SPARK Test for Cognitive Impairment

No longer recruiting at 7 trial locations

Overseen By Che Lucero

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spark Neuro Inc.

Must not be taking: Opiates, Benzodiazepines, Antipsychotics, others

Disqualifiers: Stroke, Epilepsy, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new software called the SPARK Test to evaluate its ability to detect cognitive impairment, such as problems with thinking and memory. The test uses a special cap and equipment to record brain activity while participants sit quietly with their eyes open or closed. Suitable candidates are those aged 55 to 85 who have been diagnosed with cognitive issues, such as memory or thinking difficulties, and can remain still for about 30 minutes. It is important for participants to have someone who knows them well, like a family member or friend, to provide information about their sleep and cognitive habits. Participants should not be on certain medications or have conditions that might interfere with the study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance the understanding and detection of cognitive issues.

Will I have to stop taking my current medications?

Yes, if you are taking certain medications like opiates, benzodiazepines, or antipsychotics, you will need to stop them to participate in the trial. The trial requires a 'washout' period, meaning you must be off these medications for a certain time before joining.

What prior data suggests that the SPARK Test is safe for cognitive impairment assessment?

Research has shown that the SPARK Test uses special software with an FDA-approved EEG device to record brain activity. This approval indicates a certain level of safety. Although researchers are still studying the software, studies have not reported serious side effects or safety issues. Since the SPARK Test is neither a drug nor an invasive procedure, the risks are likely low. Overall, current information suggests that people generally tolerate the SPARK Test well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SPARK Test for cognitive impairment because it offers a new way to evaluate cognitive function using EEG technology with both open and closed eyes. Unlike traditional cognitive assessments that rely on questionnaires and subjective evaluation, the SPARK Test provides objective data through brainwave analysis. This method could potentially lead to more accurate and early detection of cognitive issues, which is crucial for timely intervention and treatment.

What evidence suggests that the SPARK Test is effective for cognitive impairment?

Studies have shown that the SPARK Test, which participants in this trial will undergo, can accurately help diagnose dementia. It uses advanced software to analyze brain waves through an EEG, a test that records the brain's electrical activity. Research indicates that SPARK's technology can identify people at high risk for dementia early, allowing for more focused care. Initial findings suggest that this method provides a more accurate diagnosis, crucial for creating personalized treatment plans. Additionally, the technology has successfully assessed cognitive levels in children with autism, demonstrating its versatility. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

The SPARK Neuro REMIND Study is for individuals aged 55 to 85 with cognitive impairment or Alzheimer's, who have someone willing to report on their sleep and cognition. Participants must be able to consent and follow the study protocol. Exclusions include inability to stay still for EEG, certain medical conditions, substance use disorders, and specific medications.

Inclusion Criteria

I am between 55 and 85 years old.

I have someone who can report on my sleep and thinking skills.

Subject or Legally Authorized Representative (LAR) has the ability to provide informed consent and comply with the protocol.

Exclusion Criteria

I have epilepsy or a long-term seizure disorder.

Medical or psychiatric illness that would interfere with study participation

You have metal in your head that is not related to dental work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

EEG Data Collection

Participants undergo EEG data collection using the SPARK Test with an EEG amplifier and cap

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after EEG data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SPARK Test

Trial Overview This trial tests the SPARK Test software used alongside an FDA-cleared EEG system. It aims to collect and analyze brain activity data (EEG) from participants in order to understand cognitive impairments better.

How Is the Trial Designed?

Group I: Subjects - Variable Cognitive Status Experimental Treatment 1 Intervention

Subjects meeting Inclusion/Exclusion criteria with open eyes/closed eyes EEG collection.

SPARK Test is already approved in United States for the following indications:

Approved in United States as SPARK Test for:

• Investigational use in collecting and analyzing EEG data

Approved in United States as SPARK Test for:

• Investigational use in collecting and analyzing EEG data

Who Is Running the Clinical Trial?

Spark Neuro Inc.

Lead Sponsor

Trials

4

Recruited

1,500+

Published Research Related to This Trial

The Test Your Memory (TYM) and Test Your Memory for Mild Cognitive Impairment (TYM-MCI) are effective short cognitive tests that can help differentiate Alzheimer's disease from other memory issues in a clinical setting.

The TYM test, including its tele-adapted version, shows strong correlation with the established ACE-R test and can effectively identify dementia, with Alzheimer's patients declining at a rate of 3.6-4.1 points per year on the TYM test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test Your Memory (TYM) and Test Your Memory for Mild Cognitive Impairment (TYM-MCI): A Review and Update Including Results of Using the TYM Test in a General Neurology Clinic and Using a Telephone Version of the TYM Test. Brown, JM., Wiggins, J., Dawson, K., et al.[2020]

The 7 Minute Screen, a rapid neurocognitive test battery, demonstrated 100% sensitivity and specificity in distinguishing between patients with probable Alzheimer's disease and healthy controls, based on a study of 120 participants (60 with AD and 60 controls).

