Normative Database and Test-Retest Reliability for BrainCheck Assessments
NDTR
1 other identifier
observational
1,300
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2022
CompletedFirst Posted
Study publicly available on registry
August 11, 2022
CompletedStudy Start
First participant enrolled
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2025
CompletedJanuary 2, 2026
December 1, 2025
3 years
August 5, 2022
December 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Test-retest reliability of BrainCheck Assessment values between two different time points
5 months
Study Arms (3)
Normative
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.)
Test-Retest
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 values from participants that completed all procedures with no protocol deviations
Interventions
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
Eligibility Criteria
The study population will consist of healthy volunteers 50 years of age or older.
You may qualify if:
- Aged 50 or older
- Willing and able to comply with study requirements and activities
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BrainCheck, Inc.lead
Study Sites (5)
BrainCheck
Palo Alto, California, 94301, United States
Maplewood Senior Living
Multiple Locations, Connecticut, 06880, United States
BrainCheck
Austin, Texas, 78702, United States
BrainCheck
Houston, Texas, 77005, United States
BrainCheck
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2022
First Posted
August 11, 2022
Study Start
October 10, 2022
Primary Completion
October 17, 2025
Study Completion
October 17, 2025
Last Updated
January 2, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share