SPARK Neuro REMIND Study

Alzheimer Disease Clinical Trial

Official title:

SPARK Neuro Quantitative Resting State EEG Protocol for Assessing Cognitive Impairment and AD Status 'REMIND' Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05406778
• Other study ID #: 1001
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: November 2025

Study information

• Verified date: July 2022
• Source: Spark Neuro Inc.
• Contact: Marinela Gombosev
• Phone: 929-515-6003
• Email: study1001[@]sparkneuro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The aim of this study is to develop an algorithm and then evaluate it to determine whether applying machine-learning techniques to 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: November 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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 stroke, severe head injury, craniotomy or any other potentially confounding neurologic illness causing known structural brain damage

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. TICS score indicative of cognitive impairment at screening

9. Substance Use Disorder, including Alcohol

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Device:
• SPARK Test
Twenty (20) minutes of resting state EEG data collection.

Locations

Country	Name	City	State
United States	Voyage Medical	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Spark Neuro Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Software malfunction occurrences	Report rate of software malfunction occurrences that resulted in a failure to complete a SPARK Test recording.	10 weeks
Primary	Assessment of patients SPARK Test data	Rate of concordance between SPARK Test score of Alzheimer's Disease (AD) label (positive or negative) with clinical diagnosis; Rate of concordance between SPARK Test Cognitive Impairment Index (CII) score predictive of Montreal Cognitive Assessment (MoCA score); Rate of concordance between SPARK Test cognitive status label (unimpaired, Mild Cognitive Impairment (MCI), mild dementia, moderate dementia, severe dementia with unimpaired/MCI/dementia labels operationalized by Clinical Dementia Rating (CDR)	10 weeks
Secondary	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