SPARK Test for Cognitive Impairment

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

800 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the SPARK Test treatment for cognitive impairment?

Automated cognitive tests, like the SPARK Test, have been shown to effectively assess cognitive function in older individuals and patients with dementia without causing stress or disadvantage. These tests can evaluate all aspects of task performance, including the speed of cognitive processes, which can be beneficial in clinical trials. ^{1 2 3 4 5}

How is the SPARK Test treatment different from other treatments for cognitive impairment?

The SPARK Test is unique because it uses specialized software to assess cognitive function, focusing on memory and other mental skills, rather than being a medication or traditional therapy. This approach is different from standard treatments that often involve drugs or physical therapies. ^{3 4 6 7 8}

Eligibility Criteria

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 a problem with using drugs or alcohol.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: TBD Experimental Treatment 1 Intervention

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

References

1. England 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Biomarker validation of a cued recall memory deficit in prodromal Alzheimer disease. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

Preliminary analysis of a shortened picture version of the Free and Cued Selective Reminding Test. [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

Preliminary analysis of a shortened picture version of the Free and Cued Selective Reminding Test. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A verbal memory test with high predictive accuracy for dementia of the Alzheimer type. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A 7 minute neurocognitive screening battery highly sensitive to Alzheimer's disease. [2022]

7. Switzerland 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. [2020]

8. Italy pubmed.ncbi.nlm.nih.gov

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