Using EEG and machine learning to assess cognitive status in Alzheimer's patients
SPARK Neuro Quantitative Resting State EEG Protocol for Assessing Cognitive Impairment and AD Status 'REMIND' Study
This study is testing a new way to use brain wave readings from EEG to see if it can help identify Alzheimer's disease in people aged 55 to 85.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Sponsor | Spark Neuro Inc. Industry-sponsored |
| Locations | 1 site (Tempe, Arizona) |
| Trial ID | NCT05406778 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and evaluate an algorithm that utilizes machine-learning techniques applied to resting-state electroencephalography (EEG) data to characterize cognitive status and detect Alzheimer's Disease (AD). Participants aged 55 to 85 will undergo EEG testing using the SPARK Test, which includes an FDA-cleared EEG amplifier and cap. The study will analyze the collected EEG data to determine its effectiveness in identifying the presence or absence of AD. The approach combines advanced technology with clinical assessment to enhance diagnostic capabilities for cognitive impairment.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 55 to 85 who have a reliable informant to provide information about their cognitive functioning.
Not a fit: Patients with significant neurological conditions or those unable to remain still during EEG recording may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive and efficient method for early detection of Alzheimer's Disease.
How similar studies have performed: Other studies have shown promise in using EEG and machine learning for cognitive assessment, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 55 to 85 at the time of consent 2. 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 3. Subject or Legally Authorized Representative (LAR) has the ability to provide informed consent and comply with the protocol. Exclusion Criteria: 1. Unable to remain still for up to 30 minutes during EEG data recording 2. 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 3. Previous history of stroke, severe head injury, craniotomy or any other potentially confounding neurologic illness causing known structural brain damage 4. Medical or psychiatric illness that would interfere with study participation 5. History of epilepsy or chronic seizure disorder 6. Presence of non-dental metal in head 7. Currently experiencing a skin disease on scalp that would affect electrode contacts 8. TICS score indicative of cognitive impairment at screening 9. Substance Use Disorder, including Alcohol
Where this trial is running
Tempe, Arizona
- Voyage Medical — Tempe, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Marinela Gombosev
- Email: study1001@sparkneuro.com
- Phone: 929-515-6003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.