AgingCOVEPICNCT04635462
The Cognitive and spOrt Virtual EPIC Training Study
A study testing Physical exercise training and Cognitive training in people with Aging, run by Louis Bherer at 1 site in Canada.
Trial summary
The proposed COVEPIC trial is designed to document the effects of remote monitoring of physical exercise and home-based cognitive training on cognitive and physical functions in older adults. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Physical exercise training and Cognitive training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteCanada
- Study dates
- 18 May 2020to 18 May 2022
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult aged 50 and older
- Have access to internet
- Have access to a tablet (i.e. iPad or Android) or a computer
Who cannot join
- Non-cardiopulmonary limitation to exercise (e.g., arthritis)
- Severe exercise intolerance
- Respiratory disease (e.g., asthma, COPD, COVID-19)
- Mini Mental Scale Examination (MMSE) telephone version lower than 19/23
- Diagnostic of cardiovascular disease (e.g., chronic systolic and diastolic heart failure, somatic aortic stenosis, atrial fibrillation, malignant arrhythmias, documented atherosclerotic disease).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
Montreal, Quebec, H1T1N6
About this study
Official title: The Cognitive and spOrt Virtual EPIC Training Study: INVESTIGATING THE EFFECTS OF HOME-BASED EXERCISE AND COGNITIVE TRAINING
The proposed COVEPIC trial is designed to document the effects of remote monitoring of physical exercise and home-based cognitive training on cognitive and physical functions in older adults.
Read the detailed description
Due to the actual pandemic of COVID-19 around the world, social distancing is recommended, which causes a reduction of social interaction and physical activity. Therefore, this health crisis may have collateral effects on cognitive, physical, and psychological health, especially in elderly people who are more likely to be isolated, and for whom social distancing is of paramount importance. Physical exercise practice has been demonstrated to improve cognitive functioning, along with mobility and physical capacity, and to promote psychological well-being. This is the reason why governmental health authorities, as well as the scientific community recommend to stay physically active, especially in this pandemic period. However, in the current context full-time physical training in sport centres cannot be largely promoted. Effective solutions to help older adults in maintaining regular and efficient physical exercise while maintaining social distancing, are thus needed. Consequently, the current project proposes first to investigate the potential of a remote monitoring of physical activity to promote cognitive, physical and psychological health of older adults. Also, considering the added benefits of combining cognitive training to physical exercise to further enhance health and cognition in seniors, this project also addresses the added benefits of a multidomain intervention combining a physical exercise intervention with a home-based cognitive training.
- Conditions
- Aging
- Being tested
- Physical exercise training, Cognitive training
- Keywords
- Aging, Remote monitoring, Home-based training, Cognitive Training, Physical Exercise, Cognition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise trainingOther
Participants will be encouraged to complete exercise training programs in the form of video capsules available via Facebook or Youtube, created by kinesiologists of the Montreal Heart Institut EPIC prevention center. The videos last about 15 minutes and include a warm-up of 3 to 5 minutes, followed a 10-minute training and finally a 2-minute cool-down period. The exercises on video do not require any equipment and integrate, depending on the video, aerobic, muscular strengthening, flexibility and/or balance exercises. Several intensities are described according to the participants' level. Participants will be invited to perform exercise sessions at least 5 times a week, and will be monitored weekly by phone by a member of the research team. The exercise sessions can be performed at home using the video training program, as well as in sports centre or outdoors. For each session, participants have to report its duration, intensity, and the nature of the activity via a follow-up agenda.
Cognitive trainingOther
Participants will be encouraged to perform sessions of cognitive training 3 times per week (30 minutes/session). Two of these sessions will involve computer or tablet-based attentional control training targeting dual-tasking, updating and working memory, as well as inhibition and switching. Difficulty of cognitive training will be tailored to participants' performances. The remaining session will consist of memory training. Participants will be instructed different mnemotechnic, as well as be taught about memory in aging in general. The memory training will be provided by videos capsules. To track adherence to cognitive training, participants will be asked to complete a journal and mark days and times where they took part in the various cognitive training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Multidomain intervention | Experimental | The multidomain intervention will combine a remote monitoring of home-based cognitive training with physical exercise training for 6-month. Receives: Other: Physical exercise training; Other: Cognitive training |
| Physical exercise intervention | Experimental | The physical exercises intervention will include the remote monitoring of physical exercise training for 6-month. Receives: Other: Physical exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in general cognitive functioning
Validated remote version of Montreal Cognitive Assessment (0-28 score, with a higher score indicating a better cognitive functioning).
Measured: Baseline and post-intervention at 6 months.
Change in executive functions
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Measured: Baseline and post-intervention at 6 months.
Change in processing speed
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Measured: Baseline and post-intervention at 6 months.
Change in episodic memory
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Measured: Baseline and post-intervention at 6 months.
Secondary outcomes (5)
Change in Walking speed
4-meter walking test (m/s).
Measured: Baseline and post-intervention at 6 months.
Change in Functional mobility
Timed up and Go test (s).
Measured: Baseline and post-intervention at 6 months.
Change in Balance performance
Timed one-leg standing test (s).
Measured: Baseline and post-intervention at 6 months.
Change in Lower limb muscles strength
Timed Sit-to-Stand test (s).
Measured: Baseline and post-intervention at 6 months.
Change in Cardiorespiratory fitness
Matthews cardiorespiratory fitness questionnaire (the score is an estimation of individual VO2 max (ml.kg.min) and range from 15-50, with a higher score indicating a higher VO2max).
Measured: Baseline and post-intervention at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start18 May 2020
- Primary completion15 Oct 2021
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louis Bherer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Louis Bherer, Montreal Heart Institute
- Investigators
- Louis Bherer, PhD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635462
- Sponsor's protocol ID
- 2020-2785
- Acronym
- COVEPIC
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2020
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.
PubMed 32112714Jimenez-Pavon D, Carbonell-Baeza A, Lavie CJ. Physical exercise as therapy to fight against the mental and physical consequences of COVID-19 quarantine: Special focus in older people. Prog Cardiovasc Dis. 2020 May-Jun;63(3):386-388. doi: 10.1016/j.pcad.2020.03.009. Epub 2020 Mar 24. No abstract available.
PubMed 32220590Chen P, Mao L, Nassis GP, Harmer P, Ainsworth BE, Li F. Coronavirus disease (COVID-19): The need to maintain regular physical activity while taking precautions. J Sport Health Sci. 2020 Mar;9(2):103-104. doi: 10.1016/j.jshs.2020.02.001. Epub 2020 Feb 4. No abstract available.
PubMed 32099716Bherer L, Erickson KI, Liu-Ambrose T. A review of the effects of physical activity and exercise on cognitive and brain functions in older adults. J Aging Res. 2013;2013:657508. doi: 10.1155/2013/657508. Epub 2013 Sep 11.
PubMed 24102028Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.
PubMed 12661673Bherer L. Cognitive plasticity in older adults: effects of cognitive training and physical exercise. Ann N Y Acad Sci. 2015 Mar;1337:1-6. doi: 10.1111/nyas.12682.
PubMed 25773610Dupuy O, Gauthier CJ, Fraser SA, Desjardins-Crepeau L, Desjardins M, Mekary S, Lesage F, Hoge RD, Pouliot P, Bherer L. Higher levels of cardiovascular fitness are associated with better executive function and prefrontal oxygenation in younger and older women. Front Hum Neurosci. 2015 Feb 18;9:66. doi: 10.3389/fnhum.2015.00066. eCollection 2015.
PubMed 25741267Renaud M, Bherer L, Maquestiaux F. A high level of physical fitness is associated with more efficient response preparation in older adults. J Gerontol B Psychol Sci Soc Sci. 2010 May;65B(3):317-22. doi: 10.1093/geronb/gbq004. Epub 2010 Feb 5.
PubMed 20139133Predovan D, Fraser SA, Renaud M, Bherer L. The effect of three months of aerobic training on stroop performance in older adults. J Aging Res. 2012;2012:269815. doi: 10.1155/2012/269815. Epub 2012 Dec 11.
PubMed 23304504Renaud M, Maquestiaux F, Joncas S, Kergoat MJ, Bherer L. The effect of three months of aerobic training on response preparation in older adults. Front Aging Neurosci. 2010 Nov 11;2:148. doi: 10.3389/fnagi.2010.00148. eCollection 2010.
PubMed 21151355Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.
PubMed 25405755Gross AL, Parisi JM, Spira AP, Kueider AM, Ko JY, Saczynski JS, Samus QM, Rebok GW. Memory training interventions for older adults: a meta-analysis. Aging Ment Health. 2012;16(6):722-34. doi: 10.1080/13607863.2012.667783.
PubMed 22423647Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271.
PubMed 12425704Bherer L, Kramer AF, Peterson MS, Colcombe S, Erickson K, Becic E. Training effects on dual-task performance: are there age-related differences in plasticity of attentional control? Psychol Aging. 2005 Dec;20(4):695-709. doi: 10.1037/0882-7974.20.4.695.
PubMed 16420143Lussier M, Gagnon C, Bherer L. An investigation of response and stimulus modality transfer effects after dual-task training in younger and older. Front Hum Neurosci. 2012 May 18;6:129. doi: 10.3389/fnhum.2012.00129. eCollection 2012.
PubMed 22629239
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cognitive and spOrt Virtual EPIC Training Study: INVESTIGATING THE EFFECTS OF HOME-BASED EXERCISE AND COGNITIVE TRAINING
- ClinicalTrials.gov ID
- NCT04635462
- Acronym / sponsor ID
- COVEPIC / 2020-2785
- Conditions
- Aging
- Keywords
- Aging, Remote monitoring, Home-based training, Cognitive Training, Physical Exercise, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Louis BhererUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 19 Nov 2020 (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 proposed COVEPIC trial is designed to document the effects of remote monitoring of physical exercise and home-based cognitive training on cognitive and physical functions in older adults.
Detailed description
Due to the actual pandemic of COVID-19 around the world, social distancing is recommended, which causes a reduction of social interaction and physical activity. Therefore, this health crisis may have collateral effects on cognitive, physical, and psychological health, especially in elderly people who are more likely to be isolated, and for whom social distancing is of paramount importance. Physical exercise practice has been demonstrated to improve cognitive functioning, along with mobility and physical capacity, and to promote psychological well-being. This is the reason why governmental health authorities, as well as the scientific community recommend to stay physically active, especially in this pandemic period. However, in the current context full-time physical training in sport centres cannot be largely promoted. Effective solutions to help older adults in maintaining regular and efficient physical exercise while maintaining social distancing, are thus needed. Consequently, the current project proposes first to investigate the potential of a remote monitoring of physical activity to promote cognitive, physical and psychological health of older adults. Also, considering the added benefits of combining cognitive training to physical exercise to further enhance health and cognition in seniors, this project also addresses the added benefits of a multidomain intervention combining a physical exercise intervention with a home-based cognitive training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidomain intervention | Experimental | Other: Physical exercise training, Other: Cognitive trainingThe multidomain intervention will combine a remote monitoring of home-based cognitive training with physical exercise training for 6-month. |
| Physical exercise intervention | Experimental | Other: Physical exercise trainingThe physical exercises intervention will include the remote monitoring of physical exercise training for 6-month. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult aged 50 and older
- Have access to internet
- Have access to a tablet (i.e. iPad or Android) or a computer
Key exclusion criteria (5 listed)
- Non-cardiopulmonary limitation to exercise (e.g., arthritis)
- Severe exercise intolerance
- Respiratory disease (e.g., asthma, COPD, COVID-19)
- Mini Mental Scale Examination (MMSE) telephone version lower than 19/23
- Diagnostic of cardiovascular disease (e.g., chronic systolic and diastolic heart failure, somatic aortic stenosis, atrial fibrillation, malignant arrhythmias, documented atherosclerotic disease).
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 |
|---|---|---|
| Physical exercise trainingParticipants will be encouraged to complete exercise training programs in the form of video capsules available via Facebook or Youtube, created by kinesiologists of the Montreal Heart Institut EPIC prevention center. The videos last about 15 minutes and include a warm-up of 3 to 5 minutes, followed a 10-minute training and finally a 2-minute cool-down period. The exercises on video do not require any equipment and integrate, depending on the video, aerobic, muscular strengthening, flexibility and/or balance exercises. Several intensities are described according to the participants' level. Participants will be invited to perform exercise sessions at least 5 times a week, and will be monitored weekly by phone by a member of the research team. The exercise sessions can be performed at home using the video training program, as well as in sports centre or outdoors. For each session, participants have to report its duration, intensity, and the nature of the activity via a follow-up agenda. | Other | Multidomain intervention, Physical exercise intervention |
| Cognitive trainingParticipants will be encouraged to perform sessions of cognitive training 3 times per week (30 minutes/session). Two of these sessions will involve computer or tablet-based attentional control training targeting dual-tasking, updating and working memory, as well as inhibition and switching. Difficulty of cognitive training will be tailored to participants' performances. The remaining session will consist of memory training. Participants will be instructed different mnemotechnic, as well as be taught about memory in aging in general. The memory training will be provided by videos capsules. To track adherence to cognitive training, participants will be asked to complete a journal and mark days and times where they took part in the various cognitive training sessions. | Other | Multidomain intervention |
Primary outcome
Change in general cognitive functioning
Time frame: Baseline and post-intervention at 6 months.
