AgingPhase 2EFTNCT05598047
Executive Functioning Training Study
A Phase 2 study testing Executive Functioning Training in people with Aging and Cognitive Function Abnormal, run by University of Alabama at Birmingham.
Trial summary
Cognitive aging in people with HIV (PWH) is of increasing concern for several reasons: 1) between 52%-59% of PWH experience cognitive impairment known as HIV-Associated Neurocognitive Disorder (HAND) which impacts everyday functioning and quality of life; 2) HAND increases in severity and prevalence with age; and 3)… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Function Abnormal, Cognitive Performance
- What is being tested?
- Executive Functioning Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- No sites listed yet
- Study dates
- 13 Jun 2023to 8 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants (men \& women) must be 40+ years
- English speaking,
- Willing to meet in person
- Has time to participate for ~12 weeks
Who cannot join
- Participants living beyond 60 miles away from the center
- Participants living in unstable housing (e.g., halfway house)
- Participants with significant neuromedical comorbidities (e.g., schizophrenia)
- Participants with other conditions (e.g., legally blind/deaf, currently undergoing radiation or chemotherapy, or a history of significant brain trauma, diagnosed with COVID-19 over the past 3 months) that could impact cognitive functioning or testing.
- Participants who have received cognitive training within the past three years
About this study
Official title: Executive Function Training to Reduce Cognitive Intra-Individual Variability in Adults With HIV
Cognitive aging in people with HIV (PWH) is of increasing concern for several reasons: 1) between 52%-59% of PWH experience cognitive impairment known as HIV-Associated Neurocognitive Disorder (HAND) which impacts everyday functioning and quality of life; 2) HAND increases in severity and prevalence with age; and 3) 70% of PWH in the United States will be 50 and older by 2030. Fortunately, cognitive training programs can individually target specific cognitive impairments in PWH and possibly reduce the severity and prevalence of HAND and improve everyday functioning and quality of life. This approach is based around the underlying concept of intra-individual variability as controlled through higher level allocation of cognitive resources, known as executive functioning. This feasibility study will use a two-group pre-post experimental design of adults with HAND including: 1) a 20-hours of Executive Functioning Training group (enroll 60, n=48 with attrition), and 2) a no-contact control (enroll 60, n=48 with attrition). Aim 1 - Feasibility: To determine feasibility and acceptability of the intervention (i.e., attrition, feedback). Exploratory Aim 1 - Cognition: Compare adults who receive Executive Functioning Training to those who receive no training to determine whether they improve in global cognitive ability and overall cognitive IIV. This high impact study is innovative in the following ways: 1) This is the first study aimed to reduce cognitive IIV in PWH. 2) This is the first study to use IIV as a guide to target solely executive functioning training to improve global cognitive ability, which may reduce the severity and prevalence of HAND. 3) Over the last decade, the epicenter of HIV has emerged in the Deep South where this study will occur. Most participants in this study will be older PWH who identify as lower social economic status (SES) and/or African Americans and experience HAND symptoms.
Read the detailed description
OVERALL -- A pre-post three-group experimental design will be used. Participants will be recruited from the University of Alabama at Birmingham (UAB) 1917 HIV/AIDS Clinic which has a patient population of +3,600 and is the largest HIV medical provider within 100 miles. Eligible participants will be consented at the UAB Center for Research on Applied Gerontology where a ~2 hr baseline assessment will be administered. Participants' neuropsychological data gathered at baseline will be examined to determine a HAND classification. Only participants with HIV-Associated Neurocognitive Disorder (HAND) will be invited to continue with the study. Stratified random assignment will ensure an equal number of participants in each group by gender, minority status, and with/without executive functioning impairment (i.e., 1 standard deviation below normative mean). After training, participants will complete a posttest assessment.
Recruitment/Retention Strategies. As effective in our studies, recruitment/retention strategies will be used. 1) Recruitment materials distributed in the UAB 1917 HIV/AIDS Clinic. 2) Reminder letters and telephone calls will be used before the scheduled visit. 3) Beverages/snacks will be provided (from departmental funds). 5) Secondary contact information will be collected to follow up with lost participants.
Intervention Protocol BrainHQ (POSIT Science Inc.) cognitive training modules will be used as in our other studies; these programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises. The intervention will be administered in the research lab of the UAB Center for Applied Gerontology where many of our other studies have been conducted. Working with BrainHQ, when logging on, participants can only receive the individualized cognitive training exercises they are assigned.
Executive Functioning Training Group. Those in the Executive Functioning Training Group will engage in exercises requiring one to set shift; that is, to maintain at least two sets of rules and decide which is appropriate to determine the response. In using these training exercises in the Training On Purpose Study (TOPS), the effects size was quite large (d=-0.89). Dosage of 20 hours of training is considered an upper range on how much training is needed to produce an optimal therapeutic effect.
No-Contact Control Group. This group will receive no intervention. As this is a pilot/feasibility study, investigators do not have the resources to provide a contact control group. Importantly, in a prior study, investigators established that a no-contact control group and a contact control (sham) group did not significantly differ from each other and both served as an excellent comparison to a cognitive intervention.
Instruments Administration time of the assessment will be ~2 hrs. Investigators will use REDCap and BrainBaseline Assessment of Cognition and Everyday Functioning (BRACE+) tablet for administration of the instruments below to reduce tester burden, tester error, and improve the efficiency of data entry and data management, which will save significant staff time and resources. Other cognitive studies as observed in the HIV Neurobehavioral Research Center (HNRC) group employ testing assessments of similar length. BRACE+ was develop in conjunction with HNRC.
- Conditions
- Aging, Cognitive Function Abnormal, Cognitive Performance, Cognitive Training, Older Adults
- Being tested
- Executive Functioning Training
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive Functioning TrainingBehavioural
Those in the Executive Functioning Training Group will engage in exercises requiring one to set shift; that is, to maintain at least two sets of rules and decide which is appropriate to determine the response. In using these training exercises in the TOPS study, the effects size was quite large (d=-0.89). Dosage of 20 hours of training is considered an upper range on how much training is needed to produce an optimal therapeutic effect.
| Study group | Role | What they receive |
|---|---|---|
| Executive Functioning Training | Experimental | BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises. Receives: Behavioral: Executive Functioning Training |
| No-Contact Control Group | No intervention | These participants will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Perceived Need for Cognitive Training
Participants rated whether they need computerize cognitive training to improve their cognition (scale from 0=not at all to 10=extremely).
Measured: ~12 weeks
Cognitive Training Satisfaction
Participants were asked how much they enjoyed the cognitive training (scale from 1=not at all to 5=extremely).
Measured: ~12 weeks
Cognitive Training Preferences
Investigators administer a qualitative (i.e., open-ended responses) survey to assess what participants liked/disliked (i.e. preferences) about the training and how to improve it. These verbal responses were then coded into categories for those who were assigned to the EFT group.
Measured: ~12 weeks
Hours of Cognitive Training Completed
Investigators calculated the hours of training completed. Ranges will be from 0 to 20 hours (i.e., 0% to 100%).
Measured: From enrollment through completion on average around 12 weeks
Attrition Rates (After Study Data Collection)
Investigators calculated the attrition rate of the protocol as measured by those who completed a posttest assessment; this was the indicator that participants completed the study.
Measured: From enrollment through completion on average around 12 weeks
Secondary outcomes (1)
Cognitive Inconsistency (Cognitive Intra-individual Variability)
Cognitive Inconsistency (a type of cognitive intra-individual variability) was calculated with Variability (measures consistency of participants hit reaction times during the test) and Hit Rate Standard Deviation (measures consistency of response speed). These are measured in T scores; 50 indicates a population mean with a standard deviation of 10. Higher T scores indicate more inconsistency, which is considered a poorer cognitive indicator. There is no clinically relevant threshold.
Measured: ~12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start13 Jun 2023
- Primary completion8 Apr 2025
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pre-post two-group experimental design will be used. One group will receive the experimental executive functioning training and the other group will not receive anything (no-contact control group)
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, David Vance, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598047
- Sponsor's protocol ID
- IRB 300008561
- Other IDs
- 5R21AG077957-02
- Acronym
- EFT
- Status last verified
- Apr 2026
- First submitted
- 13 Oct 2022
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will archive all data electronically without PHI which will be available upon request.
Publications
Vance DE, Fazeli PL, Azuero A, Wadley VG, Raper JL, Ball KK. Can Individualized-Targeted Computerized Cognitive Training Benefit Adults with HIV-Associated Neurocognitive Disorder? The Training on Purpose Study (TOPS). AIDS Behav. 2021 Dec;25(12):3898-3908. doi: 10.1007/s10461-021-03230-y. Epub 2021 Mar 18.
PubMed 33733311Vance DE, Fazeli PL, Cheatwood J, Nicholson C, Morrison S, Moneyham LD. Targeting HIV-Related Neurocognitive Impairments with Cognitive Training Strategies: Insights from the Cognitive Aging Literature. Curr Top Behav Neurosci. 2021;50:503-515. doi: 10.1007/7854_2018_80.
