Normative Database and Test-Retest Reliability for BrainCheck Assessments

Study Overview
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Brief Summary
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The purpose of this study is to collect normative test values and demographic information for normative and referential data for a rapid, portable, computerized neurocognitive testing device from healthy adults 50 and older.

Detailed Description
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BrainCheck's battery of 12 cognitive assessments will be used in this study, which aims to measure a variety of cognitive domains (memory, attention, mental flexibility, executive function, processing speed, balance, reasoning, visuospatial construction, language, and visual hallucinations). With the decline in cognition occurring at a quicker rate at older ages, this study aims to collect additional data from healthy older adults to better capture the normative distribution among these age groups from existing and new assessments.

Official Title
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Normative Database and Test-Retest Reliability for BrainCheck Assessments

Conditions
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Cognitive Change, Cognitive Decline, Cognitive Deterioration, Neurocognitive Deficit

Intervention / Treatment
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* Device: BrainCheck Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 50 or older Willing and able to comply with study requirements and activities Exclusion Criteria: TBI within the last 6 months Neurosurgery within the last month Experienced a stroke Self reported neurological condition (including mild neuropsychological impairment, dementia, Parkinson's disease, amyotrophic lateral sclerosis, Multiple sclerosis, or long-covid)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normative<br>BrainCheck assessment values from participants that have indications of healthy cognition at the time of testing ( a SLUMS result considered 'normal', more than 4 hours of sleep the night before, not having consumed alcohol or drugs within the last 6 hours, or not have participated in high capacity and strenuous physical activity within the last hour.) | Device: BrainCheck Assessment<br>* A computerized neurocognitive test administered via an electronic device, such as a phone, tablet or computer, that contains several assessments that will aid in establishing an individuals cognitive performance<br>|
| Test-Retest<br>Comparing BrainCheck assessment values between an initial visit test and a follow-up visit test 7-14 days later within subjects. | Device: BrainCheck Assessment<br>* A computerized neurocognitive test administered via an electronic device, such as a phone, tablet or computer, that contains several assessments that will aid in establishing an individuals cognitive performance<br>|
| Per Protocol<br>BrainCheck assessment values from participants that completed all procedures with no protocol deviations | Device: BrainCheck Assessment<br>* A computerized neurocognitive test administered via an electronic device, such as a phone, tablet or computer, that contains several assessments that will aid in establishing an individuals cognitive performance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean, standard deviation, and percentiles of values of BrainCheck Assessments | BrainCheck Assessment values will be calculated by descriptive statistics. Mean, standard deviation, and percentiles (1, 5, 10, 25, 50, 75, 90, 95, 99) of the scores will be calculated for each individual assessment. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-retest reliability of BrainCheck Assessment values between two different time points | Evaluate the test-retest reliability of BrainCheck assessments using Pearson Correlation coefficients on the descriptive statistics of each individual assessment. | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, Dementia, Alzheimer's Disease, Mild Cognitive Impairment, Older Adults