Alzheimer DiseaseNCT05406778
The REMIND Study- SPARK Neuro Software Study
A study testing SPARK Test in people with Alzheimer Disease and Cognitive Impairment, run by Spark Neuro Inc. at 7 sites in United States.
Trial summary
The study utilizes investigational software, the SPARK Test, with an FDA-cleared electroencephalography (EEG) amplifier and EEG cap to collect and patient EEG data. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Cognitive Impairment
- What is being tested?
- SPARK Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 May 2022to 19 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 craniotomy
- Medical or psychiatric illness that would interfere with study participation
- History of epilepsy or chronic seizure disorder
- Presence of non-dental metal in head
Show all 12Show fewer
- Currently experiencing a skin disease on scalp that would affect electrode contacts
- Subject meets at least one of the following criteria:
- Diagnosis of cognitive impairment from various underlying pathologies as indicated by one of the diagnostic codes listed in Appendix A (protocol)
- MMSE score of 27 or less
- 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
- Substance Use Disorder, including Alcohol
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Advanced Neuro
El Paso, Texas, 79835
CenExel Rocky Mountain
Englewood, Colorado, 80110
Integrated Neurology
Falls Church, Virginia, 22040
Alivation Health
Lincoln, Nebraska, 68501
Island Psych
Loma Linda, California, 92318
Renstar Medical
Ocala, Florida, 34470
Arcturus Healthcare PLC, Troy - Internal Medicine Division
Troy, Michigan, 48083
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Being tested
- SPARK Test
- Keywords
- EEG, Electroencephalography, Machine learning
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARK TestDevice
Thirty (30) minutes of resting state EEG data collection.
| Study group | Role | What they receive |
|---|---|---|
| Subjects - Variable Cognitive Status | Other | Subjects meeting Inclusion/Exclusion criteria with open eyes/closed eyes EEG collection. Receives: Device: SPARK Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Data collection for AI software development
Rate of complete software collection per enrolled subjects complete a SPARK Test recording.
Measured: During the diagnostic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start18 May 2022
- Primary completion24 Aug 2023
- Study completion19 Jan 2024
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spark Neuro Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406778
- Sponsor's protocol ID
- 1001
- Status last verified
- Jul 2025
- First submitted
- 26 May 2022
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPARK Neuro Quantitative Resting State EEG Protocol for Assessing Cognitive Impairment and Alzheimer's Disease Status- The REMIND Study
- ClinicalTrials.gov ID
- NCT05406778
- Acronym / sponsor ID
- 1001
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Keywords
- EEG, Electroencephalography, Machine learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Spark Neuro Inc.Industry (pharma, biotech, devices)
- Study start
- 18 May 2022 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 6 Jun 2022 (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 study utilizes investigational software, the SPARK Test, with an FDA-cleared electroencephalography (EEG) amplifier and EEG cap to collect and patient EEG data.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects - Variable Cognitive Status | Other | Device: SPARK TestSubjects meeting Inclusion/Exclusion criteria with open eyes/closed eyes EEG collection. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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 craniotomy
- Medical or psychiatric illness that would interfere with study participation
- History of epilepsy or chronic seizure disorder
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 TestThirty (30) minutes of resting state EEG data collection. | Device | Subjects - Variable Cognitive Status |
Primary outcome
EEG Data collection for AI software development
Time frame: During the diagnostic procedure
Rate of complete software collection per enrolled subjects complete a SPARK Test recording.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPARK Test in people with Alzheimer Disease and Cognitive Impairment, run by Spark Neuro Inc. at 7 sites 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EEG Data collection for AI software development (time frame: During the diagnostic procedure). 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 14 Aug 2025.