The REMIND Study- SPARK Neuro Software Study

Completed · Not applicable

Conditions studied: Alzheimer Disease, Cognitive Impairment

In brief

The study utilizes investigational software, the SPARK Test, with an FDA-cleared electroencephalography (EEG) amplifier and EEG cap to collect and patient EEG data.

Key facts

Study ID

NCT05406778

Run by

Spark Neuro Inc.

People needed

185

Starts

2022-05-18

Expected to finish

2024-01-19

Last updated by the study team

2025-08-14

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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

Where it is running

• Island Psych — Loma Linda, California, United States
• CenExel Rocky Mountain — Englewood, Colorado, United States
• Renstar Medical — Ocala, Florida, United States
• Arcturus Healthcare PLC, Troy - Internal Medicine Division — Troy, Michigan, United States
• Alivation Health — Lincoln, Nebraska, United States
• Advanced Neuro — El Paso, Texas, United States
• Integrated Neurology — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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