Mild Cognitive ImpairmentSMARTNCT04913857

Effects of SUDOKU Mind Activation & Revitalizing Training on Cognitive Function in People With Mild Cognitive Impairment

A study testing 24-week SUDOKU Training Programme in people with Mild Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 55 years and older
Conditions the study is for: Mild Cognitive Impairment
What is being tested?: 24-week SUDOKU Training Programme
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 262 participants
Where: 1 siteHong Kong
Study dates: 15 Sep 2020to 31 Dec 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 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

People with MCI as defined by a score of 19-26 out of the 30 on the Montreal Cognitive Assessment in the general public and aged 55 or above.

Who cannot join

Persons with dementia and communication problems will be excluded.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Department of Medicine and Geriatrics, United Christian Hospital
Hong Kong

Other trials in Hong Kong

About this study

Official title: New Wine in Old Bottle: the Effects of SUDOKU Mind Activation and Revitalizing Training (SMART) Program on Cognitive Function Among People With Mild Cognitive Impairment

This study aims to implement a SUDOKU Mind Activation and Revitalization Training (SMART) Program to promote cognitive health among patients with mild cognitive impairment (MCI), and the use of active mind strategy in preventing dementia among the older adults. The SMART Program consists of two components including, a community empowerment-educational campaign on active mind strategies for older adults, and a 24-week SUDOKU Training Programme for people with MCI.

Read the detailed description

This study aims to implement a SMART Program to promote cognitive health among patients with MCI, and the use of active mind strategy in preventing dementia among the older adults. The SMART Program consists of two components including, a community empowerment-educational campaign on active mind strategies for older adults, and a 24-week SUDOKU Training Programme for people with MCI.

The community empowerment-educational campaign will be conducted in the elderly care centres of the two collaborating non-governmental organizations, with the purpose of increasing the awareness of people aged 55 or above on the importance of maintaining an active mind and preventing age-related cognitive decline and dementia. The campaign will include cognitive screening, poster exhibition, booth exhibition and individual counselling.

The SUDOKU training program include a 12-week face-to-face training session and a 12-week facilitated self-practice. The face-to-face sessions aim at developing the skills of the participants in solving the SUDOKU using the T-code. The 12-week training program will be evenly divided into three modules of increasing difficulty, with consideration given to the suboptimal cognitive function of the participants with MCI. These modules are developed by the Co-investigator who has rich prior experience in teaching older adults on SUDOKU puzzle.

Conditions: Mild Cognitive Impairment
Being tested: 24-week SUDOKU Training Programme, Control Arm (wait-list)
Keywords: Mild Cognitive Impairment
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

24-week SUDOKU Training ProgrammeBehavioural
Also called SMART
12-week face-to-face training session and a 12-week facilitated self-practice
Control Arm (wait-list)Other
wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes

Study groups in NCT04913857
Study group	Role	What they receive
24-week SUDOKU Training Programme	Experimental	The SUDOKU training program include a 12-week face-to-face training session and a 12-week facilitated self-practice. The 12-week (60-minute sessions) training program will be evenly divided into 3 modules of increasing difficulty for the suboptimal cognitive function of the participants with MCI. As the use of T-code in solving the SUDOKU allows communicating the way a number is assigned to a box, participants are grouped into a small team of 3, so that they will work together during the tutorial practice. Facilitated self-practice will last for another 12 weeks immediately after the group training session. The instructor will give them a workbook with 12 SUDOKU puzzles of increasing level of difficulty for completion. The instructor will encourage and facilitate their accomplishment by giving them guidance on the taught method through regular phone call. Solutions of the assigned puzzle and the T-code will be provided in the following week. Receives: Behavioral: 24-week SUDOKU Training Programme
wait-list	Active comparator	wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes Receives: Other: Control Arm (wait-list)

What is being measured

The primary outcome is the main question the study is designed to answer.

Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
To evaluate various domains of cognition
Measured: Baseline
Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
To evaluate various domains of cognition
Measured: 12-week
Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
To evaluate various domains of cognition
Measured: 24-week
The digit span-forward and backward test
To measure attention and working memory
Measured: Baseline
The digit span-forward and backward test
To measure attention and working memory
Measured: 12-week
The digit span-forward and backward test
To measure attention and working memory
Measured: 24-week
The list learning delayed recall test
To measure episodic memory
Measured: Baseline
The list learning delayed recall test
To measure episodic memory
Measured: 12-week
The list learning delayed recall test
To measure episodic memory
Measured: 24-week
Trail-Making Test Part A and B
To measure complex attention, executive function and task switching
Measured: Baseline
Trail-Making Test Part A and B
To measure complex attention, executive function and task switching
Measured: 12-week
Trail-Making Test Part A and B
To measure complex attention, executive function and task switching
Measured: 24-week

Secondary outcomes (5)

Memory Inventory for Chinese
To evaluate the subjective memory impairment
Measured: Baseline
Memory Inventory for Chinese
To evaluate the subjective memory impairment
Measured: 12-week
Memory Inventory for Chinese
To evaluate the subjective memory impairment
Measured: 24-week
The 36-item Chinese version of the Short Form 36 (SF-36)
To measure Health-related quality of life in the participants
Measured: Baseline
The 36-item Chinese version of the Short Form 36 (SF-36)
To measure Health-related quality of life in the participants
Measured: 24-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202031 Dec 2023

First posted4 Jun 2021
Study start15 Sep 2020
Primary completion31 Oct 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by The University of Hong KongThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: To implement a SMART Program to promote cognitive health among patients with MCI, and the use of active mind strategy in preventing dementia among the older adults
Masking: None (open label)
Enrolment: 262 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04913857
Sponsor's protocol ID: SMART
Acronym: SMART
Status last verified: Jan 2024
First submitted: 16 Apr 2021
Last updated: 9 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Only study investigators and research assistants involved in the study will have access to the data.

Publications

Wu YT, Lee HY, Norton S, Chen C, Chen H, He C, Fleming J, Matthews FE, Brayne C. Prevalence studies of dementia in mainland china, Hong Kong and taiwan: a systematic review and meta-analysis. PLoS One. 2013 Jun 11;8(6):e66252. doi: 10.1371/journal.pone.0066252. Print 2013.
PubMed 23776645
Lam LC, Tam CW, Lui VW, Chan WC, Chan SS, Wong S, Wong A, Tham MK, Ho KS, Chan WM, Chiu HF. Prevalence of very mild and mild dementia in community-dwelling older Chinese people in Hong Kong. Int Psychogeriatr. 2008 Feb;20(1):135-48. doi: 10.1017/S1041610207006199. Epub 2007 Sep 25.
PubMed 17892609
Ding D, Zhao Q, Guo Q, Liang X, Luo J, Yu L, Zheng L, Hong Z; Shanghai Aging Study (SAS). Progression and predictors of mild cognitive impairment in Chinese elderly: A prospective follow-up in the Shanghai Aging Study. Alzheimers Dement (Amst). 2016 Apr 9;4:28-36. doi: 10.1016/j.dadm.2016.03.004. eCollection 2016.
PubMed 27489876
Wirth M, Haase CM, Villeneuve S, Vogel J, Jagust WJ. Neuroprotective pathways: lifestyle activity, brain pathology, and cognition in cognitively normal older adults. Neurobiol Aging. 2014 Aug;35(8):1873-82. doi: 10.1016/j.neurobiolaging.2014.02.015. Epub 2014 Feb 20.
PubMed 24656834
Reuter-Lorenz PA, Park DC. How does it STAC up? Revisiting the scaffolding theory of aging and cognition. Neuropsychol Rev. 2014 Sep;24(3):355-70. doi: 10.1007/s11065-014-9270-9. Epub 2014 Aug 21.
PubMed 25143069
Sherman DS, Mauser J, Nuno M, Sherzai D. The Efficacy of Cognitive Intervention in Mild Cognitive Impairment (MCI): a Meta-Analysis of Outcomes on Neuropsychological Measures. Neuropsychol Rev. 2017 Dec;27(4):440-484. doi: 10.1007/s11065-017-9363-3. Epub 2017 Dec 27.
PubMed 29282641
Tardif S, Simard M. Cognitive stimulation programs in healthy elderly: a review. Int J Alzheimers Dis. 2011;2011:378934. doi: 10.4061/2011/378934. Epub 2011 Aug 15.
PubMed 21876829
Brooker H, Wesnes KA, Ballard C, Hampshire A, Aarsland D, Khan Z, Stenton R, McCambridge L, Corbett A. An online investigation of the relationship between the frequency of word puzzle use and cognitive function in a large sample of older adults. Int J Geriatr Psychiatry. 2019 Jul;34(7):921-931. doi: 10.1002/gps.5033. Epub 2019 May 16.
PubMed 30443984
Schultz SA, Larson J, Oh J, Koscik R, Dowling MN, Gallagher CL, Carlsson CM, Rowley HA, Bendlin BB, Asthana S, Hermann BP, Johnson SC, Sager M, LaRue A, Okonkwo OC. Participation in cognitively-stimulating activities is associated with brain structure and cognitive function in preclinical Alzheimer's disease. Brain Imaging Behav. 2015 Dec;9(4):729-36. doi: 10.1007/s11682-014-9329-5.
PubMed 25358750
Pillai JA, Hall CB, Dickson DW, Buschke H, Lipton RB, Verghese J. Association of crossword puzzle participation with memory decline in persons who develop dementia. J Int Neuropsychol Soc. 2011 Nov;17(6):1006-13. doi: 10.1017/S1355617711001111.
PubMed 22040899
Ferreira N, Owen A, Mohan A, Corbett A, Ballard C. Associations between cognitively stimulating leisure activities, cognitive function and age-related cognitive decline. Int J Geriatr Psychiatry. 2015 Apr;30(4):422-30. doi: 10.1002/gps.4155. Epub 2014 Jul 3.
PubMed 24989949
Chu LW, Chiu KC, Hui SL, Yu GK, Tsui WJ, Lee PW. The reliability and validity of the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) among the elderly Chinese in Hong Kong. Ann Acad Med Singap. 2000 Jul;29(4):474-85.
PubMed 11056778
Lui VW, Lam LC, Chiu HF. Validation of a memory inventory for the assessment of awareness of memory deficits in Alzheimer's disease in Chinese elderly. Int J Geriatr Psychiatry. 2006 Oct;21(10):917-23. doi: 10.1002/gps.1580.
PubMed 16927409
Lam CL, Gandek B, Ren XS, Chan MS. Tests of scaling assumptions and construct validity of the Chinese (HK) version of the SF-36 Health Survey. J Clin Epidemiol. 1998 Nov;51(11):1139-47. doi: 10.1016/s0895-4356(98)00105-x.
PubMed 9817131
Rabiee F. Focus-group interview and data analysis. Proc Nutr Soc. 2004 Nov;63(4):655-60. doi: 10.1079/pns2004399.
PubMed 15831139

