARK Cognitive Status Indicator when identifying Alzheimer's disease in impaired subjects
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Remote
state: Florida
Study officials:
affiliation: SPARK Neuro
name: Keith Yoder, PI, PhD
role: PRINCIPAL_INVESTIGATOR
References: