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

BrainCheck, Inc.

Status: Enrolling

Conditions: Cognitive Change; Neurocognitive Deficit; Cognitive Decline; Cognitive Deterioration

Treatments: Device: BrainCheck Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT05497427

Pro00064230

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

1,200 participants in 3 patient groups

Normative

Description:

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.)

Treatment:

Device: BrainCheck Assessment

Test-Retest

Description:

Comparing BrainCheck assessment values between an initial visit test and a follow-up visit test 7-14 days later within subjects.

Treatment:

Device: BrainCheck Assessment

Per Protocol

Description:

BrainCheck assessment values from participants that completed all procedures with no protocol deviations

Treatment:

Device: BrainCheck Assessment