DementiaNCT05669365
The Care Ecosystem Consortium Effectiveness Study
A study testing Care Ecosystem in people with Dementia and Dementia, Vascular, run by University of California, San Francisco at 6 sites in United States.
Trial summary
The Care Ecosystem is an accessible, remotely delivered team-based dementia care model, designed to add value for patients, providers and payers in complex organizational and reimbursement structures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Dementia, Vascular, Dementia With Lewy Bodies
- What is being tested?
- Care Ecosystem
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,227 participants
- Where
- 6 sitesUnited States
- Study dates
- 17 Jan 2023to 15 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- Provision of verbal consent (or surrogate consent), documented in REDCap, and assent
- Willingness to enroll in the Care Ecosystem program
- Lives in the community (i.e., not in an assisted living, board \& care, skilled nursing or memory care facility) at the time of enrollment
- Have a dementia diagnosis documented in the EHR
- Has had a visit with the referring provider in the last 12 months
Show all 11Show fewer
- Has a caregiver with a primary level of responsibility for the patient who is eligible and willing to participate
- Age 18+
- Provision of verbal consent, documented in REDCap
- Has a primary level of responsibility for the care of a PWD-participant who is enrolling in the study
- Willingness to enroll in the Care Ecosystem program and complete surveys
Who cannot join
- PWD-participants for whom a substantial amount of the patient's healthcare utilization records cannot be accessed for research purposes by the study team. (see Note)
- Is currently, or was ever enrolled, in the Care Ecosystem program.
- Medical documentation indicates that the patient's dementia is a non-progressive type (e.g., due to a head injury or stroke, and not expected to progress).
- Note: This exclusion criteria will be operationalized differently at each site based on variations in data access options for their patient population; these options will include EHR and Medicare. A small percentage of participants may be enrolled from underrepresented populations for whom a substantial amount of utilization records cannot be accessed with written approval from the study PI. All participants must be affiliated with one of the 6 participating health systems:
- Ochsner Health System Providence Health \& Services Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center HealthPartners Institute University of Colorado, Denver University of California, San Francisco
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Health
Denver, Colorado, 80209
Ochsner Medical Center
New Orleans, Louisiana, 70121
Providence Health
Portland, Oregon, 97213
HealthPartners
Saint Paul, Minnesota, 55130
University of California, San Francisco
San Francisco, California, 94158
LA County Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
The Care Ecosystem is an accessible, remotely delivered team-based dementia care model, designed to add value for patients, providers and payers in complex organizational and reimbursement structures. Care is delivered via the phone and web by unlicensed Care Team Navigators, who are trained and supervised by a team of dementia specialists with nursing, social work, and pharmacy expertise. The evidence base to date suggests that the Care Ecosystem improves outcomes important to people with dementia, caregivers, and payers when delivered in a controlled research environment, including reduced emergency department visits, higher quality of life for patients, lower caregiver depression, and reduced potentially inappropriate medication use (Possin et al., 2019; Liu et al., 2022). The investigators propose a rapid pragmatic trial in 6 health systems currently offering the Care Ecosystem program in geographically and culturally diverse populations. The investigators will leverage technology, delivering care via the phone and web and using electronic health records to monitor quality improvements and evaluate outcomes while maximizing external validity. The investigators will evaluate the effectiveness of the Care Ecosystem on outcomes important to patients, caregivers, healthcare providers, and health systems during the pandemic. By evaluating the real-world effectiveness in diverse health systems that are already providing this model of care, this project will bridge the science-practice gap in dementia care during an unprecedented time of heightened strain on family caregivers, healthcare providers and health systems.
Read the detailed description
This study is a rapid, pragmatic, single-arm trial of 1,275 patients with dementia (PWD) and their caregivers (Total N = 2,550) at 6 US health systems currently offering the Care Ecosystem (CE) intervention to geographically and culturally diverse populations. The investigators will compare the effectiveness of 12-months of the CE intervention with a matched comparison group (N=1,275) identified from the EHR at each site. Patient health care utilization outcomes will be collected via patient insurance / Medicare claims and electronic health record data. Caregiver surveys completed via interview (phone, video or in-person) at baseline, 6-months and 12-months will serve the dual purpose of providing outcome data and supporting care.
This clinical trial is made up of four sub-studies on care quality, utilization, medications, and caregiver and patient experience. While all the sub-studies concern the same intervention group of dyads, each will use data from different sources, different analytic methods, and different controls. Care quality, utilization, and medication metrics will be compared to matched controls identified from the EHR. Caregiver and patient experience metrics will be compared pre/post and to controls from a prior Randomized Control Trial (RCT) (ClinicalTrials.gov NCT02213458). For these reasons, there are primary and secondary endpoints for each.
- Conditions
- Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia Alzheimers, Frontotemporal Dementia
- Being tested
- Care Ecosystem
- Medical subject headings
- Dementia, Dementia, Vascular, Lewy Body Disease, Alzheimer Disease, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care EcosystemBehavioural
Applying the principles of person-and-family centered and collaborative care to dementia, the Care Ecosystem (CE) offers proactive, protocol-guided phone- and web-based caregiver support, guidance, and care coordination that extends the reach of dementia primary and specialty care. Care is delivered primarily via the phone and web by unlicensed Care Team Navigators (CTNs), who are trained and supervised by a team of dementia specialists with nursing, social work, and pharmacy expertise. Care Protocols guide proactive, quality care that is documented in the electronic health record (EHR).
The CTN is an unlicensed, trained dementia care guide who served as the PWD's and caregiver's primary point of contact to the program under nurse supervision. Care team navigators respond to caregivers' immediate needs first, then screen for common problems and provide personalized support and standardized education using the care plan protocols.
| Study group | Role | What they receive |
|---|---|---|
| Care Ecosystem | Experimental | Patient and caregiver dyads receive the Care Ecosystem intervention Receives: Behavioral: Care Ecosystem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia Management Quality Measurement Set
The rate of completion of a 10-item, adapted Dementia Management Quality Measurement Set. This count variable has a range of 0 (no dementia quality care elements completed) to 10 (all dementia quality care elements completed).
Measured: Baseline to 12 months
Change in emergency department (ED) visits
Number of PWD ED visits, using claims and EHRs.
Measured: Baseline to 12 months
Change in potentially inappropriate medications for dementia or cognitive impairment
Number of high-risk medications used, operationalized using the 2019 Beers criteria, using medication lists from the EHR.
Measured: Baseline to 12 months
Change in caregiver depression
Caregiver depression will be measured by the 9-item Patient Health Questionnaire (PHQ-9), ranging from 0-27 points, with higher scores indicating more severe depression.
Measured: Baseline to 12 months
Secondary outcomes (6)
Change in PWD hospitalizations
Number of PWD hospitalizations, using claims and EHRs.
Measured: Baseline to 12 months
Change in PWD annual bed days
Number of PWD inpatient bed days, using claims and EHRs.
Measured: Baseline to 12 months
Change in central nervous system (CNS) acting medications
Number of CNS acting medications to be avoided in persons with dementia, delirium, or a history of falls or fractures according to the 2019 Beers criteria, using medication lists from the EHR.
Measured: Baseline to 12 months
Change in caregiver burden
The Dementia Burden Scale-Caregiver (DBS-CG) is a composite of the Neuropsychiatric Inventory (NPI-Q) for Distress, the Modified Caregiver Strain Index (MCSI), and and 8-item Patient Health Questionnaire (PHQ-8) with items transformed linearly to be on a 0-100 possible range and then averaged with higher scores indicating higher caregiver burden (Peipert et al., 2018).
Measured: Baseline to 12 months
Change in caregiver self-efficacy
Caregiver self-efficacy score, as measured by a four-item survey with scores ranging from 5-20 points and higher scores indicating higher self-efficacy (Possin et al., 2019; Merrilees et al., 2018).
Measured: Baseline to 12 months
Change in caregiver anxiety
Caregiver anxiety score, as measured by the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), with scores ranging from 0-6 and higher scores indicating higher anxiety.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start17 Jan 2023
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Ochsner Health System, Providence Health & Services, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, HealthPartners Institute, University of Colorado, Denver, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Katherine L Possin, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669365
- Sponsor's protocol ID
- 1R01AG074710
- Other IDs
- 1R01AG074710
- Status last verified
- Aug 2025
- First submitted
- 19 Dec 2022
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will submit resource requests for archived data through a Qualtrics-based form, which will include a signed "Data Use Agreement". These will be reviewed monthly by the investigators. If a request is approved, the study staff will review the requested dataset to ensure it is de-identified and encrypted for transfer, along with a data dictionary.
Publications
Peipert JD, Jennings LA, Hays RD, Wenger NS, Keeler E, Reuben DB. A Composite Measure of Caregiver Burden in Dementia: The Dementia Burden Scale-Caregiver. J Am Geriatr Soc. 2018 Sep;66(9):1785-1789. doi: 10.1111/jgs.15502. Epub 2018 Aug 10.
PubMed 30094817Possin KL, Merrilees JJ, Dulaney S, Bonasera SJ, Chiong W, Lee K, Hooper SM, Allen IE, Braley T, Bernstein A, Rosa TD, Harrison K, Begert-Hellings H, Kornak J, Kahn JG, Naasan G, Lanata S, Clark AM, Chodos A, Gearhart R, Ritchie C, Miller BL. Effect of Collaborative Dementia Care via Telephone and Internet on Quality of Life, Caregiver Well-being, and Health Care Use: The Care Ecosystem Randomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1658-1667. doi: 10.1001/jamainternmed.2019.4101.
PubMed 31566651Merrilees JJ, Bernstein A, Dulaney S, Heunis J, Walker R, Rah E, Choi J, Gawlas K, Carroll S, Ong P, Feuer J, Braley T, Clark AM, Lee K, Chiong W, Bonasera SJ, Miller BL, Possin KL. The Care Ecosystem: Promoting self-efficacy among dementia family caregivers. Dementia (London). 2020 Aug;19(6):1955-1973. doi: 10.1177/1471301218814121. Epub 2018 Nov 29.
PubMed 30497302Liu AK, Possin KL, Cook KM, Lynch S, Dulaney S, Merrilees JJ, Braley T, Kiekhofer RE, Bonasera SJ, Allen IE, Chiong W, Clark AM, Feuer J, Ewalt J, Guterman EL, Gearhart R, Miller BL, Lee KP. Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. Alzheimers Dement. 2023 May;19(5):1865-1875. doi: 10.1002/alz.12808. Epub 2022 Nov 4.
PubMed 36331050
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Care Ecosystem Consortium Effectiveness Study
- ClinicalTrials.gov ID
- NCT05669365
- Acronym / sponsor ID
- 1R01AG074710
- Conditions
- Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia Alzheimers, Frontotemporal Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,227 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Ochsner Health System, Providence Health & Services, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, HealthPartners Institute, University of Colorado, Denver, National Institute on Aging (NIA)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 30 Dec 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 Care Ecosystem is an accessible, remotely delivered team-based dementia care model, designed to add value for patients, providers and payers in complex organizational and reimbursement structures. Care is delivered via the phone and web by unlicensed Care Team Navigators, who are trained and supervised by a team of dementia specialists with nursing, social work, and pharmacy expertise. The evidence base to date suggests that the Care Ecosystem improves outcomes important to people with dementia, caregivers, and payers when delivered in a controlled research environment, including reduced emergency department visits, higher quality of life for patients, lower caregiver depression, and reduced potentially inappropriate medication use (Possin et al., 2019; Liu et al., 2022). The investigators propose a rapid pragmatic trial in 6 health systems currently offering the Care Ecosystem program in geographically and culturally diverse populations. The investigators will leverage technology, delivering care via the phone and web and using electronic health records to monitor quality improvements and evaluate outcomes while maximizing external validity. The investigators will evaluate the effectiveness of the Care Ecosystem on outcomes important to patients, caregivers, healthcare providers, and health systems during the pandemic. By evaluating the real-world effectiveness in diverse health systems that are already providing this model of care, this project will bridge the science-practice gap in dementia care during an unprecedented time of heightened strain on family caregivers, healthcare providers and health systems.
Detailed description
This study is a rapid, pragmatic, single-arm trial of 1,275 patients with dementia (PWD) and their caregivers (Total N = 2,550) at 6 US health systems currently offering the Care Ecosystem (CE) intervention to geographically and culturally diverse populations. The investigators will compare the effectiveness of 12-months of the CE intervention with a matched comparison group (N=1,275) identified from the EHR at each site. Patient health care utilization outcomes will be collected via patient insurance / Medicare claims and electronic health record data. Caregiver surveys completed via interview (phone, video or in-person) at baseline, 6-months and 12-months will serve the dual purpose of providing outcome data and supporting care.
This clinical trial is made up of four sub-studies on care quality, utilization, medications, and caregiver and patient experience. While all the sub-studies concern the same intervention group of dyads, each will use data from different sources, different analytic methods, and different controls. Care quality, utilization, and medication metrics will be compared to matched controls identified from the EHR. Caregiver and patient experience metrics will be compared pre/post and to controls from a prior Randomized Control Trial (RCT) (ClinicalTrials.gov NCT02213458). For these reasons, there are primary and secondary endpoints for each.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Care Ecosystem | Experimental | Behavioral: Care EcosystemPatient and caregiver dyads receive the Care Ecosystem intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18+
- Provision of verbal consent (or surrogate consent), documented in REDCap, and assent
- Willingness to enroll in the Care Ecosystem program
- Lives in the community (i.e., not in an assisted living, board \& care, skilled nursing or memory care facility) at the time of enrollment
- Have a dementia diagnosis documented in the EHR
Key exclusion criteria (5 listed)
- PWD-participants for whom a substantial amount of the patient's healthcare utilization records cannot be accessed for research purposes by the study team. (see Note)
- Is currently, or was ever enrolled, in the Care Ecosystem program.
- Medical documentation indicates that the patient's dementia is a non-progressive type (e.g., due to a head injury or stroke, and not expected to progress).
- Note: This exclusion criteria will be operationalized differently at each site based on variations in data access options for their patient population; these options will include EHR and Medicare. A small percentage of participants may be enrolled from underrepresented populations for whom a substantial amount of utilization records cannot be accessed with written approval from the study PI. All participants must be affiliated with one of the 6 participating health systems:
- Ochsner Health System Providence Health \& Services Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center HealthPartners Institute University of Colorado, Denver University of California, San Francisco
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 |
|---|---|---|
| Care EcosystemApplying the principles of person-and-family centered and collaborative care to dementia, the Care Ecosystem (CE) offers proactive, protocol-guided phone- and web-based caregiver support, guidance, and care coordination that extends the reach of dementia primary and specialty care. Care is delivered primarily via the phone and web by unlicensed Care Team Navigators (CTNs), who are trained and supervised by a team of dementia specialists with nursing, social work, and pharmacy expertise. Care Protocols guide proactive, quality care that is documented in the electronic health record (EHR). The CTN is an unlicensed, trained dementia care guide who served as the PWD's and caregiver's primary point of contact to the program under nurse supervision. Care team navigators respond to caregivers' immediate needs first, then screen for common problems and provide personalized support and standardized education using the care plan protocols. | Behavioural | Care Ecosystem |
Primary outcome
Dementia Management Quality Measurement Set
Time frame: Baseline to 12 months
The rate of completion of a 10-item, adapted Dementia Management Quality Measurement Set. This count variable has a range of 0 (no dementia quality care elements completed) to 10 (all dementia quality care elements completed).
