Alzheimer DiseaseTACADNCT05615233
TACAD Program for Asian American Family Caregivers of Persons Living With Alzheimer's Disease
A study testing TACAD and Alzheimer's Association website in people with Alzheimer Disease, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of the proposed study is to preliminarily evaluate Technology-based information and coaching/support program that is tailored for Asian American midlife women who are family caregivers of patients living with Alzheimer's disease (TACAD) in improving health outcomes of Asian American midlife women who are… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- TACAD and Alzheimer's Association website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2024to 31 Aug 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self reported Asian American midlife women who are family caregivers of persons living with Alzheimer's disease (AACA).
- Participants will be included if, by self-report, they are Asian American women aged 40 to 65 years old who identify as Chinese or Korean;
- are family caregivers of PLAD;
- can read and write English, Mandarin Chinese or Korean;
- who reside in the U.S.;
- have access to the Internet through computers or mobile devices.
- Participants must be providing at least 4 hours per day unpaid assistance, on average, for a community-dwelling person in the early-middle stage of illness (Clinical Dementia Rating of 1) for whom there is no plan for institutionalization in six months.
- Caregivers may or may not reside with their care recipient.
Who cannot join
- Those who used the AA website previously and/or participated in other studies related to AD will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Reduce the Burden of Caregiving on Health Outcomes of Midlife Women: Asian American Family Caregivers of Persons Living With Alzheimer's Disease
The purpose of the proposed study is to preliminarily evaluate Technology-based information and coaching/support program that is tailored for Asian American midlife women who are family caregivers of patients living with Alzheimer's disease (TACAD) in improving health outcomes of Asian American midlife women who are family caregivers of persons living with Alzheimer's disease (AACA) and their care recipients.
Read the detailed description
The purpose of the proposed study is to preliminarily evaluate a technology-based program in improving health outcomes of Asian American midlife women who are family caregivers of persons living with Alzheimer's disease (AACA) and their care recipients.
The participants of this randomized clinical trial will be 60 self-reported AACA aged 40 to 65 years old who identify as Chinese or Korean; are family caregivers of People Living with Alzheimer Disease (PLAD); can read and write English, Mandarin Chinese or Korean; who reside in the U.S.; and have access to the Internet through computers or mobile devices. Participants will be recruited through both online and offline communities/groups for Asian Americans. The recruitment settings are identified through both Internet searches and recommendations by research team members. When potential participants of Phase 2 visit the project Web site (after receiving/reviewing a study announcement), they will be asked to review the informed consent. When participants click I agree to participate, they will have given their consent. No identity information, including IP addresses, will be attached to any of the individual or group data. Therefore, research participants will not be identifiable directly or through the identifying information linked to subjects. Only research staff will have access to the data. Phase 2 study consists of two groups of research participants: (a) a control group who does not use the technology-based program, but uses the information on Alzheimer's Disease and caregiving by the Alzheimer's Association website; (b) an intervention group who uses the technology-based program and the information by the Alzheimer's Association website. Both groups will participate in the study for 3 months. During the research process, both groups are asked to fill out the Internet survey questionnaire (through the REDCap system) at three times (pre-test, post-1 moth, and post 3-months); if requested, paper-and-pencil questionnaires will be provided/used, or research staff will assist in administering the Internet surveys over the phone. Data will be collected only through the Internet survey, and each survey takes about 20 to 30 minutes to complete. Only for the intervention group, weekly group and individual coaching/support (max 1hr/week) by culturally matched bilingual interventionists will be provided through the online forum and chatting functions on the project website, phone calls, or text messages through ethnic-specific communication apps, and the participants are asked to use the educational modules, virtual reality app, and online resources that are available on the project website. The data collected through the Internet surveys will be stored on the HIPAA compliant clouds maintained by The University of Texas at Austin. All documentation related to the study will be also stored on the HIPAA compliant clouds maintained by The University of Texas at Austin.
- Conditions
- Alzheimer Disease
- Being tested
- TACAD, Alzheimer's Association website
- Keywords
- Caregiver
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACADBehavioural
Technology-based information and coaching/support program that is tailored for Asian American midlife women who are family caregivers of PLAD (TACAD). It includes four components in three languages (English, MandarinChinese, and Korean):
- 2 sub-ethnic specific social media sites;
- interactive online educational modules;
- online resources; and
- a VR component based on "A Walk Through Dementia (WTD)"
Alzheimer's Association websiteBehavioural
Also called AA website
The webpage on caregiving includes information on caregiving, care option, financial/legal planning, caregiver health, daily care, stages and behaviors, and safety. The content will be available in the three languages at the project website.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patient will use TACAD and the Alzheimer's Association Website Receives: Behavioral: TACAD; Behavioral: Alzheimer's Association website |
| Active Control Group | Active comparator | Patient will use only the Alzheimer's Association Website Receives: Behavioral: Alzheimer's Association website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Multidimensional Caregiver Strain Index from baseline
Is a questionnaire that evaluates caregiver's health outcome. Total possible score range is 0-26. Higher score correlates with worse outcome.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in Perceived Stress Scale score from baseline
Measure of individual stress. Possible score range is 0-40 with higher scores indicating higher perceived stress.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in Acculturation Stress Scale (ASS) score from baseline
Score range is 0-36. Higher score correlates with worse outcome (higher stress)
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in Social Readjustment Rating Scale (SRRS) score from baseline
This questionnaire asks about number the of events in the last 12 months. Total score range 0-41 and higher score correlates with higher stress.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in Midlife Women's Symptom Index from baseline
This questionnaire measures physical and psychological symptoms during the last 6 months. It includes 73 questions that can be rated from 0-4. Possible score ranges from 0-292. Higher score correlates with worse outcome.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in EQ-5D-5L scale score from baseline
This is a generic health status measure by the EuroQol Group to measure quality of daily life. It includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/ depression) with five responses for each dimension (no problem to extreme problems); each digit in the five-digit codes refers to the status of each dimension, ranging from 1 (no problem) to 5 (severe problem). Possible score ranges from 0 to 100. A higher score in the EQ-5D-5L indicated better health-related Quality of Life.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score from baseline
This questionnaire measures the cognitive status of care recipients. Total possible score ranges from 8-40. Higher score correlates with worse outcome.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in Lawton ADL/IADL Scale score from baseline
This questionnaires measures instrumental activities of daily living. The Lawton IADL scale contains eight items, with a summary score from 0 (low function) to 8 (high function). Possible total score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men. The higher the score, the greater the person's abilities.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in Revised Memory and Behavior Problem Checklist score from baseline
This outcome measures behavioral and psychological symptoms of care recipients. Total possible score ranges between 0-96 with higher score correlating with worse outcome.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in Neuropsychological Inventory Questionnaire score from baseline
This questionnaire measures care recipients' mood status. This is a 12-item inventory assessing severity of mood states or behaviors reflecting mood. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=extreme distress). Total possible score ranges 0 to 144.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in Quality of Life Scale in Alzheimer's Disease score from baseline
This questionnaire assesses quality of life (QOL) in 13 domains on a one 4-point Likert scale. It is used as a self-report and surrogate-report instrument. It uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks. Total possible score ranges 13 to 52.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Secondary outcomes (4)
Change in Caregiver Activity Survey score from baseline
This survey measures the time caregivers spend aiding Alzheimer's patients with their day-to-day activities. The instrument includes 6 areas of caregiving activities (communicating with the person, using transportation, dressing, eating, looking after one's appearance, and supervising the person). Each items score reflects how many minutes is spent in that activity during the day prior to each assessment, and total scores are calculated in hours. Total possible score ranges from 0 to 24 hours. Higher scores indicate greater caregiver distress.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in Ways of Coping Scale score from baseline
This scale measures caregivers' coping status. It is a 42-item scale with 4-point Likert responses that identifies emotion- and problem-focused coping responses of caregivers. Possible score range is 0-198. Higher score correlates with better outcome.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in Pearlin Mastery, Loss, and Competence Scale score from baseline
This scale measures the extent to which an individual regards their life chances as being under their personal control rather than fatalistically ruled. Individual items use a 4-point Likert scale (1,"Strongly disagree" and 4,"Strongly agree"). Possible total score ranges 7 to 28. Higher scores indicate greater levels of mastery.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Change in Caregiver Assessment of Behavioral Skill Scale score from baseline
This scale measures caregiving skills. This is a 17-item self-report assessment of behavioral management skills. Each item is measured on a 3-point Likert scale (0 = "seldom true" to 2 = "true most of the time"). Possible total score ranges from 0-34. Higher scores indicates greater behavioral skill.
