Software Validation Study-Cognitive Status Indicator

Part of paid clinical trials in Miami, Florida.

Sponsor
Spark Neuro Inc.
Study ID
NCT06809725
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
Jul 2025
Primary completion
Apr 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
600 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Dementia subjects
    EEG data from subjects are used to validate algorithm

Primary Outcome Measure

Accuracy of SPARK Cognitive Status Indicator compared to Adjudicated cognitive status [ Time Frame: Day 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
RemoteMiamiFlorida33101-

Find similar trials in Miami, FL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Remote· Miami, FL

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