PubMed 30710223Waldrop D, Irwin C, Nicholson WC, Lee CA, Webel A, Fazeli PL, Vance DE. The Intersection of Cognitive Ability and HIV: A Review of the State of the Nursing Science. J Assoc Nurses AIDS Care. 2021 May-Jun 01;32(3):306-321. doi: 10.1097/JNC.0000000000000232.
PubMed 33449578
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Function Training to Reduce Cognitive Intra-Individual Variability in Adults With HIV
- ClinicalTrials.gov ID
- NCT05598047
- Acronym / sponsor ID
- EFT / IRB 300008561
- Conditions
- Aging, Cognitive Function Abnormal, Cognitive Performance, Cognitive Training, Older Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Posted 20 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive aging in people with HIV (PWH) is of increasing concern for several reasons: 1) between 52%-59% of PWH experience cognitive impairment known as HIV-Associated Neurocognitive Disorder (HAND) which impacts everyday functioning and quality of life; 2) HAND increases in severity and prevalence with age; and 3) 70% of PWH in the United States will be 50 and older by 2030. Fortunately, cognitive training programs can individually target specific cognitive impairments in PWH and possibly reduce the severity and prevalence of HAND and improve everyday functioning and quality of life. This approach is based around the underlying concept of intra-individual variability as controlled through higher level allocation of cognitive resources, known as executive functioning. This feasibility study will use a two-group pre-post experimental design of adults with HAND including: 1) a 20-hours of Executive Functioning Training group (enroll 60, n=48 with attrition), and 2) a no-contact control (enroll 60, n=48 with attrition). Aim 1 - Feasibility: To determine feasibility and acceptability of the intervention (i.e., attrition, feedback). Exploratory Aim 1 - Cognition: Compare adults who receive Executive Functioning Training to those who receive no training to determine whether they improve in global cognitive ability and overall cognitive IIV. This high impact study is innovative in the following ways: 1) This is the first study aimed to reduce cognitive IIV in PWH. 2) This is the first study to use IIV as a guide to target solely executive functioning training to improve global cognitive ability, which may reduce the severity and prevalence of HAND. 3) Over the last decade, the epicenter of HIV has emerged in the Deep South where this study will occur. Most participants in this study will be older PWH who identify as lower social economic status (SES) and/or African Americans and experience HAND symptoms.
Detailed description
OVERALL -- A pre-post three-group experimental design will be used. Participants will be recruited from the University of Alabama at Birmingham (UAB) 1917 HIV/AIDS Clinic which has a patient population of +3,600 and is the largest HIV medical provider within 100 miles. Eligible participants will be consented at the UAB Center for Research on Applied Gerontology where a ~2 hr baseline assessment will be administered. Participants' neuropsychological data gathered at baseline will be examined to determine a HAND classification. Only participants with HIV-Associated Neurocognitive Disorder (HAND) will be invited to continue with the study. Stratified random assignment will ensure an equal number of participants in each group by gender, minority status, and with/without executive functioning impairment (i.e., 1 standard deviation below normative mean). After training, participants will complete a posttest assessment.
Recruitment/Retention Strategies. As effective in our studies, recruitment/retention strategies will be used. 1) Recruitment materials distributed in the UAB 1917 HIV/AIDS Clinic. 2) Reminder letters and telephone calls will be used before the scheduled visit. 3) Beverages/snacks will be provided (from departmental funds). 5) Secondary contact information will be collected to follow up with lost participants.
Intervention Protocol BrainHQ (POSIT Science Inc.) cognitive training modules will be used as in our other studies; these programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises. The intervention will be administered in the research lab of the UAB Center for Applied Gerontology where many of our other studies have been conducted. Working with BrainHQ, when logging on, participants can only receive the individualized cognitive training exercises they are assigned.
Executive Functioning Training Group. Those in the Executive Functioning Training Group will engage in exercises requiring one to set shift; that is, to maintain at least two sets of rules and decide which is appropriate to determine the response. In using these training exercises in the Training On Purpose Study (TOPS), the effects size was quite large (d=-0.89). Dosage of 20 hours of training is considered an upper range on how much training is needed to produce an optimal therapeutic effect.
No-Contact Control Group. This group will receive no intervention. As this is a pilot/feasibility study, investigators do not have the resources to provide a contact control group. Importantly, in a prior study, investigators established that a no-contact control group and a contact control (sham) group did not significantly differ from each other and both served as an excellent comparison to a cognitive intervention.
