SPARK Neuro REMIND Study

Not Applicable

Recruiting

• Conditions: Alzheimer Disease; Cognitive Impairment
• Interventions: Device: SPARK Test

• Registration Number: NCT05406778
• Lead Sponsor: Spark Neuro Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-05-18
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-08
• Primary Completion: 2025-05
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TBD	SPARK Test	-

Primary Outcome Measures

Name	Time	Method
Software malfunction occurrences	10 weeks	Report rate of software malfunction occurrences that resulted in a failure to complete a SPARK Test recording.
Assessment of patients SPARK Test data	10 weeks	* 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)

Secondary Outcome Measures

Name	Time	Method
Mean absolute error for specific cognitive assessment	10 weeks	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)

Trial Locations

Locations (1)

Voyage Medical; 🇺🇸 Tempe, Arizona, United States