600 Participants Needed

SPARK Cognitive Status Indicator for Dementia

(REMIND-V Trial)

MG
Overseen ByMarinela Gombosev, President, COO
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Spark Neuro Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

KY

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
See 18 more

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
1Treatment groups
Experimental Treatment
Group I: Dementia subjectsExperimental Treatment1 Intervention
EEG data from subjects are used to validate algorithm

Find a Clinic Near You

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+
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