Normative Database and Test-Retest Reliability for BrainCheck Assessments

Cognitive Decline Clinical Trial

— NDTR  

Official title:

Normative Database and Test-Retest Reliability for BrainCheck Assessments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05497427
• Other study ID #: Pro00064230
• Status: Recruiting
• Start date: October 10, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: BrainCheck, Inc.
• Contact: Kevin Sun
• Phone: 281-616-5206
• Email: study[@]braincheck.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Change
• Cognitive Decline
• Cognitive Deterioration
• Cognitive Dysfunction
• Neurocognitive Deficit

Intervention

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

Locations

Country	Name	City	State
United States	BrainCheck	Austin	Texas
United States	BrainCheck	Houston	Texas
United States	BrainCheck	Mountlake Terrace	Washington
United States	Maplewood Senior Living	Multiple Locations	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
BrainCheck, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   More information on the study and signup