Healthy VolunteersNCT02382393
Reliability and Validity of Online Cognitive Assessments
A study testing Brain Performance Test (BPT, Lumos Labs, Inc) and Computerized Assessment in people with Healthy Volunteers, run by Lumos Labs, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the concurrent validity (correlation coefficient of scores at 1 time point) between the Brain Performance Test (BPT, Lumos Labs, Inc.) and a validated third party computerized assessment. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Brain Performance Test (BPT, Lumos Labs, Inc) and Computerized Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,152 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Nov 2015
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Electronically signed informed consent
- 18 years of age or older
- Native English-Speaker
- Consistent access to a computer with stable internet connection
Who cannot join
- Under 18 years of age
- Native language other than English
- Visual impairment that impedes computer use
- Has taken a cognitive assessment or done cognitive training in the past year
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the concurrent validity (correlation coefficient of scores at 1 time point) between the Brain Performance Test (BPT, Lumos Labs, Inc.) and a validated third party computerized assessment.
Read the detailed description
Each subject will complete two sessions, each approximately 1 hour in total duration, approximately 2 weeks apart for a total duration of participation of 2 hours over 2 weeks
- Conditions
- Healthy Volunteers
- Being tested
- Brain Performance Test (BPT, Lumos Labs, Inc), Computerized Assessment
- Keywords
- cognitive assessment, Brain Performance Test, Lumosity, concurrent validity, computerized assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Performance Test (BPT, Lumos Labs, Inc)Other
A brief, repeatable, online battery of cognitive assessments used to measure functioning in five cognitive domains across time.
Computerized AssessmentOther
a validated, computerized cognitive assessment tool
| Study group | Role | What they receive |
|---|---|---|
| BPT, Computerized Assessment | Experimental | Participants will first take the Brain Performance Test (BPT) and then a third party validated assessment battery. Receives: Other: Brain Performance Test (BPT, Lumos Labs, Inc); Other: Computerized Assessment |
| Computerized Assessment, BPT | Experimental | Participants will take a third party validated assessment battery and then the Brain Performance Test (BPT). Receives: Other: Brain Performance Test (BPT, Lumos Labs, Inc); Other: Computerized Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
BPT Grand Index Score at Time 1
Measured: Baseline
Computerized Assessment Index at Time 1
Measured: Baseline
Selected raw and scaled BPT and Computerized Assessment matched subtest scores at Time 1
Measured: Baseline
Secondary outcomes (3)
BPT Grand Index at Time 1 and Time 2
Measured: Baseline to 2 weeks
Computerized Assessment Index at Time 1 and Time 2
Measured: Baseline to 2 weeks
Raw and scaled BPT subtest scores at Time 1 and Time 2
Measured: Baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Morrison, PhD, Principal investigator, Lumos Labs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382393
- Sponsor's protocol ID
- LL002(p)
- Status last verified
- Nov 2015
- First submitted
- 3 Mar 2015
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Online Cognitive Assessments
- ClinicalTrials.gov ID
- NCT02382393
- Acronym / sponsor ID
- LL002(p)
- Conditions
- Healthy Volunteers
- Keywords
- cognitive assessment, Brain Performance Test, Lumosity, concurrent validity, computerized assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,152 participants (actual)
- Lead sponsor
- Lumos Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 Mar 2015 (estimated)
- 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 evaluate the concurrent validity (correlation coefficient of scores at 1 time point) between the Brain Performance Test (BPT, Lumos Labs, Inc.) and a validated third party computerized assessment.
Detailed description
Each subject will complete two sessions, each approximately 1 hour in total duration, approximately 2 weeks apart for a total duration of participation of 2 hours over 2 weeks
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPT, Computerized Assessment | Experimental | Other: Brain Performance Test (BPT, Lumos Labs, Inc), Other: Computerized AssessmentParticipants will first take the Brain Performance Test (BPT) and then a third party validated assessment battery. |
| Computerized Assessment, BPT | Experimental | Other: Brain Performance Test (BPT, Lumos Labs, Inc), Other: Computerized AssessmentParticipants will take a third party validated assessment battery and then the Brain Performance Test (BPT). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Electronically signed informed consent
- 18 years of age or older
- Native English-Speaker
- Consistent access to a computer with stable internet connection
Key exclusion criteria (4 listed)
- Under 18 years of age
- Native language other than English
- Visual impairment that impedes computer use
- Has taken a cognitive assessment or done cognitive training in the past year
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 |
|---|---|---|
| Brain Performance Test (BPT, Lumos Labs, Inc)A brief, repeatable, online battery of cognitive assessments used to measure functioning in five cognitive domains across time. | Other | BPT, Computerized Assessment, Computerized Assessment, BPT |
| Computerized Assessmenta validated, computerized cognitive assessment tool | Other | BPT, Computerized Assessment, Computerized Assessment, BPT |
Primary outcome
BPT Grand Index Score at Time 1
Time frame: Baseline
Computerized Assessment Index at Time 1
Time frame: Baseline
Selected raw and scaled BPT and Computerized Assessment matched subtest scores at Time 1
Time frame: Baseline
3 secondary outcomes
BPT Grand Index at Time 1 and Time 2
Time frame: Baseline to 2 weeks
Computerized Assessment Index at Time 1 and Time 2
Time frame: Baseline to 2 weeks
Raw and scaled BPT subtest scores at Time 1 and Time 2
Time frame: Baseline to 2 weeks
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 13 Nov 2015.
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Screening Protocol
Pain
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.
Glenn Morrison, PhD principal investigator
Lumos Labs, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Performance Test (BPT, Lumos Labs, Inc) and Computerized Assessment in people with Healthy Volunteers, run by Lumos Labs, Inc. at 1 site 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 4 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 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
BPT Grand Index Score at Time 1 (time frame: Baseline). The study lists 3 primary outcomes in all. 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 13 Nov 2015.