Dementia, VascularNCT05516342
LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
A study testing LEAD IT! Programming in people with Dementia, Vascular and Alzheimer Disease, run by Hopeful Aging at 1 site in United States.
Trial summary
The proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, which is a tablet-based app designed to enable persons with dementia to lead activities for their peers (i.e., other persons with dementia). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Vascular, Alzheimer Disease, Dementia, Mixed
- What is being tested?
- LEAD IT! Programming
- 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
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2020to 11 Jun 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must reside in an Assisted Living Facility or NH
- Must be at least 65 years old
- Must speak and read English
- Must have a clinical diagnosis of dementia (any type).
- Resident-players must score at least five on the Mini-Mental State Examination (MMSE)
- Resident-leaders must score at least 13 on the MMSE
Show all 10Show fewer
- Resident-leaders must possess at least 70% of the characteristics of successful leaders, based upon the I'm Still Here Skills Inventory, Short Edition, Modified
- Exclusion Criteria for Persons with Dementia -the person shows signs of rapid cognitive decline or physical deterioration over the last six months, as evidenced by medical records.
- Must be at least 18 years old
- Must speak English
Who cannot join
- -n/a
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hearthstone Institute, LLC
Winchester, Massachusetts, 01890
About this study
The proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, which is a tablet-based app designed to enable persons with dementia to lead activities for their peers (i.e., other persons with dementia). The study will examine the clinical outcomes of long-term use of the app by both Resident Leaders (RLs) and Resident Players (RPs).
The Specific Aims of the proposed Phase 2 project are to:
- Develop improved Beta 1 and Beta 2 Versions of LEAD IT! with sufficient content to facilitate six activities twice per week for 4.5 months.
- Examine the extent to which RLs are able to serve as leaders while using LEAD IT!
- Examine the effects of resident-led LEAD IT! programming on RPs.
- Examine PWD and staff satisfaction with LEAD IT!
Read the detailed description
he proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, as well as examine the clinical outcomes of long-term use of the app by both RLs and RPs.
The Specific Aims of the proposed Phase 2 project are to:
- Develop improved Beta 1 and Beta 2 Versions of LEAD IT! with sufficient content to facilitate six activities twice per week for 4.5 months. During Months 1-7, the Beta 1 version of the app will be created by the study's Development Team (DT). During Months 13-15, the DT will create an improved Beta 2 version, based on lessons learned in Beta 1 testing.
- Examine the extent to which RLs are able to serve as leaders while using LEAD IT! During all intervention sessions, researchers will track the extent to which each RL follows key steps involved in leading each activity. RLs will be considered successful if they follow the steps 80% of the time and require less staff assistance on less than 20% of steps.
- Examine the effects of resident-led LEAD IT! programming on RPs. Two quasi-experiments will be conducted. Experiment #1, which will test the Beta 1 version of LEAD IT!, will use a pre-post design. Proximal (immediate) effects will be assessed by examining RP's levels of engagement/affect during baseline (standard) activities and again during LEAD IT! activities. It is hypothesized that LEAD IT! will result in higher quality engagement than baseline activities. Experiment #2, which will test the Beta 2 version of the app, will be a cluster randomized trial (CRT), consisting of pre- and post-intervention measurements of a Treatment Group (TG)-which will consist of PWD who receive the intervention - and a Control Group (CG) - which will consist of PWD who receive standard programming / care. Since Experiment #2 will occur after all improvements to the app have been made, it will represent the definitive trial of the LEAD IT! app's impact on PWD. For proximal (immediate) measures, it is anticipated that there will be a Group x Time interaction effect, with TG participants exhibiting significantly greater increases in positive forms of engagement, as compared to CG participants. For distal measures, it is anticipated that there will be a Group x Time interaction effect, with TG participants exhibiting significantly greater increases in quality of life (based upon the DEMQOL) at treatment, as compared to CG participants.
- Examine PWD and staff satisfaction with LEAD IT! This will be achieved by eliciting feedback from PWD and staff members. PWD and staff members will be considered "highly satisfied" with the app if 85% are satisfied with the app.
- Conditions
- Dementia, Vascular, Alzheimer Disease, Dementia, Mixed
- Being tested
- LEAD IT! Programming
- Keywords
- psychosocial, social, non-pharmacological intervention
- Medical subject headings
- Dementia, Vascular, Alzheimer Disease, Mixed Dementias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEAD IT! ProgrammingBehavioural
LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental, LEAD IT! Programming | Experimental | Participants in the Experimental / LEAD IT! arm will take part in LEAD IT! programming for 18 weeks. The programming will occur twice per week, for a total of 36 sessions. Receives: Behavioral: LEAD IT! Programming |
| No Intervention: Control, Standard Care / Programming | No intervention | Participants in the Control arm will receive standard care / programming. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale [Time Frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Constructive Engagement on the Menorah Park Engagement Scale is defined as doing or commenting on something related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome.
Measured: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale
Passive Engagement on the Menorah Park Engagement Scale is defined as listening or watching something related to the target activity.During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome..
Measured: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale
Other Engagement on the Menorah Park Engagement Scale is defined as doing, commenting, listening, or watching something NOT related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Other Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Measured: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Change From Baseline to Treatment for Non Engagement on the Menorah Park Engagement Scale
Non-Engagement on the Menorah Park Engagement Scale is defined as sleeping and/or staring into space. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Non-Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Measured: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale
Pleasure on the Menorah Park Engagement Scale is defined as clearly observable laughing or smiling. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Pleasure is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Measured: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Secondary outcomes (4)
Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)
The Dementia Related Quality of Life Scale is a 28 item scale that examines quality of life in persons with dementia. The score ranges for 28 to 112. Higher scores represent a better outcome.
Measured: Baseline (Month 1) and Post-Treatment (Month 4)
Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)
The NPI-NH examines 10 types of neuropsychiatric symptoms in persons with dementia, with the FxS score looking creating a composite score that takes into account frequency and severity of the symptoms. The score ranges from 0 to 120. Lower scores represent a better outcome.
Measured: Baseline (Month 1) and Post-Treatment (Month 4)
Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)
The GDS-SF consists of 15 questions requiring "yes" or "no" answers. It is specifically developed for use with older adults. For persons unable to answer the questions, a proxy can be used. The total score ranges from 0 to 15, with lower scores indicating a better outcome.
Measured: Baseline (Month 1) and Post-Treatment (Month 4)
Change From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI)
The 14-item CMAI is a caregiver rated questionnaire using a 5-point Likert scale to rate the frequency of disturbing behaviors in dementia such as verbal/physical aggression, general restlessness, strange noises, and so on. Scores range from 14 to 70, with lower scores indicating a better outcome.
Measured: Baseline (Month 1) and Post-Treatment (Month 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start10 Nov 2020
- Primary completion11 Jun 2023
- Study completion11 Jun 2023
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.
- Other trials for Dementia, VascularStudies 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
- Model description
- Two quasi-experiments will be conducted. Experiment #1 will test the Beta 1 Version of the app with 24 PWD and use a pre-post design. Experiment #1's goal is to examine and improve new activities and to make final changes to the overall app structure. Experiment #2, which will test Beta 2, will be a cluster randomized trial (CRT), consisting of pre- and post-intervention measurements of two nonequivalent groups: a Treatment Group (TG)-i.e. 48 PWD who receive the intervention - and a Control Group (CG)- i.e., 48 PWD receiving standard programming / care. Since Experiment #2 will occur after all tweaking is complete, it will represent the definitive trial of LEAD IT!'s proximal and distal effects.
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopeful Aging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Skrajner, MA, Principal investigator, Hearthstone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516342
- Sponsor's protocol ID
- AG059443
- Status last verified
- May 2024
- First submitted
- 10 Aug 2022
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
- ClinicalTrials.gov ID
- NCT05516342
- Acronym / sponsor ID
- AG059443
- Conditions
- Dementia, Vascular, Alzheimer Disease, Dementia, Mixed
- Keywords
- psychosocial, social, non-pharmacological intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Hopeful AgingIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 11 Jun 2023 (actual)
- Study completion
- 11 Jun 2023 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Posted 2 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, which is a tablet-based app designed to enable persons with dementia to lead activities for their peers (i.e., other persons with dementia). The study will examine the clinical outcomes of long-term use of the app by both Resident Leaders (RLs) and Resident Players (RPs).
The Specific Aims of the proposed Phase 2 project are to:
- Develop improved Beta 1 and Beta 2 Versions of LEAD IT! with sufficient content to facilitate six activities twice per week for 4.5 months.
- Examine the extent to which RLs are able to serve as leaders while using LEAD IT!
- Examine the effects of resident-led LEAD IT! programming on RPs.
- Examine PWD and staff satisfaction with LEAD IT!
Detailed description
he proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, as well as examine the clinical outcomes of long-term use of the app by both RLs and RPs.
The Specific Aims of the proposed Phase 2 project are to:
- Develop improved Beta 1 and Beta 2 Versions of LEAD IT! with sufficient content to facilitate six activities twice per week for 4.5 months. During Months 1-7, the Beta 1 version of the app will be created by the study's Development Team (DT). During Months 13-15, the DT will create an improved Beta 2 version, based on lessons learned in Beta 1 testing.
