SPARK Cognitive Status Indicator for Dementia

(REMIND-V Trial)

Overseen By Marinela Gombosev, President, COO

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Spark Neuro Inc.

Disqualifiers: Skin disease on scalp

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a software tool called the SPARK Cognitive Status Indicator to evaluate its ability to detect various levels of cognitive function, such as normal thinking abilities, mild cognitive issues, or dementia. It uses a brain wave test (EEG) for assessments and compares these results to expert opinions. The trial includes participants aged 65 to 90 who either have no memory problems, have mild cognitive issues, or have dementia. Participants must have someone familiar with them to provide information about their cognitive abilities. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that may enhance early detection of cognitive issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the SPARK Cognitive Status Indicator is safe for assessing cognitive status?

Research has shown that the SPARK Cognitive Status Indicator is a software tool, not a traditional medical treatment. It analyzes brain wave data from EEGs (electroencephalograms) to assess cognitive health. As software, it lacks the risks associated with medications or surgeries. No reports of side effects exist because it only uses data from existing EEG tests, making it a low-risk option for participants. The software aims to diagnose dementia or cognitive issues more accurately by comparing its results with expert opinions. While it doesn't present "safety" concerns like other treatments, using the SPARK software remains non-invasive and safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SPARK Cognitive Status Indicator is unique because it uses EEG data to validate an algorithm that could offer a new way to assess cognitive status in dementia patients. Unlike standard treatments that typically focus on slowing down the progression of symptoms through medications like cholinesterase inhibitors and memantine, this approach aims to improve diagnostic accuracy. Researchers are excited about this because it could lead to earlier and more precise detection of dementia, potentially allowing for timely interventions and better patient outcomes.

What evidence suggests that the SPARK Cognitive Status Indicator is effective for assessing dementia?

Research has shown that the SPARK Cognitive Status Indicator uses a special program to assess brain activity through an EEG, a test that measures electrical signals in the brain. This aids in understanding a person's cognitive health. Studies have found that advanced computer techniques can diagnose cognitive issues like mild cognitive impairment (MCI) and dementia. The SPARK system aims to match or surpass the effectiveness of current expert methods. By analyzing brain activity patterns, it seeks to offer a quicker and potentially more accurate assessment of cognitive health. This could lead to earlier detection and better management of conditions like Alzheimer's disease. ^{2 3 6 7 8}

Who Is on the Research Team?

Keith Yoder, PI, PhD

Principal Investigator

SPARK Neuro

Are You a Good Fit for This Trial?

This trial is for men and women aged 65-90 who may have mild cognitive issues or dementia, with an SDTP score of at least 24. Participants must consent to the study's procedures and have an informant willing to provide information about their cognitive functioning.

Inclusion Criteria

Unimpaired subjects: Provision of signed and dated informed consent form

Unimpaired subjects: Stated willingness to comply with all study procedures and availability for the duration of the study

Unimpaired subjects: Have a Salzburg Dementia Test Prediction (SDTP) score >= 24

Exclusion Criteria

I have a skin condition on my scalp that might interfere with medical equipment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 days

1 visit (remote via telephone or video)

Evaluations

Participants undergo EEG scan, Clinical Dementia Rating, Mini-Mental State Exam, Functional Assessment Staging Tool, and blood assessments

2-3 days

1 visit (at home)

Follow-up

Participants are monitored for safety and effectiveness after evaluations

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SPARK Cognitive Status Indicator

Trial Overview The SPARK Cognitive Status Indicator software is being tested. It analyzes EEG recordings to determine if a person's cognitive status is unimpaired, has MCI, or dementia. The results will be compared with diagnoses from an expert panel.

How Is the Trial Designed?

Group I: Dementia subjects Experimental Treatment 1 Intervention

EEG data from subjects are used to validate algorithm

Who Is Running the Clinical Trial?

Spark Neuro Inc.

Lead Sponsor

Trials

4

Recruited

1,500+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. withpower.com withpower.com/trial/spark-cognitive-status-indicator-for-dementia-112f4

SPARK Cognitive Status Indicator for Dementia · Info ... This study will compare SPARK Cognitive Status Indicator output to Adjudication Committee panel-based diagnosis of cognitive status and Alzheimer's disease.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05406778

The REMIND Study- SPARK Neuro Software Study The aim of this study is to collect data to support development of an algorithm to determine whether applying machine-learning techniques to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10955778/

Artificial intelligence for dementia—Applied models and ... This narrative review synthesizes understanding of applied models and digital health technologies, in terms of dementia risk prediction, diagnostic ...

4. bmcprimcare.biomedcentral.com bmcprimcare.biomedcentral.com/articles/10.1186/s12875-025-02977-w

An innovative health systems approach to support early ... Observational study of patient characteristics associated with a timely diagnosis of dementia and mild cognitive impairment without dementia.

5. arxiv.org arxiv.org/html/2507.05463v2

Driving as a Diagnostic Tool: Scenario-based Cognitive ... The timely identification of MCI provides an opportunity to slow disease progression, improve quality of life, and reduce the societal burden ...

6. ctv.veeva.com ctv.veeva.com/study/software-validation-study-cognitive-status-indicator

Software Validation Study-Cognitive Status Indicator This study will compare SPARK Cognitive Status Indicator output to Adjudication Committee panel-based diagnosis of cognitive status and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3613863/

Assessment of cognition in early dementia - PubMed Central Better tools for assessing cognitive impairment in the early stages of Alzheimer's disease (AD) are required to enable diagnosis of the disease before ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/joim.20098

Implementing early detection of cognitive impairment in ... The importance of primary care in identifying cognitive impairment to mitigate ADRD risk, address reversible causes, and promote brain health.