Validated remote version of Montreal Cognitive Assessment (0-28 score, with a higher score indicating a better cognitive functioning).
Change in executive functions
Time frame: Baseline and post-intervention at 6 months.
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in processing speed
Time frame: Baseline and post-intervention at 6 months.
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in episodic memory
Time frame: Baseline and post-intervention at 6 months.
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
5 secondary outcomes
Change in Walking speed
Time frame: Baseline and post-intervention at 6 months.
Change in Functional mobility
Time frame: Baseline and post-intervention at 6 months.
Change in Balance performance
Time frame: Baseline and post-intervention at 6 months.
Change in Lower limb muscles strength
Time frame: Baseline and post-intervention at 6 months.
Change in Cardiorespiratory fitness
Time frame: Baseline and post-intervention at 6 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 13 Nov 2023.
- Background: PubMed 32112714Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.
- Background: PubMed 32220590Jimenez-Pavon D, Carbonell-Baeza A, Lavie CJ. Physical exercise as therapy to fight against the mental and physical consequences of COVID-19 quarantine: Special focus in older people. Prog Cardiovasc Dis. 2020 May-Jun;63(3):386-388. doi: 10.1016/j.pcad.2020.03.009. Epub 2020 Mar 24. No abstract available.
- Background: PubMed 32099716Chen P, Mao L, Nassis GP, Harmer P, Ainsworth BE, Li F. Coronavirus disease (COVID-19): The need to maintain regular physical activity while taking precautions. J Sport Health Sci. 2020 Mar;9(2):103-104. doi: 10.1016/j.jshs.2020.02.001. Epub 2020 Feb 4. No abstract available.
- Background: PubMed 24102028Bherer L, Erickson KI, Liu-Ambrose T. A review of the effects of physical activity and exercise on cognitive and brain functions in older adults. J Aging Res. 2013;2013:657508. doi: 10.1155/2013/657508. Epub 2013 Sep 11.
- Background: PubMed 12661673Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.
- Background: PubMed 25773610Bherer L. Cognitive plasticity in older adults: effects of cognitive training and physical exercise. Ann N Y Acad Sci. 2015 Mar;1337:1-6. doi: 10.1111/nyas.12682.
- Background: PubMed 25741267Dupuy O, Gauthier CJ, Fraser SA, Desjardins-Crepeau L, Desjardins M, Mekary S, Lesage F, Hoge RD, Pouliot P, Bherer L. Higher levels of cardiovascular fitness are associated with better executive function and prefrontal oxygenation in younger and older women. Front Hum Neurosci. 2015 Feb 18;9:66. doi: 10.3389/fnhum.2015.00066. eCollection 2015.
- Background: PubMed 20139133Renaud M, Bherer L, Maquestiaux F. A high level of physical fitness is associated with more efficient response preparation in older adults. J Gerontol B Psychol Sci Soc Sci. 2010 May;65B(3):317-22. doi: 10.1093/geronb/gbq004. Epub 2010 Feb 5.
- Background: PubMed 23304504Predovan D, Fraser SA, Renaud M, Bherer L. The effect of three months of aerobic training on stroop performance in older adults. J Aging Res. 2012;2012:269815. doi: 10.1155/2012/269815. Epub 2012 Dec 11.
- Background: PubMed 21151355Renaud M, Maquestiaux F, Joncas S, Kergoat MJ, Bherer L. The effect of three months of aerobic training on response preparation in older adults. Front Aging Neurosci. 2010 Nov 11;2:148. doi: 10.3389/fnagi.2010.00148. eCollection 2010.
- Background: PubMed 25405755Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.
- Background: PubMed 22423647Gross AL, Parisi JM, Spira AP, Kueider AM, Ko JY, Saczynski JS, Samus QM, Rebok GW. Memory training interventions for older adults: a meta-analysis. Aging Ment Health. 2012;16(6):722-34. doi: 10.1080/13607863.2012.667783.
- 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.
Louis Bherer, PhD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise training and Cognitive training in people with Aging, run by Louis Bherer 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 3 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 13 Nov 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 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?
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 general cognitive functioning (time frame: Baseline and post-intervention at 6 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 NCT04635462, which also lists 24 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 Nov 2023.