Measured: Baseline, 1 months post intervention, 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start5 Apr 2024
- Primary completion31 May 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-Ok Im, University of Texas at Austin
- Investigators
- Eun-Ok Im, PhD, MPH, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615233
- Sponsor's protocol ID
- STUDY00004376
- Acronym
- TACAD
- Status last verified
- Sep 2025
- First submitted
- 7 Nov 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final data that will be available through the proposed study will be de-identified and the associated codebook that defines the data will be available for sharing with other researchers. The data will be available for secondary analyses especially by those who wish to investigate the efficacy of the technology-based program in various variables other than our major outcome variables.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Reduce the Burden of Caregiving on Health Outcomes of Midlife Women: Asian American Family Caregivers of Persons Living With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05615233
- Acronym / sponsor ID
- TACAD / STUDY00004376
- Conditions
- Alzheimer Disease
- Keywords
- Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 14 Nov 2022 (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 purpose of the proposed study is to preliminarily evaluate Technology-based information and coaching/support program that is tailored for Asian American midlife women who are family caregivers of patients living with Alzheimer's disease (TACAD) in improving health outcomes of Asian American midlife women who are family caregivers of persons living with Alzheimer's disease (AACA) and their care recipients.
Detailed description
The purpose of the proposed study is to preliminarily evaluate a technology-based program in improving health outcomes of Asian American midlife women who are family caregivers of persons living with Alzheimer's disease (AACA) and their care recipients.
The participants of this randomized clinical trial will be 60 self-reported AACA aged 40 to 65 years old who identify as Chinese or Korean; are family caregivers of People Living with Alzheimer Disease (PLAD); can read and write English, Mandarin Chinese or Korean; who reside in the U.S.; and have access to the Internet through computers or mobile devices. Participants will be recruited through both online and offline communities/groups for Asian Americans. The recruitment settings are identified through both Internet searches and recommendations by research team members. When potential participants of Phase 2 visit the project Web site (after receiving/reviewing a study announcement), they will be asked to review the informed consent. When participants click I agree to participate, they will have given their consent. No identity information, including IP addresses, will be attached to any of the individual or group data. Therefore, research participants will not be identifiable directly or through the identifying information linked to subjects. Only research staff will have access to the data. Phase 2 study consists of two groups of research participants: (a) a control group who does not use the technology-based program, but uses the information on Alzheimer's Disease and caregiving by the Alzheimer's Association website; (b) an intervention group who uses the technology-based program and the information by the Alzheimer's Association website. Both groups will participate in the study for 3 months. During the research process, both groups are asked to fill out the Internet survey questionnaire (through the REDCap system) at three times (pre-test, post-1 moth, and post 3-months); if requested, paper-and-pencil questionnaires will be provided/used, or research staff will assist in administering the Internet surveys over the phone. Data will be collected only through the Internet survey, and each survey takes about 20 to 30 minutes to complete. Only for the intervention group, weekly group and individual coaching/support (max 1hr/week) by culturally matched bilingual interventionists will be provided through the online forum and chatting functions on the project website, phone calls, or text messages through ethnic-specific communication apps, and the participants are asked to use the educational modules, virtual reality app, and online resources that are available on the project website. The data collected through the Internet surveys will be stored on the HIPAA compliant clouds maintained by The University of Texas at Austin. All documentation related to the study will be also stored on the HIPAA compliant clouds maintained by The University of Texas at Austin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: TACAD, Behavioral: Alzheimer's Association websitePatient will use TACAD and the Alzheimer's Association Website |
| Active Control Group | Active comparator | Behavioral: Alzheimer's Association websitePatient will use only the Alzheimer's Association Website |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- self reported Asian American midlife women who are family caregivers of persons living with Alzheimer's disease (AACA).
- Participants will be included if, by self-report, they are Asian American women aged 40 to 65 years old who identify as Chinese or Korean;
- are family caregivers of PLAD;
- can read and write English, Mandarin Chinese or Korean;
- who reside in the U.S.;
Key exclusion criteria (1 listed)
- Those who used the AA website previously and/or participated in other studies related to AD will be excluded.
