Normative Database and Test-Retest Reliability for BrainCheck Assessments (NDTR)

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Change; Cognitive Decline; Cognitive Deterioration; Neurocognitive Deficit
• Intervention / Treatment: Device: BrainCheck Assessment

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 Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Kevin Sun; Phone Number: 281-616-5206; Email: study@braincheck.com
• Study Contact Backup: Name: Bin Huang, PhD; Phone Number: 8323038175; Email: bin@braincheck.com

Study Locations

• United States
  • Connecticut
    • Multiple Locations, Connecticut, United States, 06880
      • Recruiting
      • Maplewood Senior Living
      • Contact: Kevin Sun
  • Texas
    • Austin, Texas, United States, 78702
      • Recruiting
      • BrainCheck
      • Contact: Kevin Sun
    • Houston, Texas, United States, 77005
      • Recruiting
      • BrainCheck
      • Contact: Kevin Sun
  • Washington
    • Mountlake Terrace, Washington, United States, 98043
      • Recruiting
      • BrainCheck
      • Contact: Kevin Sun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of healthy volunteers 50 years of age or older.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BrainCheck, Inc.

Publications and helpful links

Helpful Links

• More information on the study and signup

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Mild Cognitive Impairment; Healthy Volunteers; Older Adults; Dementia
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: Pro00064230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes