AgingI-COACHNCT05932342
Improving Cognition of Older Adults in Community Housing
A study testing Integrated program of cognitive remediation, physical exercise and socially stimulating activity in people with Aging and Mental Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The I-COACH study will focus on seniors with mental health conditions who are living in senior community housing. This initiative proposes to assess the feasibility and acceptability of a 12-week integrated program of cognitive remediation (CR) in combination with social and physical activity using an open-label… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aging, Mental Disorder
- What is being tested?
- Integrated program of cognitive remediation, physical exercise and socially stimulating activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 years and above. The rationale of age cutoff of 50 is that this age is considered a typical geriatric age cutoff especially for people with severe mental illness
- Any race or ethnicity
- Any gender identity
- Meets DSM-V criteria for any disorder
- Clinically stable as operationalized by (1) having not been admitted to a psychiatric hospital within the 3 months prior to assessment, (2) having had no change in psychotropic medication dosage within the 4 weeks prior to assessment, and (3) ascertained to be clinically and medically stable by one the study psychiatrists.
- Willingness and ability to speak English
- Willingness to provide informed consent or assent as applicable.
- Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice. Both vision and hearing ability will be assessed by asking the participant if they can see the text and hear the research personnel during the screening consent and enrolment process.
Who cannot join
- Meets diagnostic criteria for active substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine
- Has profound cognitive impairment that, in the opinion of the PI, precludes benefit from CR and therefore study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Cognition of Older Adults in Community Housing (I-COACH)
The I-COACH study will focus on seniors with mental health conditions who are living in senior community housing. This initiative proposes to assess the feasibility and acceptability of a 12-week integrated program of cognitive remediation (CR) in combination with social and physical activity using an open-label design. The program will be provided over three iterative groups of six participants each, with one Personal Support Worker (PSW). The program will be co-designed at a granular level in an iterative process, drawing upon feedback provided by each participant group, PSW, and community housing staff to improve the user experience.
We will build the capacity for community personal support workers (PSWs) to deliver this program independently and with fidelity to the intervention model. Our ultimate goal is to help seniors continue to live as long as possible in their homes within the community.
Read the detailed description
This project entails the development and implementation of a12-week integrated program of cognitive remediation (CR) in combination with social and physical activity of 18 older adults living in senior housing.
The study will be recruiting individuals, age 50 or older, who meet criteria for any Diagnostic and Statistical Manual of Mental Disorders (DSM)-V diagnosis and are living in community housing.
Participants will be recruited from five senior housing units. Prior to enrollment, participants will undergo a baseline assessment consistent of neuropsychological assessment (NP). Once enrolled, each participant will participate in the 12 - weeks program. The program will be offered 4 days per week and will consist of 2 days of 1-hour CR training, one day of 30 min physical activity and one day of 1-hour social activity. The intervention will be delivered by the research team and the senior community housing PSWs. The PSWs involved in the study are part of the participant's circle of care and will be trained and operating under supervision in collaboration with the research team.
Following the completion of the 12-week program, group participants and staff will be invited to complete a satisfaction survey and the System Usability Scale (SUS) to gauge their feedback to the program and also to complete a semi-structured interview involving a qualitative assessment.
Primary Aim:
To design a feasible and tolerable active program for seniors living in the community setting.
Secondary Aim:
To modify CR using an iterative process that meets the capacity of senior community housing PSWs to deliver CR independently.
- Conditions
- Aging, Mental Disorder
- Being tested
- Integrated program of cognitive remediation, physical exercise and socially stimulating activity
- Keywords
- cognitive remediation, social activity, exercise, aging, community
- Medical subject headings
- Mental Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated program of cognitive remediation, physical exercise and socially stimulating activityBehavioural
Cognitive Remediation (CR) is a well-established intervention that aims to improve neurocognitive abilities (such as memory performance, executive functioning, processing speed, and attention) using four techniques: didactic teaching, computerized drills, in-class strategic monitoring and discussions of the generalization of cognitive skills to daily life.
