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Clinical Trials/NCT05497427
NCT05497427
Completed
Not Applicable

Normative Database and Test-Retest Reliability for BrainCheck Assessments

BrainCheck, Inc.2 sites in 1 country1,300 target enrollmentOctober 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Change
Sponsor
BrainCheck, Inc.
Enrollment
1300
Locations
2
Primary Endpoint
Mean, standard deviation, and percentiles of values of BrainCheck Assessments
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 10, 2022
End Date
October 17, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
BrainCheck, Inc.
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Mean, standard deviation, and percentiles of values of BrainCheck Assessments

Time Frame: 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 Outcomes

  • Test-retest reliability of BrainCheck Assessment values between two different time points(5 months)

Study Sites (2)

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