HealthyNCT04869111
The BrainHealth Project
A study testing BrainHealth App-Based Program in people with Healthy, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
The BrainHealth Project is a longitudinal study designed to identify factors associated with brain health and cognitive performance across the lifespan. Participants complete online assessments approximately twice per year to measure changes in cognitive, behavioral, and lifestyle-related domains. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BrainHealth App-Based Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 1 Aug 2038
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking
- Access to an internet connect and device
- Able to read information and hear sounds
Who cannot join
- Diagnosed neurodegenerative disease
- History of stroke, concussion, or brain injury that currently hinders you from functioning at your prior level
- Diagnosed with Autism Spectrum Disorder and not functioning independently
- For an overview of the study and LINK TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Center for BrainHealth at The University of Texas at Dallas
Dallas, Texas, 75235
Erin Venza, MS, 9728833208, brainhealthproject@utdallas.edu
Margaret Chaplin, MA, (972) 883-3347, brainhealthproject@utdallas.edu
About this study
Official title: The BrainHealth Project, a Longitudinal Study in Generally Healthy Adults
The BrainHealth Project is a longitudinal study designed to identify factors associated with brain health and cognitive performance across the lifespan. Participants complete online assessments approximately twice per year to measure changes in cognitive, behavioral, and lifestyle-related domains.
Between assessments, participants have access to digital training modules, educational resources, and optional coaching sessions. A subset of participants may be invited to participate in additional components, including neuroimaging.
For an overview of the study and link TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/
Read the detailed description
Description of Study:
The BrainHealth Project is a longitudinal study designed to examine factors associated with brain health, including both maintenance and changes in cognitive function across the lifespan. Additionally, researchers aim to identify more personalized practices for promoting brain health.
The study design is informed by prior longitudinal research, namely the Framingham study, demonstrating the value of large-scale, repeated assessments in identifying modifiable factors associated with health outcomes. The goal of this study is to characterize determinants of brain health and support future research on prevention and intervention strategies.
Participants complete online assessments approximately twice per year to measure changes in cognitive performance and related domains over time. Between assessment time points, participants may engage in digital training modules, educational resources, and optional coaching sessions.
Assessments:
BrainHealth Index (~70 min) - An online battery of cognitive measures and questionnaires. The Clarity section looks at complex thinking capacities such as reasoning, flexibility and strategy. In this section, you will be asked to complete different cognitive tasks. The questionnaires measure other aspects of life that relate to brain health, such as emotional well-being, quality of life, happiness, social support systems, and sleep. In this section, you will rate these aspects of your own life. Participants will also complete a 5 minute assessment with BrainHQ to measure processing speed.
The small group of participants who are invited to complete the brain imaging portion of the study will undergo annual brain imaging and will also complete brain gauge (in-person computer assessment). We will offer participants additional sub-studies, and they will have the opportunity to participate or not.
Additional and Exploratory Assessments:
Participants may be invited to complete additional optional surveys or behavioral tasks administered online to further characterize brain health and related behavioral, lifestyle, and biological domains. These additional assessments are exploratory in nature and are not designated as primary or secondary outcome measures.
Online Trainings, habits, and resources:
Trainings can be accessed through the online dashboard and include videos, exercises, and application opportunities. Trainings include strategies to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize Training will also include strategies for stress management and healthy sleep routines, as well as other brain health education and resources. Most trainings are no more than 10 minutes a day.
Online Coaching:
Online coaching sessions will be offered to participants. Participants can elect to take advantage of this offer to the extent they chose.
For an overview of the study and LINK TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/
- Conditions
- Healthy
- Being tested
- BrainHealth App-Based Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainHealth App-Based ProgramBehavioural
Participants will engage in a BrainHealth app-based program tailored for this study. The program includes ongoing microlearning modules focused on supporting brain health through evidence-informed approaches, such as thinking strategies, cognitive exercises, lifestyle practices, stress management techniques, and other brain-healthy behaviors.
Participants can access educational resources on the broad topic of brain health and can utilize tools to support habit formation. Participants can complete (optional) coaching calls designed to support goal setting, accountability, and application of concepts learned through the program.
| Study group | Role | What they receive |
|---|---|---|
| BrainHealth Intervention Protocol | Experimental | Participants will engage in a BrainHealth app-based program tailored for this study. The program includes ongoing microlearning modules focused on supporting brain health through evidence-informed approaches, such as thinking strategies, cognitive exercises, lifestyle practices, stress management techniques, and other brain-healthy behaviors.
Participants can access educational resources on the broad topic of brain health and can utilize tools to support habit formation. Participants can complete (optional) coaching calls designed to support goal setting, accountability, and application of concepts learned through the program. Receives: Behavioral: BrainHealth App-Based Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
BrainHealth Index (BHI)
Longitudinal change in overall brain health as measured by the BrainHealth Index (BHI), a multidimensional assessment that integrates cognitive performance, social-emotional functioning, well-being, purpose, and lifestyle-related factors. Analyses will evaluate changes in BHI scores (composite and factors) over time. Higher scores indicate better brain health.
Measured: Every 6 months until end of study
Secondary outcomes (2)
Neural and Physiological Markers of Brain Health
For the subset of participants completing in-person study visits, we will measure longitudinal change in neural and physiological markers of brain health, including neuroimaging-derived measures (e.g., cerebral blood flow, functional connectivity, and diffusion metrics) and physiological indicators (e.g., heart rate variability, sleep patterns, and physical activity measured through wearable devices). Relationships between these markers and BrainHealth Index scores will be evaluated over time.
This outcome includes multiple measures with differing scales and interpretations; therefore, the meaning of higher or lower values depends on the specific marker being evaluated.
Measured: baseline, 6 months, then annually until study end
Engagement in Intervention
Participant engagement with study intervention will be measured through training completion, coaching participation, and overall app utilization. Higher values generally indicate greater engagement with the intervention. Associations between engagement metrics and longitudinal changes in brain health outcomes will be evaluated throughout the study.
Measured: From enrollment through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Aug 2020
- Primary completion1 Aug 2038 (estimated)
- Study completion1 Aug 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, University of California, Santa Barbara, University of Kansas Medical Center, Northeastern University, Georgia State University, University of Southern California, NeuroScouting
- Responsible party
- Principal investigator, Sandra Chapman, PhD, The University of Texas at Dallas
- Investigators
- Sandra B Chapman, PhD, Principal investigator, Center for BrainHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869111
- Sponsor's protocol ID
- 23-745
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2021
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chapman SB, Aslan S, Spence JS, Hart JJ Jr, Bartz EK, Didehbani N, Keebler MW, Gardner CM, Strain JF, DeFina LF, Lu H. Neural mechanisms of brain plasticity with complex cognitive training in healthy seniors. Cereb Cortex. 2015 Feb;25(2):396-405. doi: 10.1093/cercor/bht234. Epub 2013 Aug 28.
PubMed 23985135Chapman SB, Fratantoni JM, Robertson IH, D'Esposito M, Ling GSF, Zientz J, Vernon S, Venza E, Cook LG, Tate A, Spence JS. A Novel BrainHealth Index Prototype Improved by Telehealth-Delivered Training During COVID-19. Front Public Health. 2021 Mar 16;9:641754. doi: 10.3389/fpubh.2021.641754. eCollection 2021.
PubMed 33796498Chapman SB, Mudar RA. Enhancement of cognitive and neural functions through complex reasoning training: evidence from normal and clinical populations. Front Syst Neurosci. 2014 Apr 28;8:69. doi: 10.3389/fnsys.2014.00069. eCollection 2014.
PubMed 24808834Chapman SB, Aslan S, Spence JS, Keebler MW, DeFina LF, Didehbani N, Perez AM, Lu H, D'Esposito M. Distinct Brain and Behavioral Benefits from Cognitive vs. Physical Training: A Randomized Trial in Aging Adults. Front Hum Neurosci. 2016 Jul 18;10:338. doi: 10.3389/fnhum.2016.00338. eCollection 2016.
PubMed 27462210Chapman SB, Spence JS, Aslan S, Keebler MW. Enhancing Innovation and Underlying Neural Mechanisms Via Cognitive Training in Healthy Older Adults. Front Aging Neurosci. 2017 Oct 9;9:314. doi: 10.3389/fnagi.2017.00314. eCollection 2017.
PubMed 29062276Motes MA, Yezhuvath US, Aslan S, Spence JS, Rypma B, Chapman SB. Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial. Neurobiol Aging. 2018 Feb;62:72-81. doi: 10.1016/j.neurobiolaging.2017.10.003. Epub 2017 Oct 12.
PubMed 29121545Han K, Davis RA, Chapman SB, Krawczyk DC. Strategy-based reasoning training modulates cortical thickness and resting-state functional connectivity in adults with chronic traumatic brain injury. Brain Behav. 2017 Apr 10;7(5):e00687. doi: 10.1002/brb3.687. eCollection 2017 May.
PubMed 28523229Vas A, Chapman S, Aslan S, Spence J, Keebler M, Rodriguez-Larrain G, Rodgers B, Jantz T, Martinez D, Rakic J, Krawczyk D. Reasoning training in veteran and civilian traumatic brain injury with persistent mild impairment. Neuropsychol Rehabil. 2016 Aug;26(4):502-31. doi: 10.1080/09602011.2015.1044013. Epub 2015 May 27.
PubMed 26018041Das N, Spence JS, Aslan S, Vanneste S, Mudar R, Rackley A, Quiceno M, Chapman SB. Cognitive Training and Transcranial Direct Current Stimulation in Mild Cognitive Impairment: A Randomized Pilot Trial. Front Neurosci. 2019 Apr 12;13:307. doi: 10.3389/fnins.2019.00307. eCollection 2019.
PubMed 31031581Han K, Martinez D, Chapman SB, Krawczyk DC. Neural correlates of reduced depressive symptoms following cognitive training for chronic traumatic brain injury. Hum Brain Mapp. 2018 Jul;39(7):2955-2971. doi: 10.1002/hbm.24052. Epub 2018 Mar 23.
PubMed 29573026Venza EE, Chapman SB, Aslan S, Zientz JE, Tyler DL, Spence JS. Enhancing Executive Function and Neural Health in Bipolar Disorder through Reasoning Training. Front Psychol. 2016 Nov 1;7:1676. doi: 10.3389/fpsyg.2016.01676. eCollection 2016.
PubMed 27847486Gallen CL, Baniqued PL, Chapman SB, Aslan S, Keebler M, Didehbani N, D'Esposito M. Modular Brain Network Organization Predicts Response to Cognitive Training in Older Adults. PLoS One. 2016 Dec 22;11(12):e0169015. doi: 10.1371/journal.pone.0169015. eCollection 2016.
PubMed 28006029Cook LG, Spence JS, Chang Z, Venza EE, Tate A, Robertson IH, D'Esposito M, Ling GSF, Wigginton JG, Chapman SB. Measuring and increasing the brain health span across adulthood: a public health imperative. Sci Rep. 2026 May 2;16(1):20415. doi: 10.1038/s41598-026-51403-3.
PubMed 42069911
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BrainHealth Project, a Longitudinal Study in Generally Healthy Adults
- ClinicalTrials.gov ID
- NCT04869111
- Acronym / sponsor ID
- 23-745
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Collaborators
- University of Iowa, University of California, Santa Barbara, University of Kansas Medical Center, Northeastern University, Georgia State University, University of Southern California, NeuroScouting
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2038 (estimated)
- Study completion
- 1 Aug 2038 (estimated)
- First posted
- 3 May 2021 (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 BrainHealth Project is a longitudinal study designed to identify factors associated with brain health and cognitive performance across the lifespan. Participants complete online assessments approximately twice per year to measure changes in cognitive, behavioral, and lifestyle-related domains.
Between assessments, participants have access to digital training modules, educational resources, and optional coaching sessions. A subset of participants may be invited to participate in additional components, including neuroimaging.
For an overview of the study and link TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/
Detailed description
Description of Study:
The BrainHealth Project is a longitudinal study designed to examine factors associated with brain health, including both maintenance and changes in cognitive function across the lifespan. Additionally, researchers aim to identify more personalized practices for promoting brain health.
The study design is informed by prior longitudinal research, namely the Framingham study, demonstrating the value of large-scale, repeated assessments in identifying modifiable factors associated with health outcomes. The goal of this study is to characterize determinants of brain health and support future research on prevention and intervention strategies.
Participants complete online assessments approximately twice per year to measure changes in cognitive performance and related domains over time. Between assessment time points, participants may engage in digital training modules, educational resources, and optional coaching sessions.
Assessments:
BrainHealth Index (~70 min) - An online battery of cognitive measures and questionnaires. The Clarity section looks at complex thinking capacities such as reasoning, flexibility and strategy. In this section, you will be asked to complete different cognitive tasks. The questionnaires measure other aspects of life that relate to brain health, such as emotional well-being, quality of life, happiness, social support systems, and sleep. In this section, you will rate these aspects of your own life. Participants will also complete a 5 minute assessment with BrainHQ to measure processing speed.
The small group of participants who are invited to complete the brain imaging portion of the study will undergo annual brain imaging and will also complete brain gauge (in-person computer assessment). We will offer participants additional sub-studies, and they will have the opportunity to participate or not.
Additional and Exploratory Assessments:
Participants may be invited to complete additional optional surveys or behavioral tasks administered online to further characterize brain health and related behavioral, lifestyle, and biological domains. These additional assessments are exploratory in nature and are not designated as primary or secondary outcome measures.
Online Trainings, habits, and resources:
Trainings can be accessed through the online dashboard and include videos, exercises, and application opportunities. Trainings include strategies to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize Training will also include strategies for stress management and healthy sleep routines, as well as other brain health education and resources. Most trainings are no more than 10 minutes a day.
Online Coaching:
Online coaching sessions will be offered to participants. Participants can elect to take advantage of this offer to the extent they chose.
For an overview of the study and LINK TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BrainHealth Intervention Protocol | Experimental | Behavioral: BrainHealth App-Based ProgramParticipants will engage in a BrainHealth app-based program tailored for this study. The program includes ongoing microlearning modules focused on supporting brain health through evidence-informed approaches, such as thinking strategies, cognitive exercises, lifestyle practices, stress management techniques, and other brain-healthy behaviors. Participants can access educational resources on the broad topic of brain health and can utilize tools to support habit formation. Participants can complete (optional) coaching calls designed to support goal setting, accountability, and application of concepts learned through the program. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Access to an internet connect and device
- Able to read information and hear sounds
Key exclusion criteria (4 listed)
- Diagnosed neurodegenerative disease
- History of stroke, concussion, or brain injury that currently hinders you from functioning at your prior level
- Diagnosed with Autism Spectrum Disorder and not functioning independently
- For an overview of the study and LINK TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/
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 |
|---|---|---|
| BrainHealth App-Based ProgramParticipants will engage in a BrainHealth app-based program tailored for this study. The program includes ongoing microlearning modules focused on supporting brain health through evidence-informed approaches, such as thinking strategies, cognitive exercises, lifestyle practices, stress management techniques, and other brain-healthy behaviors. Participants can access educational resources on the broad topic of brain health and can utilize tools to support habit formation. Participants can complete (optional) coaching calls designed to support goal setting, accountability, and application of concepts learned through the program. | Behavioural | BrainHealth Intervention Protocol |
Primary outcome
BrainHealth Index (BHI)
Time frame: Every 6 months until end of study
Longitudinal change in overall brain health as measured by the BrainHealth Index (BHI), a multidimensional assessment that integrates cognitive performance, social-emotional functioning, well-being, purpose, and lifestyle-related factors. Analyses will evaluate changes in BHI scores (composite and factors) over time. Higher scores indicate better brain health.
2 secondary outcomes
Neural and Physiological Markers of Brain Health
Time frame: baseline, 6 months, then annually until study end
Engagement in Intervention
Time frame: From enrollment through study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 23985135Chapman SB, Aslan S, Spence JS, Hart JJ Jr, Bartz EK, Didehbani N, Keebler MW, Gardner CM, Strain JF, DeFina LF, Lu H. Neural mechanisms of brain plasticity with complex cognitive training in healthy seniors. Cereb Cortex. 2015 Feb;25(2):396-405. doi: 10.1093/cercor/bht234. Epub 2013 Aug 28.
- Background: PubMed 33796498Chapman SB, Fratantoni JM, Robertson IH, D'Esposito M, Ling GSF, Zientz J, Vernon S, Venza E, Cook LG, Tate A, Spence JS. A Novel BrainHealth Index Prototype Improved by Telehealth-Delivered Training During COVID-19. Front Public Health. 2021 Mar 16;9:641754. doi: 10.3389/fpubh.2021.641754. eCollection 2021.
