Mild Cognitive ImpairmentNCT05934344
Effectiveness of an Intervention Using Observation/Action Therapy Among Patients With Mild Cognitive Impairment
A study testing Action observation training in people with Mild Cognitive Impairment and Age-associated Memory Impairment, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
Mild cognitive impairment (MCI) is a transitional state between normal aging and early dementia, characterized by memory deficits without functional impairment. Cognitive decline prevalence is increasing in older adults, impacting independence and quality of life. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Age-associated Memory Impairment
- What is being tested?
- Action observation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2023to 20 Jul 2023
- 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Residents or day care center users without visual or auditory impairments that cannot be corrected with the use of devices (such as glasses or hearing aids) and without any conditions affecting their upper limbs.
- Residents with mild cognitive impairment (MoCA score <26) (23).
- Patients capable of walking at least 10 meters without severe pain in the lower limbs (according to the Visual Analog Scale).
- Patiens capable to perform the tests without the use of external aids or with the use of assistive devices such as a cane, and without medical contraindications for exercise.
Who cannot join
- The patients without cognitive impairment will be selected based on a MoCA score ranging from 26 to 30,
- Patients without any other neurological or musculoskeletal pathology.
- Patients with no upper limb disorders.
- Patients inability to complete the intervention full-time,
- Patients with presence of aggressive behavior or disturbances,
- Patients with inability to communicate verbally.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Cecilia Estrada Barranco
Villaviciosa de Odón, Madrid, 28670
Cecilia Estrada Barranco, PhD, 686166483, cecilia.estrada@universidadeuropea.es
About this study
Official title: Assessment of Motor and Social Changes Following Intervention With Observation/Action Training (AOT) Among Patients With Mild Cognitive Impairment
Mild cognitive impairment (MCI) is a transitional state between normal aging and early dementia, characterized by memory deficits without functional impairment. Cognitive decline prevalence is increasing in older adults, impacting independence and quality of life. Motor dysfunctions, often overlooked in MCI, contribute to these limitations. Action Observation Therapy (AOT), a rehabilitation approach involving observing and imitating motor gestures, promotes brain plasticity through the mirror neuron system. While AOT has shown effectiveness in various populations, its application in MCI is understudied. This study aims to investigate the effects of AOT on cognition, upper and lower limb function, daily activities, gait, and balance in MCI patients. It also compares outcomes when patients observe therapists or MCI individuals with similar characteristics. Primary objectives include comparing AOT efficacy between these groups and a control group. Secondary objectives focus on upper limb functionality, daily activities, balance, cognition, and gait.
Read the detailed description
Introduction The term MCI (Mild Cognitive Impairment) refers to the transitional state between normal cognitive changes associated with aging and very early dementia. It is a disorder characterized by impairments in both short-term and long-term memory, but without functional deficits. MCI is considered a precursor to dementia.
According to the World Health Organization (WHO), it was estimated that in 2014 there were 5.0 million adults with cognitive impairment (CI) in the population aged 65 years and older, and it is projected that by 2060, this number will increase to nearly 14 million. A study by Gómez on sentinel health networks in Spain describes a prevalence of MCI among individuals aged 65 years and older ranging from 14.5% to 17.6% , which increases with age. Another study reports a prevalence of 11.6% in individuals aged 65 to 69 years, which rises to an average of 22.9% among those aged 85 years and older. Furthermore, a meta-analysis of 9 Spanish studies on different types of dementia showed a prevalence ranging from 3.2% to 12.3% in individuals aged 70 years and older, with higher prevalence in women and increasing with age.
Activities of daily living (ADL) rely on a combination of motor, cognitive, and socioemotional skills . Therefore, CI can directly impact independence in ADL, leading to immobility and social isolation . These factors increase the likelihood of individuals with CI requiring admission to specialized care centers.
Gait and balance impairments are common in individuals with dementia, including slower gait speeds, decreased stride length, altered swing time, among others. However, these motor alterations are often overlooked when addressing CI . Balance impairment combined with gait deficits significantly increases the risk of falls, with approximately 60% of individuals with CI experiencing falls annually, twice as frequently as cognitively intact counterparts . Individuals with CI are also more prone to falls resulting in injuries, with up to a three-fold increase in the incidence of hip fractures compared to those without CI. Recognizing and addressing this connection between cognitive and motor deficits is crucial .
A systematic review from 2018 concluded that combining physical training with cognitive training in a functional context can help mitigate some aspects of CI. Therefore, the evidence supports that cognitive intervention should be concurrent with physical exercises rather than separate .
Action Observation Therapy (AOT) involves observing a motor gesture performed by another individual and then imitating the same movement. This technique has been developed as a physical rehabilitation approach that promotes brain plasticity by activating the mirror neuron system . Previous studies have demonstrated the effectiveness of action observation learning. A study conducted with children with cerebral palsy, presented by Naura et al. , showed that motor learning through observation is more effective and provides more evident benefits when subjects learn from other patients with the same condition but less severity, compared to learning by observing a therapist or another person without motor impairment. However, these results have not been corroborated in older patients or those with CI.
The current literature includes various studies consistently demonstrating that AOT is an effective way to learn or improve specific motor skills. Buccino's work summarizes several studies that have employed AOT, including one in which the intervention was carried out with healthy individuals to imitate a motor action in a new environment for them. Another study showed that AOT facilitates motor learning and the construction of a motor memory trace in adults and in patients who have had a stroke. In another study, it was demonstrated that, in healthy adults, AOT is superior to motor imagery as a strategy for learning a complex motor task, at least in the early phase of motor learning. Buccino concludes that these results can have significant implications in educational activities, sports training, and neurorehabilitation.
Specifically in the field of pathology, evidence exists regarding the application of AOT for upper limb rehabilitation in patients who have had a stroke. A pilot study by Yu-Wei Hsieh concluded that AOT resulted in improvements in most outcomes, suggesting it as a promising alternative to contemporary bilateral arm training interventions (i.e., active control intervention) for subacute stroke patients . In a randomized controlled pilot study by Mancuso et al., it was proposed that AOT is a promising treatment for functional recovery and upper limb function in individuals with moderate to severe upper limb impairment following a stroke. AOT could become a useful strategy in stroke rehabilitation programs, as it improves functionality of the paretic upper limb and allows for regaining maximum independence in ADL . Evidence also exists for AOT in children diagnosed with cerebral palsy, specifying that AOT increases spontaneous use of the affected upper limb through observation and imitation of actions, encouraging children to participate in daily activities. By focusing on functional goals or representing everyday activities, these proposed activities promote automatic use within the everyday environment .
However, upon conducting a search for articles and information, no studies on AOT in patients with MCI for upper limb or lower limb activities were found. The closest finding was an article by Rojasavastera, Rommanee et al., in which AOT combined with gait training was used to improve gait and cognition in older adults with MCI. This is why the proposal for this study was initiated (20).
Therefore, the aim of this study is to investigate whether applying AOT in a population with MCI would yield positive results in cognitive status, upper limb function, ADL, gait, and balance. Furthermore, the study aims to determine whether there are better outcomes when AOT is conducted under the guidance of a therapist or under the direction of MCI-free individuals, compared to self-directed AOT.
Hypothesis and Objectives:
The hypothesis of this study is that intervention using an exercise plan for upper and lower limbs through action observation learning is effective in improving cognitive status, functionality, ADL, gait, and balance in patients with mild cognitive impairment. It is also hypothesized that this effectiveness is greater when the learning process involves observing actions performed by other patients with similar characteristics, compared to observing actions performed by the therapist.
Main Objective:
To compare the effectiveness of action observation therapy in patients with mild cognitive impairment who observe the therapist, patients with mild cognitive impairment who observe patients without cognitive impairment, and a control group.
Secondary Objectives:
To assess the benefits of an exercise plan using action observation learning on upper limb functionality.
To evaluate the effectiveness of an exercise plan using action observation learning on ADL in patients.
To examine the benefits of an exercise plan using action observation learning on balance.
To determine the effects of an exercise plan using action observation learning on cognitive status.
To investigate the impact of an exercise plan using action observation learning on gait.
- Being tested
- Action observation training
- Keywords
- Action observation treatment, Dementia, Cognitive impairment, Mirror neurons, Elderly people
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observation trainingOther
The activities proposed will be based on items from the FMA scale (Voluntary movement within synergies, voluntary movement mixing synergies, voluntary movement with little or no synergy, grip, coordination/speed, passive joint movement), and the exercises for the lower limbs will be designed by the authors of the study, based on Vivifrail (32), a multicomponent physical training program for the prevention of deconditioning and falls in older adults. These exercises will be progressive each week, focusing on strengthening, balance, and functional exercises to improve gait. The sessions will last between 20 and 30 minutes, with a frequency of three days per week. The intervention will last for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Observational learning from the therapist | Experimental | Patients with MCI (Mild Cognitive Impairment) will undergo intervention using therapist-led imitation exercises. They will engage in a 5-week exercise program based on observation and action. Data will be collected at the beginning and end of the program. Receives: Other: Action observation training |
| peer learning | Experimental | Patients with MCI (Mild Cognitive Impairment) will undergo intervention using exercises by imitation from individuals residing in the facility but without cognitive impairment. They will participate in a 5-week exercise program based on observation and action. Data will be collected at the beginning and end of the program. Receives: Other: Action observation training |
| control group | No intervention | Patients with cognitive impairment who will receive the standard treatment provided by the facility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes cognitive impairment
Montreal Cognitive Assessment (MoCA)
Measured: Before and after the intervention: 5 weeks
Changes Activities of daily living
Barthel index
Measured: Before and after the intervention: 5 weeks
Changes Functionality
Fugl-meyer scale
Measured: Before and after the intervention: 5 weeks
Changes Upper limb dexterity
Box and block test
Measured: Before and after the intervention: 5 weeks
Changes balance
Berg Balance Scale
Measured: Before and after the intervention: 5 weeks
Changes gait
10 Meters Walking Tes
Measured: Before and after the intervention: 5 weeks
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 start1 Apr 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion20 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Estrada Barranco, Universidad Europea de Madrid
- Investigators
- Cecilia Estrada Barranco, PhD, Study director, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934344
- Sponsor's protocol ID
- Universidad Europea
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Motor and Social Changes Following Intervention With Observation/Action Training (AOT) Among Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05934344
- Acronym / sponsor ID
- Universidad Europea
- Keywords
- Action observation treatment, Dementia, Cognitive impairment, Mirror neurons, Elderly people
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 20 Jul 2023 (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.
Mild cognitive impairment (MCI) is a transitional state between normal aging and early dementia, characterized by memory deficits without functional impairment. Cognitive decline prevalence is increasing in older adults, impacting independence and quality of life. Motor dysfunctions, often overlooked in MCI, contribute to these limitations. Action Observation Therapy (AOT), a rehabilitation approach involving observing and imitating motor gestures, promotes brain plasticity through the mirror neuron system. While AOT has shown effectiveness in various populations, its application in MCI is understudied. This study aims to investigate the effects of AOT on cognition, upper and lower limb function, daily activities, gait, and balance in MCI patients. It also compares outcomes when patients observe therapists or MCI individuals with similar characteristics. Primary objectives include comparing AOT efficacy between these groups and a control group. Secondary objectives focus on upper limb functionality, daily activities, balance, cognition, and gait.
Detailed description
Introduction The term MCI (Mild Cognitive Impairment) refers to the transitional state between normal cognitive changes associated with aging and very early dementia. It is a disorder characterized by impairments in both short-term and long-term memory, but without functional deficits. MCI is considered a precursor to dementia.
According to the World Health Organization (WHO), it was estimated that in 2014 there were 5.0 million adults with cognitive impairment (CI) in the population aged 65 years and older, and it is projected that by 2060, this number will increase to nearly 14 million. A study by Gómez on sentinel health networks in Spain describes a prevalence of MCI among individuals aged 65 years and older ranging from 14.5% to 17.6% , which increases with age. Another study reports a prevalence of 11.6% in individuals aged 65 to 69 years, which rises to an average of 22.9% among those aged 85 years and older. Furthermore, a meta-analysis of 9 Spanish studies on different types of dementia showed a prevalence ranging from 3.2% to 12.3% in individuals aged 70 years and older, with higher prevalence in women and increasing with age.
Activities of daily living (ADL) rely on a combination of motor, cognitive, and socioemotional skills . Therefore, CI can directly impact independence in ADL, leading to immobility and social isolation . These factors increase the likelihood of individuals with CI requiring admission to specialized care centers.
Gait and balance impairments are common in individuals with dementia, including slower gait speeds, decreased stride length, altered swing time, among others. However, these motor alterations are often overlooked when addressing CI . Balance impairment combined with gait deficits significantly increases the risk of falls, with approximately 60% of individuals with CI experiencing falls annually, twice as frequently as cognitively intact counterparts . Individuals with CI are also more prone to falls resulting in injuries, with up to a three-fold increase in the incidence of hip fractures compared to those without CI. Recognizing and addressing this connection between cognitive and motor deficits is crucial .
A systematic review from 2018 concluded that combining physical training with cognitive training in a functional context can help mitigate some aspects of CI. Therefore, the evidence supports that cognitive intervention should be concurrent with physical exercises rather than separate .
Action Observation Therapy (AOT) involves observing a motor gesture performed by another individual and then imitating the same movement. This technique has been developed as a physical rehabilitation approach that promotes brain plasticity by activating the mirror neuron system . Previous studies have demonstrated the effectiveness of action observation learning. A study conducted with children with cerebral palsy, presented by Naura et al. , showed that motor learning through observation is more effective and provides more evident benefits when subjects learn from other patients with the same condition but less severity, compared to learning by observing a therapist or another person without motor impairment. However, these results have not been corroborated in older patients or those with CI.
The current literature includes various studies consistently demonstrating that AOT is an effective way to learn or improve specific motor skills. Buccino's work summarizes several studies that have employed AOT, including one in which the intervention was carried out with healthy individuals to imitate a motor action in a new environment for them. Another study showed that AOT facilitates motor learning and the construction of a motor memory trace in adults and in patients who have had a stroke. In another study, it was demonstrated that, in healthy adults, AOT is superior to motor imagery as a strategy for learning a complex motor task, at least in the early phase of motor learning. Buccino concludes that these results can have significant implications in educational activities, sports training, and neurorehabilitation.
Specifically in the field of pathology, evidence exists regarding the application of AOT for upper limb rehabilitation in patients who have had a stroke. A pilot study by Yu-Wei Hsieh concluded that AOT resulted in improvements in most outcomes, suggesting it as a promising alternative to contemporary bilateral arm training interventions (i.e., active control intervention) for subacute stroke patients . In a randomized controlled pilot study by Mancuso et al., it was proposed that AOT is a promising treatment for functional recovery and upper limb function in individuals with moderate to severe upper limb impairment following a stroke. AOT could become a useful strategy in stroke rehabilitation programs, as it improves functionality of the paretic upper limb and allows for regaining maximum independence in ADL . Evidence also exists for AOT in children diagnosed with cerebral palsy, specifying that AOT increases spontaneous use of the affected upper limb through observation and imitation of actions, encouraging children to participate in daily activities. By focusing on functional goals or representing everyday activities, these proposed activities promote automatic use within the everyday environment .
However, upon conducting a search for articles and information, no studies on AOT in patients with MCI for upper limb or lower limb activities were found. The closest finding was an article by Rojasavastera, Rommanee et al., in which AOT combined with gait training was used to improve gait and cognition in older adults with MCI. This is why the proposal for this study was initiated (20).
Therefore, the aim of this study is to investigate whether applying AOT in a population with MCI would yield positive results in cognitive status, upper limb function, ADL, gait, and balance. Furthermore, the study aims to determine whether there are better outcomes when AOT is conducted under the guidance of a therapist or under the direction of MCI-free individuals, compared to self-directed AOT.
Hypothesis and Objectives:
The hypothesis of this study is that intervention using an exercise plan for upper and lower limbs through action observation learning is effective in improving cognitive status, functionality, ADL, gait, and balance in patients with mild cognitive impairment. It is also hypothesized that this effectiveness is greater when the learning process involves observing actions performed by other patients with similar characteristics, compared to observing actions performed by the therapist.
Main Objective:
To compare the effectiveness of action observation therapy in patients with mild cognitive impairment who observe the therapist, patients with mild cognitive impairment who observe patients without cognitive impairment, and a control group.
Secondary Objectives:
To assess the benefits of an exercise plan using action observation learning on upper limb functionality.
To evaluate the effectiveness of an exercise plan using action observation learning on ADL in patients.
To examine the benefits of an exercise plan using action observation learning on balance.
To determine the effects of an exercise plan using action observation learning on cognitive status.
To investigate the impact of an exercise plan using action observation learning on gait.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational learning from the therapist | Experimental | Other: Action observation trainingPatients with MCI (Mild Cognitive Impairment) will undergo intervention using therapist-led imitation exercises. They will engage in a 5-week exercise program based on observation and action. Data will be collected at the beginning and end of the program. |
| peer learning | Experimental | Other: Action observation trainingPatients with MCI (Mild Cognitive Impairment) will undergo intervention using exercises by imitation from individuals residing in the facility but without cognitive impairment. They will participate in a 5-week exercise program based on observation and action. Data will be collected at the beginning and end of the program. |
| control group | No intervention | –Patients with cognitive impairment who will receive the standard treatment provided by the facility. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Residents or day care center users without visual or auditory impairments that cannot be corrected with the use of devices (such as glasses or hearing aids) and without any conditions affecting their upper limbs.
- Residents with mild cognitive impairment (MoCA score <26) (23).
- Patients capable of walking at least 10 meters without severe pain in the lower limbs (according to the Visual Analog Scale).
- Patiens capable to perform the tests without the use of external aids or with the use of assistive devices such as a cane, and without medical contraindications for exercise.
Key exclusion criteria (6 listed)
- The patients without cognitive impairment will be selected based on a MoCA score ranging from 26 to 30,
- Patients without any other neurological or musculoskeletal pathology.
- Patients with no upper limb disorders.
- Patients inability to complete the intervention full-time,
- Patients with presence of aggressive behavior or disturbances,
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 |
|---|---|---|
| Action observation trainingThe activities proposed will be based on items from the FMA scale (Voluntary movement within synergies, voluntary movement mixing synergies, voluntary movement with little or no synergy, grip, coordination/speed, passive joint movement), and the exercises for the lower limbs will be designed by the authors of the study, based on Vivifrail (32), a multicomponent physical training program for the prevention of deconditioning and falls in older adults. These exercises will be progressive each week, focusing on strengthening, balance, and functional exercises to improve gait. The sessions will last between 20 and 30 minutes, with a frequency of three days per week. The intervention will last for 5 weeks. | Other | Observational learning from the therapist, peer learning |
Primary outcome
Changes cognitive impairment
Time frame: Before and after the intervention: 5 weeks
Montreal Cognitive Assessment (MoCA)
Changes Activities of daily living
Time frame: Before and after the intervention: 5 weeks
Barthel index
Changes Functionality
Time frame: Before and after the intervention: 5 weeks
Fugl-meyer scale
Changes Upper limb dexterity
Time frame: Before and after the intervention: 5 weeks
Box and block test
Changes balance
Time frame: Before and after the intervention: 5 weeks
Berg Balance Scale
Changes gait
Time frame: Before and after the intervention: 5 weeks
10 Meters Walking Tes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- 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.
Cecilia Estrada Barranco, PhD study director
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action observation training in people with Mild Cognitive Impairment and Age-associated Memory Impairment, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Estrada Barranco, PhD (686166483, cecilia.estrada@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes cognitive impairment (time frame: Before and after the intervention: 5 weeks). The study lists 6 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 6 Jul 2023.