Cognitive ChangeNDTRNCT05497427
Normative Database and Test-Retest Reliability for BrainCheck Assessments
An observational study of Cognitive Change and Cognitive Decline, run by BrainCheck, Inc. at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Cognitive Decline, Cognitive Deterioration
- What is being tested?
- BrainCheck Assessment
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 1,300 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Oct 2022to 17 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of healthy volunteers 50 years of age or older.
Who may be able to join
- Aged 50 or older
- Willing and able to comply with study requirements and activities
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
BrainCheck
Austin, Texas, 78702
BrainCheck
Houston, Texas, 77005
Maplewood Senior Living
Multiple Locations, Connecticut, 06880
BrainCheck
Palo Alto, California, 94301
BrainCheck
Seattle, Washington, 98105
About this study
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.
Read the 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.
- Being tested
- BrainCheck Assessment
- Keywords
- Healthy Volunteers, Dementia, Alzheimer's Disease, Mild Cognitive Impairment, Older Adults
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainCheck AssessmentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: Device: BrainCheck Assessment | |
| Test-Retest | Comparing BrainCheck assessment values between an initial visit test and a follow-up visit test 7-14 days later within subjects. Receives: Device: BrainCheck Assessment | |
| Per Protocol | BrainCheck assessment values from participants that completed all procedures with no protocol deviations Receives: Device: BrainCheck Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (1)
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start10 Oct 2022
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainCheck, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497427
- Sponsor's protocol ID
- Pro00064230
- Acronym
- NDTR
- Status last verified
- Dec 2025
- First submitted
- 5 Aug 2022
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Database and Test-Retest Reliability for BrainCheck Assessments
- ClinicalTrials.gov ID
- NCT05497427
- Acronym / sponsor ID
- NDTR / Pro00064230
- Keywords
- Healthy Volunteers, Dementia, Alzheimer's Disease, Mild Cognitive Impairment, Older Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- BrainCheck, Inc.University, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normative | – | Device: BrainCheck AssessmentBrainCheck 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.) |
| Test-Retest | – | Device: BrainCheck AssessmentComparing BrainCheck assessment values between an initial visit test and a follow-up visit test 7-14 days later within subjects. |
| Per Protocol | – | Device: BrainCheck AssessmentBrainCheck assessment values from participants that completed all procedures with no protocol deviations |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of healthy volunteers 50 years of age or older.
Key inclusion criteria (2 listed)
- Aged 50 or older
- Willing and able to comply with study requirements and activities
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainCheck AssessmentA 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 | Device | Normative, Per Protocol, Test-Retest |
Primary outcome
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.
1 secondary outcome
Test-retest reliability of BrainCheck Assessment values between two different time points
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- More information on the study and signupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Change and Cognitive Decline, run by BrainCheck, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean, standard deviation, and percentiles of values of BrainCheck Assessments (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.