The REMIND Study- SPARK Neuro Software Study

SPARK Neuro Quantitative Resting State EEG Protocol for Assessing Cognitive Impairment and Alzheimer's Disease Status- The REMIND Study

The study utilizes investigational software, the SPARK Test, with an FDA-cleared electroencephalography (EEG) amplifier and EEG cap to collect and patient EEG data.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Alzheimer Disease
• Intervention / Treatment: Device: SPARK Test

Detailed Description

The aim of this study is to collect data to support development of an algorithm to determine whether applying machine-learning techniques to eyes open/eyes closed resting-state electroencephalography (EEG) can characterize patient's cognitive status and detect the presence or absence of AD on the basis of the patient's EEG.

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92318
      • Island Psych
  • Colorado
    • Englewood, Colorado, United States, 80110
      • CenExel Rocky Mountain
  • Florida
    • Ocala, Florida, United States, 34470
      • Renstar Medical
  • Michigan
    • Troy, Michigan, United States, 48083
      • Arcturus Healthcare PLC, Troy - Internal Medicine Division
  • Nebraska
    • Lincoln, Nebraska, United States, 68501
      • Alivation Health
  • Texas
    • El Paso, Texas, United States, 79835
      • Advanced Neuro
  • Virginia
    • Falls Church, Virginia, United States, 22040
      • Integrated Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 55 to 85 at the time of consent
2. Informant available and willing (remotely or in-person) to provide information about sleep patterns and cognitive functioning who spends >8 hours per week with primary subject
3. Subject or Legally Authorized Representative (LAR) has the ability to provide informed consent and comply with the protocol.

Exclusion Criteria:

1. Unable to remain still for up to 30 minutes during EEG data recording
2. Subjects currently on and unable to wash out concomitant medications, including: 1) opiates; 2) benzodiazepines and nonbenzodiazepine hypnotics; 3) sedative antihistamines; 4) tricyclic anti-depressants; 5) skeletal muscle relaxants; 6) antiepileptics; 7) antipsychotics; 8) antimanic agents; 9) THC; 10) anticholinergics
3. Previous history of craniotomy
4. Medical or psychiatric illness that would interfere with study participation
5. History of epilepsy or chronic seizure disorder
6. Presence of non-dental metal in head
7. Currently experiencing a skin disease on scalp that would affect electrode contacts

8. Subject meets at least one of the following criteria:

   1. Diagnosis of cognitive impairment from various underlying pathologies as indicated by one of the diagnostic codes listed in Appendix A (protocol)
   2. MMSE score of 27 or less
   3. Treating physician or PI have documented that the patient is cognitively impaired, with judgment of cognitive impairment having been made within the 6 months prior to enrollment
9. Substance Use Disorder, including Alcohol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Subjects - Variable Cognitive Status; Subjects meeting Inclusion/Exclusion criteria with open eyes/closed eyes EEG collection.	Device: SPARK Test; Thirty (30) minutes of resting state EEG data collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG Data collection for AI software development	Rate of complete software collection per enrolled subjects complete a SPARK Test recording.	During the diagnostic procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean absolute error for specific cognitive assessment	Mean absolute error for Alzheimer's disease Assessment Scale - 14-item cognitive sbuscale (ADAS-Cog-14), Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL), iADRS, CDR and (Mini-Mental State Exam (MMSE)	10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alzheimer's Disease positive vs. negative indication for biomarker-confirmed AD	Rate of concordance between SPARK Test predicted Alzheimer's Disease positive/negative for biomarker-confirmed AD as measured by CSF-based markers including amyloid-Beta, Tau, phosphorylated-Tau, proteins related to amyloid processing or PET-based imaging.	10 weeks

Collaborators and Investigators

• Sponsor: Spark Neuro Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): August 24, 2023
• Study Completion (Actual): January 19, 2024

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: EEG; Electroencephalography; Machine learning
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease
• Other Study ID Numbers: 1001 (Registro Nacional Estudios Clinicos (RNEC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes