CognitionBRIGHT-MindNCT05912556
Brain Response to an Intervention Using Guided, At-Home Technology for the Mind
A study testing Digital Program 1 and Digital Program 2 in people with Cognition and Brain Health, run by Lumos Labs, Inc. at 1 site in United States.
Trial summary
The objective of this study is to assess the effectiveness of two digital programs for providing mental stimulation, improving cognition, and inducing changes in brain structure and function. Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Brain Health, Brain Structure
- What is being tested?
- Digital Program 1 and Digital Program 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 817 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 11 Mar 2025
- 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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects 25-80 years of age.
- Ability to understand and speak English, follow written and verbal instructions (English), and give informed consent (English), as assessed by study staff.
- Ability to comply with all the testing and study requirements, including the ability to independently use a video conferencing tool and the ability to independently use a computer to access the web.
- Ability to independently complete a daily, online intervention and outcome assessments using a web browser compatible with the intervention and assessment software on a reliable, internet-connected laptop or desktop computer.
Who cannot join
- Current, controlled (requiring treatment) or uncontrolled psychiatric diagnosis, including but not limited to posttraumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, attention-deficit/hyperactivity disorder, or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments.
- Current, controlled (requiring treatment) or uncontrolled neurological diagnosis, including but not limited to Alzheimer's Disease, other dementias, mild cognitive impairment, Huntington's Disease, Parkinson's Disease, multiple sclerosis, stroke, epilepsy, aphasia, or other condition that in the opinion of the Investigator may confound study data/assessments.
- Any other medical condition in the last 90 days that in the opinion of the Investigator may confound study data/assessments.
- Has been under the care of a caretaker or has not been living independently in the last 90 days.
- In the last three years has used any of the following for more than two weeks continuously: Online courses, Online brain training programs
- Known sensitivity (such as headaches, dizziness, nausea) to bright, stimulating video displays.
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- History of seizures (excluding febrile seizures), or significant motor or vocal tics, including but not limited to Tourette's Disorder and photo-sensitive epilepsy.
- Visual acuity that cannot be corrected that prevents or negatively impacts computer activity.
- Has participated in a clinical trial within 90 days prior to screening.
- Pregnancy or planning to become pregnant.
- Additional Exclusion Criteria for Cohort B only:
- Unwillingness or inability to comply with imaging safety protocols.
- Metal implants or exposure to shrapnel.
- Left-handed or ambidextrous.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Response to an Intervention Using Guided, At-Home Technology for the Mind - A Randomized, Controlled, Double-blinded, Parallel-group Intervention Study to Assess an At-Home Program for Improving Cognition and Inducing Changes in Brain Structure and Function
The objective of this study is to assess the effectiveness of two digital programs for providing mental stimulation, improving cognition, and inducing changes in brain structure and function.
- Conditions
- Cognition, Brain Health, Brain Structure, Brain Function
- Being tested
- Digital Program 1, Digital Program 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Program 1Device
2/3 of randomized subjects use digital program 1 for 12 weeks to provide mental stimulation
Digital Program 2Device
1/3 of randomized subjects use digital program 2 for 12 weeks to provide mental stimulation
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Other | Remote-Only subjects Receives: Device: Digital Program 1; Device: Digital Program 2 |
| Cohort B | Other | Remote + Imaging subjects Receives: Device: Digital Program 1; Device: Digital Program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Composite from Creyos (formerly Cambridge Brain Sciences)
The Overall Composite is derived from the 12 tests in the Creyos battery.
