Normative Database and Test-Retest Reliability for BrainCheck Assessments

Recruiting

• Conditions: Cognitive Change; Neurocognitive Deficit; Cognitive Decline; Cognitive Deterioration
• Interventions: Device: BrainCheck Assessment

• Registration Number: NCT05497427
• Lead Sponsor: BrainCheck, Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2022-10-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Test-Retest	BrainCheck Assessment	Comparing BrainCheck assessment values between an initial visit test and a follow-up visit test 7-14 days later within subjects.
Per Protocol	BrainCheck Assessment	BrainCheck assessment values from participants that completed all procedures with no protocol deviations
Normative	BrainCheck Assessment	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.)

Primary Outcome Measures

Name	Time	Method
Mean, standard deviation, and percentiles of values of BrainCheck Assessments	5 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

BrainCheck; 🇺🇸 Seattle, Washington, United States

Maplewood Senior Living; 🇺🇸 Multiple Locations, Connecticut, United States