Alzheimer Disease, Cognitive Impairment
Conditions
Keywords
EEG, Electroencephalography, Machine learning
Brief 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.
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.
Interventions
DEVICESPARK Test
Thirty (30) minutes of resting state EEG data collection.
Sponsors
Spark Neuro Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes
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 craniotomy 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. Subject meets at least one of the following criteria: 1. Diagnosis of cognitive impairment from various underlying pathologies as indicated by one of the diagnostic codes listed in Appendix A (protocol) 2. MMSE score of 27 or less 3. 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 9. Substance Use Disorder, including Alcohol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG Data collection for AI software development | During the diagnostic procedure | Rate of complete software collection per enrolled subjects complete a SPARK Test recording. |
Countries
United States
Outcome results
None listed