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SPARK Neuro REMIND Study

Primary Purpose

Alzheimer Disease, Cognitive Impairment

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SPARK Test

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring EEG, Electroencephalography, Machine learning

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 55 to 85 at the time of consent
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
Subject or Legally Authorized Representative (LAR) has the ability to provide informed consent and comply with the protocol.

Exclusion Criteria:

Unable to remain still for up to 30 minutes during EEG data recording
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
Previous history of stroke, severe head injury, craniotomy or any other potentially confounding neurologic illness causing known structural brain damage
Medical or psychiatric illness that would interfere with study participation
History of epilepsy or chronic seizure disorder
Presence of non-dental metal in head
Currently experiencing a skin disease on scalp that would affect electrode contacts
TICS score indicative of cognitive impairment at screening
Substance Use Disorder, including Alcohol

Sites / Locations

Voyage MedicalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TBD

Arm Description

Outcomes

Primary Outcome Measures

Software malfunction occurrences

Report rate of software malfunction occurrences that resulted in a failure to complete a SPARK Test recording.

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)

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT05406778

First Posted

May 26, 2022

Last Updated

July 6, 2022

Sponsor

Spark Neuro Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05406778

Brief Title

SPARK Neuro REMIND Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 18, 2022 (Actual)

Primary Completion Date

May 2025 (Anticipated)

Study Completion Date

November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Spark Neuro Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Cognitive Impairment

Keywords

EEG, Electroencephalography, Machine learning

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TBD

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

SPARK Test

Intervention Description

Twenty (20) minutes of resting state EEG data collection.

Primary Outcome Measure Information:

Title

Software malfunction occurrences

Description

Report rate of software malfunction occurrences that resulted in a failure to complete a SPARK Test recording.

Time Frame

10 weeks

Title

Assessment of patients SPARK Test data

Description

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Mean absolute error for specific cognitive assessment

Description

Time Frame

10 weeks

Other Pre-specified Outcome Measures:

Title

Alzheimer's Disease positive vs. negative indication for biomarker-confirmed AD

Description

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.

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 55 to 85 at the time of consent 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 Subject or Legally Authorized Representative (LAR) has the ability to provide informed consent and comply with the protocol. Exclusion Criteria: Unable to remain still for up to 30 minutes during EEG data recording 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 Previous history of stroke, severe head injury, craniotomy or any other potentially confounding neurologic illness causing known structural brain damage Medical or psychiatric illness that would interfere with study participation History of epilepsy or chronic seizure disorder Presence of non-dental metal in head Currently experiencing a skin disease on scalp that would affect electrode contacts TICS score indicative of cognitive impairment at screening Substance Use Disorder, including Alcohol

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marinela Gombosev

Phone

929-515-6003

study1001@sparkneuro.com

First Name & Middle Initial & Last Name or Official Title & Degree

Che Lucero

Phone

929-515-6003

study1001@sparkneuro.com

Facility Information:

Facility Name

Voyage Medical

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Crystal Brown

First Name & Middle Initial & Last Name & Degree

Ali Imran, MD

12. IPD Sharing Statement

Plan to Share IPD

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SPARK Neuro REMIND Study

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