NCT06809725Enrolling by invitation
Software Validation Study-Cognitive Status Indicator
Validation of the SPARK Scan Cognitive Status Indicator Software Concordance With Clinical Diagnosis in Humans With Unimpaired, Mild Cognitive Impairment and Dementia Status, With and Without Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The SPARK Cognitive Status Indicator software uses an algorithm to assess a resting state EEG recording as being consistent with a cognitive status of unimpaired, mild cognitive impairment (MCI; MCI AD- or MCI AD+), or dementia (dementia AD-, or dementia AD+). This study will compare SPARK Cognitive Status Indicator output to Adjudication Committee panel-based diagnosis of cognitive status and Alzheimer's disease.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- 31 Mar 2025
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Spark Neuro Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT06809725
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 31 Mar 2025 to the primary completion date, 1 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 1\. Currently experiencing a skin disease on scalp that would affect electrode contacts in the opinion of the user
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- \-
Who the study is looking for
- Unimpaired subjects:
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 65 to 90 at the time of consent
- Have a Salzburg Dementia Test Prediction (SDTP) score \>= 24.
- Informant, available and willing (remotely or in-person) to provide information about subject cognitive functioning
- No Medical History of cognitive impairment
- Mild Cognitive Impairment subjects:
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- 1\. Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 65 to 90 at the time of consent
- Have a Salzburg Dementia Test Prediction (SDTP) score \< 24.
- Informant, available and willing (remotely or in-person) to provide information about subject cognitive functioning
- Suspected or diagnosed with a mild cognitive issue
- Dementia subjects:
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form-legally authorized representative or individual
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 65 to 90 at the time of consent
- Have a Salzburg Dementia Test Prediction (SDTP) score \< 24.
- Informant, available and willing (remotely or in-person) to provide information about subject cognitive functioning
- Exhibiting and diagnosed with moderate or severe cognitive issue
- Informants:
- To be eligible to participate as an informant in this study, an individual must meet all of the following criteria:
- 1\. Provision of signed and dated informed consent form 2. Typically spends 2 or more hours per month with subject. 3. Available and willing (remotely or in-person) to provide information about subject cognitive functioning
- \-
Age in the registry: 65 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Remote Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.