- Background: PubMed 24808834Chapman SB, Mudar RA. Enhancement of cognitive and neural functions through complex reasoning training: evidence from normal and clinical populations. Front Syst Neurosci. 2014 Apr 28;8:69. doi: 10.3389/fnsys.2014.00069. eCollection 2014.
- Background: PubMed 27462210Chapman SB, Aslan S, Spence JS, Keebler MW, DeFina LF, Didehbani N, Perez AM, Lu H, D'Esposito M. Distinct Brain and Behavioral Benefits from Cognitive vs. Physical Training: A Randomized Trial in Aging Adults. Front Hum Neurosci. 2016 Jul 18;10:338. doi: 10.3389/fnhum.2016.00338. eCollection 2016.
- Background: PubMed 29062276Chapman SB, Spence JS, Aslan S, Keebler MW. Enhancing Innovation and Underlying Neural Mechanisms Via Cognitive Training in Healthy Older Adults. Front Aging Neurosci. 2017 Oct 9;9:314. doi: 10.3389/fnagi.2017.00314. eCollection 2017.
- Background: PubMed 29121545Motes MA, Yezhuvath US, Aslan S, Spence JS, Rypma B, Chapman SB. Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial. Neurobiol Aging. 2018 Feb;62:72-81. doi: 10.1016/j.neurobiolaging.2017.10.003. Epub 2017 Oct 12.
- Background: PubMed 28523229Han K, Davis RA, Chapman SB, Krawczyk DC. Strategy-based reasoning training modulates cortical thickness and resting-state functional connectivity in adults with chronic traumatic brain injury. Brain Behav. 2017 Apr 10;7(5):e00687. doi: 10.1002/brb3.687. eCollection 2017 May.
- Background: PubMed 26018041Vas A, Chapman S, Aslan S, Spence J, Keebler M, Rodriguez-Larrain G, Rodgers B, Jantz T, Martinez D, Rakic J, Krawczyk D. Reasoning training in veteran and civilian traumatic brain injury with persistent mild impairment. Neuropsychol Rehabil. 2016 Aug;26(4):502-31. doi: 10.1080/09602011.2015.1044013. Epub 2015 May 27.
- Background: PubMed 31031581Das N, Spence JS, Aslan S, Vanneste S, Mudar R, Rackley A, Quiceno M, Chapman SB. Cognitive Training and Transcranial Direct Current Stimulation in Mild Cognitive Impairment: A Randomized Pilot Trial. Front Neurosci. 2019 Apr 12;13:307. doi: 10.3389/fnins.2019.00307. eCollection 2019.
- Background: PubMed 29573026Han K, Martinez D, Chapman SB, Krawczyk DC. Neural correlates of reduced depressive symptoms following cognitive training for chronic traumatic brain injury. Hum Brain Mapp. 2018 Jul;39(7):2955-2971. doi: 10.1002/hbm.24052. Epub 2018 Mar 23.
- Background: PubMed 27847486Venza EE, Chapman SB, Aslan S, Zientz JE, Tyler DL, Spence JS. Enhancing Executive Function and Neural Health in Bipolar Disorder through Reasoning Training. Front Psychol. 2016 Nov 1;7:1676. doi: 10.3389/fpsyg.2016.01676. eCollection 2016.
- Background: PubMed 28006029Gallen CL, Baniqued PL, Chapman SB, Aslan S, Keebler M, Didehbani N, D'Esposito M. Modular Brain Network Organization Predicts Response to Cognitive Training in Older Adults. PLoS One. 2016 Dec 22;11(12):e0169015. doi: 10.1371/journal.pone.0169015. eCollection 2016.
- 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.
Sandra B Chapman, PhD principal investigator
Center for BrainHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainHealth App-Based Program in people with Healthy, run by The University of Texas at Dallas 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 3 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: looking for participants now, as of the sponsor's last update on 23 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin C, MS (9728833208, erin.venza@utdallas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BrainHealth Index (BHI) (time frame: Every 6 months until end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04869111, which also lists 13 linked publications.
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 23 Jun 2026.