The test showed strong reliability, with interrater reliability at 0.92 and test-retest reliability at 0.91, making it a reliable tool for initial cognitive assessments without requiring extensive training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 7 minute neurocognitive screening battery highly sensitive to Alzheimer's disease. Solomon, PR., Hirschoff, A., Kelly, B., et al.[2022]

A shortened picture version of the Free and Cued Selective Reminding Test (FCSRT) effectively distinguishes patients with amnestic mild cognitive impairment (aMCI) from controls, even among individuals with low levels of schooling, as demonstrated in a study of 60 participants.

The diagnostic accuracy of this test is high, with an area under the curve of 0.99 for free recall, indicating it is a reliable tool for assessing memory function in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary analysis of a shortened picture version of the Free and Cued Selective Reminding Test. Rodrigo-Herrero, S., Mendez-Barrio, C., Bernal Sánchez-Arjona, M., et al.[2021]

A shortened picture version of the Free and Cued Selective Reminding Test (FCSRT) effectively distinguishes patients with amnestic mild cognitive impairment (aMCI) from controls, even among individuals with low levels of schooling, based on a study of 60 participants.

The diagnostic accuracy of this test is high, with an area under the curve of 0.99 for free recall, indicating it is a reliable tool for assessing memory function in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary analysis of a shortened picture version of the Free and Cued Selective Reminding Test. Rodrigo-Herrero, S., Mendez-Barrio, C., Bernal Sánchez-Arjona, M., et al.[2022]

There is a growing need for more sensitive cognitive assessments for Alzheimer's disease, especially for individuals with mild or no cognitive impairment, as traditional tests have not led to significant treatment advancements.

Automated cognitive tests can effectively assess cognitive performance without causing stress to older individuals or dementia patients, and they offer advantages in clinical trials by measuring the speed of cognitive processes, suggesting they should be considered equally alongside non-automated tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving beyond the pros and cons of automating cognitive testing in pathological aging and dementia: the case for equal opportunity. Wesnes, KA.[2022]

The newly developed delayed word recall (DWR) test shows a high predictive accuracy of 95.2% in distinguishing between patients with Alzheimer's disease and normal elderly individuals.

The DWR test is designed to be brief and efficient, requiring elaborative processing, which enhances its effectiveness for early detection of Alzheimer's while minimizing the influence of age or education on normal subjects' performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A verbal memory test with high predictive accuracy for dementia of the Alzheimer type. Knopman, DS., Ryberg, S.[2022]

The Slovenian version of the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) was validated with 128 participants, showing high sensitivity (88%) and specificity (85%) for detecting mild cognitive impairment (MCI) with a cut-off score of 10/11 points.

For Alzheimer's disease (AD), the ADAS-Cog demonstrated even higher effectiveness, with a cut-off score of 11/12 points yielding 100% sensitivity and 95% specificity, confirming its reliability in distinguishing AD patients from healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Slovenian version of ADAS-Cog for patients with mild cognitive impairment and Alzheimer's disease. Ulbl, J., Rakusa, M.[2022]

In a study of 185 patients with mild cognitive impairment (MCI), cued recall measures, particularly from the Free and Cued Selective Reminding Test (FCSRT), were found to be the most effective in distinguishing between patients with Alzheimer's disease (AD) biomarkers in their cerebrospinal fluid (CSF) and those without.

The findings suggest that deficits in cued recall are closely linked to Alzheimer's disease indicators, supporting the use of cued recall as a specific marker for early detection of AD in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarker validation of a cued recall memory deficit in prodromal Alzheimer disease. Wagner, M., Wolf, S., Reischies, FM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05406778

The REMIND Study- SPARK Neuro Software Study The aim of this study is to collect data to support development of an algorithm to determine whether applying machine-learning techniques to ...

2. sparkneuro.com sparkneuro.com/remindv-study/

You can help impact the Science of Brain Health The REMIND-V Study aims to evaluate investigational software innovations in brain health monitoring technology. Whether you have normal thinking or mild memory ...

3. sparkneuro.com sparkneuro.com/

Home - SPARK Neuro - Setting a new standard in cognitive care The SPARK Solution: Smarter Dementia Diagnosis for Better Care, Targeted Care, SPARK identifies high-risk members early for more proactive, tailored care.

4. sparkneuro.com sparkneuro.com/science/

SPARK Neuro - Setting a new standard in cognitive care SPARK supports patients and clinicians alike by providing highly accurate and accessible dementia diagnosis. Built on top of our proprietary machine-learning ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34636158/

Imputing cognitive impairment in SPARK, a large autism ... We show cognitive levels can be imputed with high accuracy for children with autism, using commonly collected parent-reported data and standardized surveys.

6. withpower.com withpower.com/trial/spark-cognitive-status-indicator-for-dementia-112f4

SPARK Cognitive Status Indicator for Dementia · Info ... This study will compare SPARK Cognitive Status Indicator output to Adjudication Committee panel-based diagnosis of cognitive status and Alzheimer's disease.