Measured: Study Day 0 to Study Day 84
Secondary outcomes (7)
Concentration Domain Score from Creyos
Measured: Study Day 0 to Study Day 84
Memory Domain Score from Creyos
Measured: Study Day 0 to Study Day 84
Planning Domain Score from Creyos
Measured: Study Day 0 to Study Day 84
Reasoning Domain Score from Creyos
Measured: Study Day 0 to Study Day 84
Structural Brain Composite from Magnetic Resonance Imaging (MRI)
Brain-predicted age difference (Brain-PAD)
Measured: Study Day 0 to Study Day 84
White Matter Microstructure Composite from Diffusion Magnetic Resonance Imaging (dMRI)
Measured: Study Day 0 to Study Day 84
Within-Network Functional Connectivity from Resting-State functional Magnetic Resonance Imaging (fMRI)
Measured: Study Day 0 to Study Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start17 Jul 2023
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Madore, PhD, Principal investigator, Lumos Labs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912556
- Sponsor's protocol ID
- LL-015
- Acronym
- BRIGHT-Mind
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in the primary research article and its supplementary information, together with an accompanying data dictionary, will be openly available in a public repository.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Response to an Intervention Using Guided, At-Home Technology for the Mind - A Randomized, Controlled, Double-blinded, Parallel-group Intervention Study to Assess an At-Home Program for Improving Cognition and Inducing Changes in Brain Structure and Function
- ClinicalTrials.gov ID
- NCT05912556
- Acronym / sponsor ID
- BRIGHT-Mind / LL-015
- Conditions
- Cognition, Brain Health, Brain Structure, Brain Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- Lumos Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 22 Jun 2023 (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 objective of this study is to assess the effectiveness of two digital programs for providing mental stimulation, improving cognition, and inducing changes in brain structure and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Other | Device: Digital Program 1, Device: Digital Program 2Remote-Only subjects |
| Cohort B | Other | Device: Digital Program 1, Device: Digital Program 2Remote + Imaging subjects |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects 25-80 years of age.
- Ability to understand and speak English, follow written and verbal instructions (English), and give informed consent (English), as assessed by study staff.
- Ability to comply with all the testing and study requirements, including the ability to independently use a video conferencing tool and the ability to independently use a computer to access the web.
- Ability to independently complete a daily, online intervention and outcome assessments using a web browser compatible with the intervention and assessment software on a reliable, internet-connected laptop or desktop computer.
Key exclusion criteria (14 listed)
- Current, controlled (requiring treatment) or uncontrolled psychiatric diagnosis, including but not limited to posttraumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, attention-deficit/hyperactivity disorder, or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments.
- Current, controlled (requiring treatment) or uncontrolled neurological diagnosis, including but not limited to Alzheimer's Disease, other dementias, mild cognitive impairment, Huntington's Disease, Parkinson's Disease, multiple sclerosis, stroke, epilepsy, aphasia, or other condition that in the opinion of the Investigator may confound study data/assessments.
- Any other medical condition in the last 90 days that in the opinion of the Investigator may confound study data/assessments.
- Has been under the care of a caretaker or has not been living independently in the last 90 days.
- In the last three years has used any of the following for more than two weeks continuously: Online courses, Online brain training programs
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 |
|---|---|---|
| Digital Program 12/3 of randomized subjects use digital program 1 for 12 weeks to provide mental stimulation | Device | Cohort A, Cohort B |
| Digital Program 21/3 of randomized subjects use digital program 2 for 12 weeks to provide mental stimulation | Device | Cohort A, Cohort B |
Primary outcome
Overall Composite from Creyos (formerly Cambridge Brain Sciences)
Time frame: Study Day 0 to Study Day 84
The Overall Composite is derived from the 12 tests in the Creyos battery.
7 secondary outcomes
Concentration Domain Score from Creyos
Time frame: Study Day 0 to Study Day 84
Memory Domain Score from Creyos
Time frame: Study Day 0 to Study Day 84
Planning Domain Score from Creyos
Time frame: Study Day 0 to Study Day 84
Reasoning Domain Score from Creyos
Time frame: Study Day 0 to Study Day 84
Structural Brain Composite from Magnetic Resonance Imaging (MRI)
Time frame: Study Day 0 to Study Day 84
White Matter Microstructure Composite from Diffusion Magnetic Resonance Imaging (dMRI)
Time frame: Study Day 0 to Study Day 84
Within-Network Functional Connectivity from Resting-State functional Magnetic Resonance Imaging (fMRI)
Time frame: Study Day 0 to Study Day 84
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 15 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results reported in the primary research article and its supplementary information, together with an accompanying data dictionary, will be openly available in a public repository.
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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.
Kevin Madore, 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 Digital Program 1 and Digital Program 2 in people with Cognition and Brain Health, 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 14 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 15 Sep 2026. 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?
Overall Composite from Creyos (formerly Cambridge Brain Sciences) (time frame: Study Day 0 to Study Day 84). 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 15 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.