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

B

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

Trial contacts and locations

5

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Central trial contact

Kevin Sun; Bin Huang, PhD

Data sourced from clinicaltrials.gov

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