The physical exercise component consists of physical activities designed for the geriatric population that aim to reduce sedentary behaviors while increasing social engagement.
The socially stimulating activity aim to decrease social isolation, improve well-being, community connection and rapport.
| Study group | Role | What they receive |
|---|---|---|
| Integrated program of cognitive remediation, physical exercise and socially- stimulating activity | Experimental | Cognitive Remediation (CR) is a well-established intervention that aims to improve neurocognitive abilities (such as memory performance, executive functioning, processing speed, and attention) using four techniques: didactic teaching, computerized drills, in-class strategic monitoring and discussions of the generalization of cognitive skills to daily life.
The physical exercise component consists of physical activities designed for the geriatric population that aim to reduce sedentary behaviors while increasing social engagement.
The socially stimulating activity aim to decrease social isolation, improve well-being, community connection and rapport.
The integrated, 12-week, group-based program consists of CR 1h/day, 2 days/week, 30min of physical exercises 1day/week and 1h of socially stimulating activities 1day/week Receives: Behavioral: Integrated program of cognitive remediation, physical exercise and socially stimulating activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's satisfaction
This is measured using the Satisfaction Survey which assesses participants' agreement on 10 statements each measuring the degree of agreement or disagreement of participants using a 7-point Likert Scale. Minimum score is 10 and maximum score is 70. Higher scores indicate better satisfaction.
Measured: end of week 12 of the intervention
Acceptability and Usability of Cognitive Remediation
This is assessed using the System Usability Scale (SUS). The scale is comprised of 10 statements each measuring the degree of agreement or disagreement of participants using 5 -point Likert Scale. Minimum score is 0 and maximum is 100. Higher scores indicate better usability.
Measured: end of week 12 of the intervention
Participants' feedback of the program
Semi-structured qualitative interview
Measured: end of week 12 of the intervention
Staff Feedback of the program
Semi-structured qualitative interview
Measured: Within one week from the end of week 12 of the intervention
Sessions and overall program attendance
Attendance logs
Measured: end of week 12 of the intervention
Secondary outcomes (1)
Staff Feedback of the delivery of the program
Semi-structured qualitative interview
Measured: Within one week from the end of week 12 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start4 Jul 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention will be provided over 3 iterative group of 6 participants each
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- LOFT Community Services
- Responsible party
- Sponsor
- Investigators
- Angela Golas, MD, Principal investigator, Center for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932342
- Sponsor's protocol ID
- 027 - 2023
- Acronym
- I-COACH
- Status last verified
- Apr 2026
- First submitted
- 27 Jun 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gilmer T, Ojeda VD, Folsom D, Fuentes D, Criado V, Garcia P, Jeste DV. Costs of community-based public mental health services for older adults: variations related to age and diagnosis. Int J Geriatr Psychiatry. 2006 Dec;21(12):1121-6. doi: 10.1002/gps.1616.
PubMed 16977681Bangor A, Kortum PT,Miller JT: An Empirical Evaluation of the System Usability Scale. International Journal of Human Computer Interaction 2008; 24:574-594
Arrieta H, Rezola-Pardo C, Echeverria I, Iturburu M, Gil SM, Yanguas JJ, Irazusta J, Rodriguez-Larrad A. Physical activity and fitness are associated with verbal memory, quality of life and depression among nursing home residents: preliminary data of a randomized controlled trial. BMC Geriatr. 2018 Mar 27;18(1):80. doi: 10.1186/s12877-018-0770-y.
PubMed 29580209Gremeaux V, Gayda M, Lepers R, Sosner P, Juneau M, Nigam A. Exercise and longevity. Maturitas. 2012 Dec;73(4):312-7. doi: 10.1016/j.maturitas.2012.09.012. Epub 2012 Oct 11.
PubMed 23063021Vagetti GC, Barbosa Filho VC, Moreira NB, Oliveira Vd, Mazzardo O, Campos Wd. Association between physical activity and quality of life in the elderly: a systematic review, 2000-2012. Braz J Psychiatry. 2014 Jan-Mar;36(1):76-88. doi: 10.1590/1516-4446-2012-0895. Epub 2014 Jan 17.
PubMed 24554274Glass TA, De Leon CF, Bassuk SS, Berkman LF. Social engagement and depressive symptoms in late life: longitudinal findings. J Aging Health. 2006 Aug;18(4):604-28. doi: 10.1177/0898264306291017.
PubMed 16835392Cornwell EY, Waite LJ. Social disconnectedness, perceived isolation, and health among older adults. J Health Soc Behav. 2009 Mar;50(1):31-48. doi: 10.1177/002214650905000103.
PubMed 19413133McHugh JE, Lawlor BA. Exercise and social support are associated with psychological distress outcomes in a population of community-dwelling older adults. J Health Psychol. 2012 Sep;17(6):833-44. doi: 10.1177/1359105311423861. Epub 2011 Nov 22.
PubMed 22108290Krivanek TJ, Gale SA, McFeeley BM, Nicastri CM, Daffner KR. Promoting Successful Cognitive Aging: A Ten-Year Update. J Alzheimers Dis. 2021;81(3):871-920. doi: 10.3233/JAD-201462.
PubMed 33935078Reijnders J, van Heugten C, van Boxtel M. Cognitive interventions in healthy older adults and people with mild cognitive impairment: a systematic review. Ageing Res Rev. 2013 Jan;12(1):263-75. doi: 10.1016/j.arr.2012.07.003. Epub 2012 Jul 25.
PubMed 22841936Golas AC, Kalache SM, Tsoutsoulas C, Mulsant BH, Bowie CR, Rajji TK. Cognitive remediation for older community-dwelling individuals with schizophrenia: a pilot and feasibility study. Int J Geriatr Psychiatry. 2015 Nov;30(11):1129-34. doi: 10.1002/gps.4329. Epub 2015 Aug 6.
PubMed 26250542Harvey PD, Bowie CR. Cognitive enhancement in schizophrenia: pharmacological and cognitive remediation approaches. Psychiatr Clin North Am. 2012 Sep;35(3):683-98. doi: 10.1016/j.psc.2012.06.008. Epub 2012 Jul 15.
PubMed 22929873Kurtz MM. Cognitive remediation for schizophrenia: current status, biological correlates and predictors of response. Expert Rev Neurother. 2012 Jul;12(7):813-21. doi: 10.1586/ern.12.71.
PubMed 22853789HAPPYneuron I: Scientific Brain Training PRO, Campbell, CA, USA, 2009.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cognition of Older Adults in Community Housing (I-COACH)
- ClinicalTrials.gov ID
- NCT05932342
- Acronym / sponsor ID
- I-COACH / 027 - 2023
- Conditions
- Aging, Mental Disorder
- Keywords
- cognitive remediation, social activity, exercise, aging, community
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- LOFT Community Services
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Jul 2023 (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 I-COACH study will focus on seniors with mental health conditions who are living in senior community housing. This initiative proposes to assess the feasibility and acceptability of a 12-week integrated program of cognitive remediation (CR) in combination with social and physical activity using an open-label design. The program will be provided over three iterative groups of six participants each, with one Personal Support Worker (PSW). The program will be co-designed at a granular level in an iterative process, drawing upon feedback provided by each participant group, PSW, and community housing staff to improve the user experience.
We will build the capacity for community personal support workers (PSWs) to deliver this program independently and with fidelity to the intervention model. Our ultimate goal is to help seniors continue to live as long as possible in their homes within the community.
Detailed description
This project entails the development and implementation of a12-week integrated program of cognitive remediation (CR) in combination with social and physical activity of 18 older adults living in senior housing.
The study will be recruiting individuals, age 50 or older, who meet criteria for any Diagnostic and Statistical Manual of Mental Disorders (DSM)-V diagnosis and are living in community housing.
Participants will be recruited from five senior housing units. Prior to enrollment, participants will undergo a baseline assessment consistent of neuropsychological assessment (NP). Once enrolled, each participant will participate in the 12 - weeks program. The program will be offered 4 days per week and will consist of 2 days of 1-hour CR training, one day of 30 min physical activity and one day of 1-hour social activity. The intervention will be delivered by the research team and the senior community housing PSWs. The PSWs involved in the study are part of the participant's circle of care and will be trained and operating under supervision in collaboration with the research team.
Following the completion of the 12-week program, group participants and staff will be invited to complete a satisfaction survey and the System Usability Scale (SUS) to gauge their feedback to the program and also to complete a semi-structured interview involving a qualitative assessment.
Primary Aim:
To design a feasible and tolerable active program for seniors living in the community setting.
Secondary Aim:
To modify CR using an iterative process that meets the capacity of senior community housing PSWs to deliver CR independently.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention will be provided over 3 iterative group of 6 participants each
| Arm | Type | Receives |
|---|---|---|
| Integrated program of cognitive remediation, physical exercise and socially- stimulating activity | Experimental | Behavioral: Integrated program of cognitive remediation, physical exercise and socially stimulating activityCognitive Remediation (CR) is a well-established intervention that aims to improve neurocognitive abilities (such as memory performance, executive functioning, processing speed, and attention) using four techniques: didactic teaching, computerized drills, in-class strategic monitoring and discussions of the generalization of cognitive skills to daily life. The physical exercise component consists of physical activities designed for the geriatric population that aim to reduce sedentary behaviors while increasing social engagement. The socially stimulating activity aim to decrease social isolation, improve well-being, community connection and rapport. The integrated, 12-week, group-based program consists of CR 1h/day, 2 days/week, 30min of physical exercises 1day/week and 1h of socially stimulating activities 1day/week |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 50 years and above. The rationale of age cutoff of 50 is that this age is considered a typical geriatric age cutoff especially for people with severe mental illness
- Any race or ethnicity
- Any gender identity
- Meets DSM-V criteria for any disorder
- Clinically stable as operationalized by (1) having not been admitted to a psychiatric hospital within the 3 months prior to assessment, (2) having had no change in psychotropic medication dosage within the 4 weeks prior to assessment, and (3) ascertained to be clinically and medically stable by one the study psychiatrists.
Key exclusion criteria (2 listed)
- Meets diagnostic criteria for active substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine
- Has profound cognitive impairment that, in the opinion of the PI, precludes benefit from CR and therefore study participation.
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 |
|---|---|---|
| Integrated program of cognitive remediation, physical exercise and socially stimulating activityCognitive Remediation (CR) is a well-established intervention that aims to improve neurocognitive abilities (such as memory performance, executive functioning, processing speed, and attention) using four techniques: didactic teaching, computerized drills, in-class strategic monitoring and discussions of the generalization of cognitive skills to daily life. The physical exercise component consists of physical activities designed for the geriatric population that aim to reduce sedentary behaviors while increasing social engagement. The socially stimulating activity aim to decrease social isolation, improve well-being, community connection and rapport. | Behavioural | Integrated program of cognitive remediation, physical exercise and socially- stimulating activity |
Primary outcome
Participant's satisfaction
Time frame: end of week 12 of the intervention
This is measured using the Satisfaction Survey which assesses participants' agreement on 10 statements each measuring the degree of agreement or disagreement of participants using a 7-point Likert Scale. Minimum score is 10 and maximum score is 70. Higher scores indicate better satisfaction.
Acceptability and Usability of Cognitive Remediation
Time frame: end of week 12 of the intervention
This is assessed using the System Usability Scale (SUS). The scale is comprised of 10 statements each measuring the degree of agreement or disagreement of participants using 5 -point Likert Scale. Minimum score is 0 and maximum is 100. Higher scores indicate better usability.
Participants' feedback of the program
Time frame: end of week 12 of the intervention
Semi-structured qualitative interview
Staff Feedback of the program
Time frame: Within one week from the end of week 12 of the intervention
Semi-structured qualitative interview
Sessions and overall program attendance
Time frame: end of week 12 of the intervention
Attendance logs
1 secondary outcome
Staff Feedback of the delivery of the program
Time frame: Within one week from the end of week 12 of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 16977681Gilmer T, Ojeda VD, Folsom D, Fuentes D, Criado V, Garcia P, Jeste DV. Costs of community-based public mental health services for older adults: variations related to age and diagnosis. Int J Geriatr Psychiatry. 2006 Dec;21(12):1121-6. doi: 10.1002/gps.1616.