Change in emergency department (ED) visits
Time frame: Baseline to 12 months
Number of PWD ED visits, using claims and EHRs.
Change in potentially inappropriate medications for dementia or cognitive impairment
Time frame: Baseline to 12 months
Number of high-risk medications used, operationalized using the 2019 Beers criteria, using medication lists from the EHR.
Change in caregiver depression
Time frame: Baseline to 12 months
Caregiver depression will be measured by the 9-item Patient Health Questionnaire (PHQ-9), ranging from 0-27 points, with higher scores indicating more severe depression.
6 secondary outcomes
Change in PWD hospitalizations
Time frame: Baseline to 12 months
Change in PWD annual bed days
Time frame: Baseline to 12 months
Change in central nervous system (CNS) acting medications
Time frame: Baseline to 12 months
Change in caregiver burden
Time frame: Baseline to 12 months
Change in caregiver self-efficacy
Time frame: Baseline to 12 months
Change in caregiver anxiety
Time frame: Baseline to 12 months
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 2 Sep 2025.
- Background: PubMed 30094817Peipert JD, Jennings LA, Hays RD, Wenger NS, Keeler E, Reuben DB. A Composite Measure of Caregiver Burden in Dementia: The Dementia Burden Scale-Caregiver. J Am Geriatr Soc. 2018 Sep;66(9):1785-1789. doi: 10.1111/jgs.15502. Epub 2018 Aug 10.
- Background: PubMed 31566651Possin KL, Merrilees JJ, Dulaney S, Bonasera SJ, Chiong W, Lee K, Hooper SM, Allen IE, Braley T, Bernstein A, Rosa TD, Harrison K, Begert-Hellings H, Kornak J, Kahn JG, Naasan G, Lanata S, Clark AM, Chodos A, Gearhart R, Ritchie C, Miller BL. Effect of Collaborative Dementia Care via Telephone and Internet on Quality of Life, Caregiver Well-being, and Health Care Use: The Care Ecosystem Randomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1658-1667. doi: 10.1001/jamainternmed.2019.4101.
- Background: PubMed 30497302Merrilees JJ, Bernstein A, Dulaney S, Heunis J, Walker R, Rah E, Choi J, Gawlas K, Carroll S, Ong P, Feuer J, Braley T, Clark AM, Lee K, Chiong W, Bonasera SJ, Miller BL, Possin KL. The Care Ecosystem: Promoting self-efficacy among dementia family caregivers. Dementia (London). 2020 Aug;19(6):1955-1973. doi: 10.1177/1471301218814121. Epub 2018 Nov 29.
- Background: PubMed 36331050Liu AK, Possin KL, Cook KM, Lynch S, Dulaney S, Merrilees JJ, Braley T, Kiekhofer RE, Bonasera SJ, Allen IE, Chiong W, Clark AM, Feuer J, Ewalt J, Guterman EL, Gearhart R, Miller BL, Lee KP. Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. Alzheimers Dement. 2023 May;19(5):1865-1875. doi: 10.1002/alz.12808. Epub 2022 Nov 4.
- Individual participant dataSharing planned: Yes. Investigators will submit resource requests for archived data through a Qualtrics-based form, which will include a signed "Data Use Agreement". These will be reviewed monthly by the investigators. If a request is approved, the study staff will review the requested dataset to ensure it is de-identified and encrypted for transfer, along with a data dictionary.
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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.
Katherine L Possin, PhD principal investigator
University of California, San Francisco
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Ecosystem in people with Dementia and Dementia, Vascular, run by University of California, San Francisco at 6 sites 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 11 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 2 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 6 sites 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?
Dementia Management Quality Measurement Set (time frame: Baseline to 12 months). The study lists 4 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 NCT05669365, which also lists 4 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 2 Sep 2025.