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

600 Participants Needed

Trial Summary

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 is the purpose of this trial?

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.

Research Team

Keith Yoder, PI, PhD

Principal Investigator

SPARK Neuro

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+