Alzheimer DiseaseREMIND-VNCT06809725
Software Validation Study-Cognitive Status Indicator
A study testing SPARK Cognitive Status Indicator (software support data collected via EEG) in people with Alzheimer Disease and Mild Cognitive Impairment, run by Spark Neuro Inc. at 1 site in United States.
Trial summary
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+). Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- What is being tested?
- SPARK Cognitive Status Indicator (software support data collected via EEG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Unimpaired subjects:
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 65 to 90 at the time of consent
- Have a Salzburg Dementia Test Prediction (SDTP) score >= 24.
Show all 28Show fewer
- Informant, available and willing (remotely or in-person) to provide information about subject cognitive functioning
- No Medical History of cognitive impairment
- Mild Cognitive Impairment subjects:
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- 1. Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 65 to 90 at the time of consent
- Have a Salzburg Dementia Test Prediction (SDTP) score < 24.
- Informant, available and willing (remotely or in-person) to provide information about subject cognitive functioning
- Suspected or diagnosed with a mild cognitive issue
- Dementia subjects:
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form-legally authorized representative or individual
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 65 to 90 at the time of consent
- Have a Salzburg Dementia Test Prediction (SDTP) score < 24.
- Informant, available and willing (remotely or in-person) to provide information about subject cognitive functioning
- Exhibiting and diagnosed with moderate or severe cognitive issue
- Informants:
- To be eligible to participate as an informant in this study, an individual must meet all of the following criteria:
- 1. Provision of signed and dated informed consent form 2. Typically spends 2 or more hours per month with subject. 3. Available and willing (remotely or in-person) to provide information about subject cognitive functioning
- -
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 1. Currently experiencing a skin disease on scalp that would affect electrode contacts in the opinion of the user
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validation of the SPARK Scan Cognitive Status Indicator Software Concordance With Clinical Diagnosis in Humans With Unimpaired, Mild Cognitive Impairment and Dementia Status, With and Without Alzheimer's Disease
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.
Read the detailed description
Up to 600 subjects (and informants) may be enrolled and have a brain scan, cognitive, and blood assessments collected:
Visit 1-Screening:
-Salzburg (SDTP)- remote via telephone or video visit
Visit 2/3-Evaluations:
- EEG Scan (brain scan)
- Mini-Mental State Exam (MMSE)-at home visit
- Functional Assessment Staging Tool (FAST)- at home via video visit
- blood- Amyloid Beta 42/40 ratio, p tau- at laboratory or home visit There are three instances of subject engagement with the study team after informed consent. One, during screening which may be a remote visit and and two different home or remote visits (or laboratory visit). The study participation ends when all of the assessments have been collected. The total duration of subject participation should be no more than 2-3 days within a 90 day period.
The output of the investigational software used in the analysis to determine a identification of cognitive and Alzheimer's status based the data from the EEG scan shall be compared to the identification of cognitive and Alzheimer's status from a group of dementia specialists forming an Adjudication Committee which shall review all data (except for investigational device output).
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Being tested
- SPARK Cognitive Status Indicator (software support data collected via EEG)
- Keywords
- Alzheimer, dementia, Mild Cognitive Impairment, EEG
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Dementia subjects | Experimental | EEG data from subjects are used to validate algorithm Receives: Diagnostic Test: SPARK Cognitive Status Indicator (software support data collected via EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of SPARK Cognitive Status Indicator compared to Adjudicated cognitive status
Software output of investigational device shall be compared to the cognitive status as determined by an Adjudication Committee
Measured: Day 1
Sensitivity of SPARK Cognitive Status Indicator when identifying Alzheimer's disease in impaired subjects
Software output sensitivity will be computed from device AD+ output compared to the Adjudication Committee findings of AD positive cases (MCI and dementia subjects)
Measured: Day 1
Specificity of SPARK Cognitive Status Indicator when identifying Alzheimer's disease in impaired subjects
Software output specificity will be computed from device AD- output compared to the Adjudication Committee findings of AD negative cases (MCI and dementia subjects)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start31 Mar 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Software validation study (EEG used as data collection intervention)
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spark Neuro Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Keith Yoder, PI, PhD, Principal investigator, SPARK Neuro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809725
- Sponsor's protocol ID
- 1002
- Other IDs
- 2R44AG078039-02
- Acronym
- REMIND-V
- Status last verified
- Jul 2025
- First submitted
- 30 Jan 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the SPARK Scan Cognitive Status Indicator Software Concordance With Clinical Diagnosis in Humans With Unimpaired, Mild Cognitive Impairment and Dementia Status, With and Without Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06809725
- Acronym / sponsor ID
- REMIND-V / 1002
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Keywords
- Alzheimer, dementia, Mild Cognitive Impairment, EEG
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Spark Neuro Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Up to 600 subjects (and informants) may be enrolled and have a brain scan, cognitive, and blood assessments collected:
Visit 1-Screening:
-Salzburg (SDTP)- remote via telephone or video visit
Visit 2/3-Evaluations:
- EEG Scan (brain scan)
- Mini-Mental State Exam (MMSE)-at home visit
- Functional Assessment Staging Tool (FAST)- at home via video visit
- blood- Amyloid Beta 42/40 ratio, p tau- at laboratory or home visit There are three instances of subject engagement with the study team after informed consent. One, during screening which may be a remote visit and and two different home or remote visits (or laboratory visit). The study participation ends when all of the assessments have been collected. The total duration of subject participation should be no more than 2-3 days within a 90 day period.
The output of the investigational software used in the analysis to determine a identification of cognitive and Alzheimer's status based the data from the EEG scan shall be compared to the identification of cognitive and Alzheimer's status from a group of dementia specialists forming an Adjudication Committee which shall review all data (except for investigational device output).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Software validation study (EEG used as data collection intervention)
| Arm | Type | Receives |
|---|---|---|
| Dementia subjects | Experimental | Diagnostic Test: SPARK Cognitive Status Indicator (software support data collected via EEG)EEG data from subjects are used to validate algorithm |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (28 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 65 to 90 at the time of consent
- Have a Salzburg Dementia Test Prediction (SDTP) score >= 24.
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 1. Currently experiencing a skin disease on scalp that would affect electrode contacts in the opinion of the user
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPARK Cognitive Status Indicator (software support data collected via EEG)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. | Diagnostic test | Dementia subjects |
Primary outcome
Accuracy of SPARK Cognitive Status Indicator compared to Adjudicated cognitive status
Time frame: Day 1
Software output of investigational device shall be compared to the cognitive status as determined by an Adjudication Committee
Sensitivity of SPARK Cognitive Status Indicator when identifying Alzheimer's disease in impaired subjects
Time frame: Day 1
Software output sensitivity will be computed from device AD+ output compared to the Adjudication Committee findings of AD positive cases (MCI and dementia subjects)
Specificity of SPARK Cognitive Status Indicator when identifying Alzheimer's disease in impaired subjects
Time frame: Day 1
Software output specificity will be computed from device AD- output compared to the Adjudication Committee findings of AD negative cases (MCI and dementia subjects)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keith Yoder, PI, PhD principal investigator
SPARK Neuro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPARK Cognitive Status Indicator (software support data collected via EEG) in people with Alzheimer Disease and Mild Cognitive Impairment, run by Spark Neuro Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of SPARK Cognitive Status Indicator compared to Adjudicated cognitive status (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.