- Examine the extent to which RLs are able to serve as leaders while using LEAD IT! During all intervention sessions, researchers will track the extent to which each RL follows key steps involved in leading each activity. RLs will be considered successful if they follow the steps 80% of the time and require less staff assistance on less than 20% of steps.
- Examine the effects of resident-led LEAD IT! programming on RPs. Two quasi-experiments will be conducted. Experiment #1, which will test the Beta 1 version of LEAD IT!, will use a pre-post design. Proximal (immediate) effects will be assessed by examining RP's levels of engagement/affect during baseline (standard) activities and again during LEAD IT! activities. It is hypothesized that LEAD IT! will result in higher quality engagement than baseline activities. Experiment #2, which will test the Beta 2 version of the app, will be a cluster randomized trial (CRT), consisting of pre- and post-intervention measurements of a Treatment Group (TG)-which will consist of PWD who receive the intervention - and a Control Group (CG) - which will consist of PWD who receive standard programming / care. Since Experiment #2 will occur after all improvements to the app have been made, it will represent the definitive trial of the LEAD IT! app's impact on PWD. For proximal (immediate) measures, it is anticipated that there will be a Group x Time interaction effect, with TG participants exhibiting significantly greater increases in positive forms of engagement, as compared to CG participants. For distal measures, it is anticipated that there will be a Group x Time interaction effect, with TG participants exhibiting significantly greater increases in quality of life (based upon the DEMQOL) at treatment, as compared to CG participants.
- Examine PWD and staff satisfaction with LEAD IT! This will be achieved by eliciting feedback from PWD and staff members. PWD and staff members will be considered "highly satisfied" with the app if 85% are satisfied with the app.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two quasi-experiments will be conducted. Experiment #1 will test the Beta 1 Version of the app with 24 PWD and use a pre-post design. Experiment #1's goal is to examine and improve new activities and to make final changes to the overall app structure. Experiment #2, which will test Beta 2, will be a cluster randomized trial (CRT), consisting of pre- and post-intervention measurements of two nonequivalent groups: a Treatment Group (TG)-i.e. 48 PWD who receive the intervention - and a Control Group (CG)- i.e., 48 PWD receiving standard programming / care. Since Experiment #2 will occur after all tweaking is complete, it will represent the definitive trial of LEAD IT!'s proximal and distal effects.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental, LEAD IT! Programming | Experimental | Behavioral: LEAD IT! ProgrammingParticipants in the Experimental / LEAD IT! arm will take part in LEAD IT! programming for 18 weeks. The programming will occur twice per week, for a total of 36 sessions. |
| No Intervention: Control, Standard Care / Programming | No intervention | –Participants in the Control arm will receive standard care / programming. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must reside in an Assisted Living Facility or NH
- Must be at least 65 years old
- Must speak and read English
- Must have a clinical diagnosis of dementia (any type).
- Resident-players must score at least five on the Mini-Mental State Examination (MMSE)
Key exclusion criteria (1 listed)
- -n/a
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 |
|---|---|---|
| LEAD IT! ProgrammingLEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets. | Behavioural | Experimental: Experimental, LEAD IT! Programming |
Primary outcome
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale [Time Frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Constructive Engagement on the Menorah Park Engagement Scale is defined as doing or commenting on something related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome.
Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale
Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Passive Engagement on the Menorah Park Engagement Scale is defined as listening or watching something related to the target activity.During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome..
Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale
Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Other Engagement on the Menorah Park Engagement Scale is defined as doing, commenting, listening, or watching something NOT related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Other Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Change From Baseline to Treatment for Non Engagement on the Menorah Park Engagement Scale
Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Non-Engagement on the Menorah Park Engagement Scale is defined as sleeping and/or staring into space. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Non-Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale
Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Pleasure on the Menorah Park Engagement Scale is defined as clearly observable laughing or smiling. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Pleasure is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
4 secondary outcomes
Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)
Time frame: Baseline (Month 1) and Post-Treatment (Month 4)
Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)
Time frame: Baseline (Month 1) and Post-Treatment (Month 4)
Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)
Time frame: Baseline (Month 1) and Post-Treatment (Month 4)
Change From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI)
Time frame: Baseline (Month 1) and Post-Treatment (Month 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Michael Skrajner, MA principal investigator
Hearthstone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEAD IT! Programming in people with Dementia, Vascular and Alzheimer Disease, run by Hopeful Aging 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 10 inclusion and 1 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 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2024). 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?
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale [Time Frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4) (time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)). 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?
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 Dec 2024.