- BackgroundBangor A, Kortum PT,Miller JT: An Empirical Evaluation of the System Usability Scale. International Journal of Human Computer Interaction 2008; 24:574-594
- Background: PubMed 29580209Arrieta H, Rezola-Pardo C, Echeverria I, Iturburu M, Gil SM, Yanguas JJ, Irazusta J, Rodriguez-Larrad A. Physical activity and fitness are associated with verbal memory, quality of life and depression among nursing home residents: preliminary data of a randomized controlled trial. BMC Geriatr. 2018 Mar 27;18(1):80. doi: 10.1186/s12877-018-0770-y.
- Background: PubMed 23063021Gremeaux V, Gayda M, Lepers R, Sosner P, Juneau M, Nigam A. Exercise and longevity. Maturitas. 2012 Dec;73(4):312-7. doi: 10.1016/j.maturitas.2012.09.012. Epub 2012 Oct 11.
- Background: PubMed 24554274Vagetti GC, Barbosa Filho VC, Moreira NB, Oliveira Vd, Mazzardo O, Campos Wd. Association between physical activity and quality of life in the elderly: a systematic review, 2000-2012. Braz J Psychiatry. 2014 Jan-Mar;36(1):76-88. doi: 10.1590/1516-4446-2012-0895. Epub 2014 Jan 17.
- Background: PubMed 16835392Glass TA, De Leon CF, Bassuk SS, Berkman LF. Social engagement and depressive symptoms in late life: longitudinal findings. J Aging Health. 2006 Aug;18(4):604-28. doi: 10.1177/0898264306291017.
- Background: PubMed 19413133Cornwell EY, Waite LJ. Social disconnectedness, perceived isolation, and health among older adults. J Health Soc Behav. 2009 Mar;50(1):31-48. doi: 10.1177/002214650905000103.
- Background: PubMed 22108290McHugh JE, Lawlor BA. Exercise and social support are associated with psychological distress outcomes in a population of community-dwelling older adults. J Health Psychol. 2012 Sep;17(6):833-44. doi: 10.1177/1359105311423861. Epub 2011 Nov 22.
- Background: PubMed 33935078Krivanek TJ, Gale SA, McFeeley BM, Nicastri CM, Daffner KR. Promoting Successful Cognitive Aging: A Ten-Year Update. J Alzheimers Dis. 2021;81(3):871-920. doi: 10.3233/JAD-201462.
- Background: PubMed 22841936Reijnders J, van Heugten C, van Boxtel M. Cognitive interventions in healthy older adults and people with mild cognitive impairment: a systematic review. Ageing Res Rev. 2013 Jan;12(1):263-75. doi: 10.1016/j.arr.2012.07.003. Epub 2012 Jul 25.
- Background: PubMed 26250542Golas AC, Kalache SM, Tsoutsoulas C, Mulsant BH, Bowie CR, Rajji TK. Cognitive remediation for older community-dwelling individuals with schizophrenia: a pilot and feasibility study. Int J Geriatr Psychiatry. 2015 Nov;30(11):1129-34. doi: 10.1002/gps.4329. Epub 2015 Aug 6.
- Background: PubMed 22929873Harvey PD, Bowie CR. Cognitive enhancement in schizophrenia: pharmacological and cognitive remediation approaches. Psychiatr Clin North Am. 2012 Sep;35(3):683-98. doi: 10.1016/j.psc.2012.06.008. Epub 2012 Jul 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Golas, MD principal investigator
Center for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated program of cognitive remediation, physical exercise and socially stimulating activity in people with Aging and Mental Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Participant's satisfaction (time frame: end of week 12 of the intervention). 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 NCT05932342, which also lists 14 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 13 Apr 2026.