Instruments Administration time of the assessment will be ~2 hrs. Investigators will use REDCap and BrainBaseline Assessment of Cognition and Everyday Functioning (BRACE+) tablet for administration of the instruments below to reduce tester burden, tester error, and improve the efficiency of data entry and data management, which will save significant staff time and resources. Other cognitive studies as observed in the HIV Neurobehavioral Research Center (HNRC) group employ testing assessments of similar length. BRACE+ was develop in conjunction with HNRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pre-post two-group experimental design will be used. One group will receive the experimental executive functioning training and the other group will not receive anything (no-contact control group)
| Arm | Type | Receives |
|---|---|---|
| Executive Functioning Training | Experimental | Behavioral: Executive Functioning TrainingBrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises. |
| No-Contact Control Group | No intervention | –These participants will not receive any intervention. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants (men \& women) must be 40+ years
- English speaking,
- Willing to meet in person
- Has time to participate for ~12 weeks
Key exclusion criteria (5 listed)
- Participants living beyond 60 miles away from the center
- Participants living in unstable housing (e.g., halfway house)
- Participants with significant neuromedical comorbidities (e.g., schizophrenia)
- Participants with other conditions (e.g., legally blind/deaf, currently undergoing radiation or chemotherapy, or a history of significant brain trauma, diagnosed with COVID-19 over the past 3 months) that could impact cognitive functioning or testing.
- Participants who have received cognitive training within the past three years
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 |
|---|---|---|
| Executive Functioning TrainingThose in the Executive Functioning Training Group will engage in exercises requiring one to set shift; that is, to maintain at least two sets of rules and decide which is appropriate to determine the response. In using these training exercises in the TOPS study, the effects size was quite large (d=-0.89). Dosage of 20 hours of training is considered an upper range on how much training is needed to produce an optimal therapeutic effect. | Behavioural | Executive Functioning Training |
Primary outcome
Self-Perceived Need for Cognitive Training
Time frame: ~12 weeks
Participants rated whether they need computerize cognitive training to improve their cognition (scale from 0=not at all to 10=extremely).
Cognitive Training Satisfaction
Time frame: ~12 weeks
Participants were asked how much they enjoyed the cognitive training (scale from 1=not at all to 5=extremely).
Cognitive Training Preferences
Time frame: ~12 weeks
Investigators administer a qualitative (i.e., open-ended responses) survey to assess what participants liked/disliked (i.e. preferences) about the training and how to improve it. These verbal responses were then coded into categories for those who were assigned to the EFT group.
Hours of Cognitive Training Completed
Time frame: From enrollment through completion on average around 12 weeks
Investigators calculated the hours of training completed. Ranges will be from 0 to 20 hours (i.e., 0% to 100%).
Attrition Rates (After Study Data Collection)
Time frame: From enrollment through completion on average around 12 weeks
Investigators calculated the attrition rate of the protocol as measured by those who completed a posttest assessment; this was the indicator that participants completed the study.
1 secondary outcome
Cognitive Inconsistency (Cognitive Intra-individual Variability)
Time frame: ~12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33733311Vance DE, Fazeli PL, Azuero A, Wadley VG, Raper JL, Ball KK. Can Individualized-Targeted Computerized Cognitive Training Benefit Adults with HIV-Associated Neurocognitive Disorder? The Training on Purpose Study (TOPS). AIDS Behav. 2021 Dec;25(12):3898-3908. doi: 10.1007/s10461-021-03230-y. Epub 2021 Mar 18.
- Background: PubMed 30710223Vance DE, Fazeli PL, Cheatwood J, Nicholson C, Morrison S, Moneyham LD. Targeting HIV-Related Neurocognitive Impairments with Cognitive Training Strategies: Insights from the Cognitive Aging Literature. Curr Top Behav Neurosci. 2021;50:503-515. doi: 10.1007/7854_2018_80.
- Background: PubMed 33449578Waldrop D, Irwin C, Nicholson WC, Lee CA, Webel A, Fazeli PL, Vance DE. The Intersection of Cognitive Ability and HIV: A Review of the State of the Nursing Science. J Assoc Nurses AIDS Care. 2021 May-Jun 01;32(3):306-321. doi: 10.1097/JNC.0000000000000232.
- Individual participant dataSharing planned: Yes. We will archive all data electronically without PHI which will be available upon request.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Executive Functioning Training in people with Aging and Cognitive Function Abnormal, run by University of Alabama at Birmingham.
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 5 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-Perceived Need for Cognitive Training (time frame: ~12 weeks). The study lists 5 primary outcomes in all. 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 NCT05598047, which also lists 3 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 20 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.