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 |
|---|---|---|
| TACADTechnology-based information and coaching/support program that is tailored for Asian American midlife women who are family caregivers of PLAD (TACAD). It includes four components in three languages (English, MandarinChinese, and Korean): 1. 2 sub-ethnic specific social media sites; 2. interactive online educational modules; 3. online resources; and 4. a VR component based on "A Walk Through Dementia (WTD)" | Behavioural | Intervention Group |
| Alzheimer's Association websiteAlso: AA websiteThe webpage on caregiving includes information on caregiving, care option, financial/legal planning, caregiver health, daily care, stages and behaviors, and safety. The content will be available in the three languages at the project website. | Behavioural | Active Control Group, Intervention Group |
Primary outcome
Change in Multidimensional Caregiver Strain Index from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
Is a questionnaire that evaluates caregiver's health outcome. Total possible score range is 0-26. Higher score correlates with worse outcome.
Change in Perceived Stress Scale score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
Measure of individual stress. Possible score range is 0-40 with higher scores indicating higher perceived stress.
Change in Acculturation Stress Scale (ASS) score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
Score range is 0-36. Higher score correlates with worse outcome (higher stress)
Change in Social Readjustment Rating Scale (SRRS) score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
This questionnaire asks about number the of events in the last 12 months. Total score range 0-41 and higher score correlates with higher stress.
Change in Midlife Women's Symptom Index from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
This questionnaire measures physical and psychological symptoms during the last 6 months. It includes 73 questions that can be rated from 0-4. Possible score ranges from 0-292. Higher score correlates with worse outcome.
Change in EQ-5D-5L scale score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
This is a generic health status measure by the EuroQol Group to measure quality of daily life. It includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/ depression) with five responses for each dimension (no problem to extreme problems); each digit in the five-digit codes refers to the status of each dimension, ranging from 1 (no problem) to 5 (severe problem). Possible score ranges from 0 to 100. A higher score in the EQ-5D-5L indicated better health-related Quality of Life.
Change in Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
This questionnaire measures the cognitive status of care recipients. Total possible score ranges from 8-40. Higher score correlates with worse outcome.
Change in Lawton ADL/IADL Scale score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
This questionnaires measures instrumental activities of daily living. The Lawton IADL scale contains eight items, with a summary score from 0 (low function) to 8 (high function). Possible total score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men. The higher the score, the greater the person's abilities.
Change in Revised Memory and Behavior Problem Checklist score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
This outcome measures behavioral and psychological symptoms of care recipients. Total possible score ranges between 0-96 with higher score correlating with worse outcome.
Change in Neuropsychological Inventory Questionnaire score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
This questionnaire measures care recipients' mood status. This is a 12-item inventory assessing severity of mood states or behaviors reflecting mood. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=extreme distress). Total possible score ranges 0 to 144.
Change in Quality of Life Scale in Alzheimer's Disease score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
This questionnaire assesses quality of life (QOL) in 13 domains on a one 4-point Likert scale. It is used as a self-report and surrogate-report instrument. It uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks. Total possible score ranges 13 to 52.
4 secondary outcomes
Change in Caregiver Activity Survey score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
Change in Ways of Coping Scale score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
Change in Pearlin Mastery, Loss, and Competence Scale score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
Change in Caregiver Assessment of Behavioral Skill Scale score from baseline
Time frame: Baseline, 1 months post intervention, 3 months post intervention
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 24 Sep 2025.
- Individual participant dataSharing planned: Yes. The final data that will be available through the proposed study will be de-identified and the associated codebook that defines the data will be available for sharing with other researchers. The data will be available for secondary analyses especially by those who wish to investigate the efficacy of the technology-based program in various variables other than our major outcome variables.
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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.
Eun-Ok Im, PhD, MPH principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACAD and Alzheimer's Association website in people with Alzheimer Disease, run by University of Texas at Austin 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 8 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 24 Sep 2025. 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?
Change in Multidimensional Caregiver Strain Index from baseline (time frame: Baseline, 1 months post intervention, 3 months post intervention). The study lists 11 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 24 Sep 2025.