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: New Wine in Old Bottle: the Effects of SUDOKU Mind Activation and Revitalizing Training (SMART) Program on Cognitive Function Among People With Mild Cognitive Impairment
ClinicalTrials.gov ID: NCT04913857
Acronym / sponsor ID: SMART / SMART
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Study type: Interventional
Recruitment status: Completed
Enrolment: 262 participants (actual)
Lead sponsor: The University of Hong KongUniversity, hospital or other
Study start: 15 Sep 2020 (actual)
Primary completion: 31 Oct 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 4 Jun 2021 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: To implement a SMART Program to promote cognitive health among patients with MCI, and the use of active mind strategy in preventing dementia among the older adults

Arm	Type	Receives
24-week SUDOKU Training Programme	Experimental	Behavioral: 24-week SUDOKU Training ProgrammeThe SUDOKU training program include a 12-week face-to-face training session and a 12-week facilitated self-practice. The 12-week (60-minute sessions) training program will be evenly divided into 3 modules of increasing difficulty for the suboptimal cognitive function of the participants with MCI. As the use of T-code in solving the SUDOKU allows communicating the way a number is assigned to a box, participants are grouped into a small team of 3, so that they will work together during the tutorial practice. Facilitated self-practice will last for another 12 weeks immediately after the group training session. The instructor will give them a workbook with 12 SUDOKU puzzles of increasing level of difficulty for completion. The instructor will encourage and facilitate their accomplishment by giving them guidance on the taught method through regular phone call. Solutions of the assigned puzzle and the T-code will be provided in the following week.
wait-list	Active comparator	Other: Control Arm (wait-list)wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

People with MCI as defined by a score of 19-26 out of the 30 on the Montreal Cognitive Assessment in the general public and aged 55 or above.

Key exclusion criteria (1 listed)

Persons with dementia and communication problems will be excluded.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
24-week SUDOKU Training ProgrammeAlso: SMART12-week face-to-face training session and a 12-week facilitated self-practice	Behavioural	24-week SUDOKU Training Programme
Control Arm (wait-list)wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes	Other	wait-list

Primary outcome

Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Time frame: Baseline
To evaluate various domains of cognition
Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Time frame: 12-week
To evaluate various domains of cognition
Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Time frame: 24-week
To evaluate various domains of cognition
The digit span-forward and backward test
Time frame: Baseline
To measure attention and working memory
The digit span-forward and backward test
Time frame: 12-week
To measure attention and working memory
The digit span-forward and backward test
Time frame: 24-week
To measure attention and working memory
The list learning delayed recall test
Time frame: Baseline
To measure episodic memory
The list learning delayed recall test
Time frame: 12-week
To measure episodic memory
The list learning delayed recall test
Time frame: 24-week
To measure episodic memory
Trail-Making Test Part A and B
Time frame: Baseline
To measure complex attention, executive function and task switching
Trail-Making Test Part A and B
Time frame: 12-week
To measure complex attention, executive function and task switching
Trail-Making Test Part A and B
Time frame: 24-week
To measure complex attention, executive function and task switching

5 secondary outcomes

Memory Inventory for Chinese
Time frame: Baseline
Memory Inventory for Chinese
Time frame: 12-week
Memory Inventory for Chinese
Time frame: 24-week
The 36-item Chinese version of the Short Form 36 (SF-36)
Time frame: Baseline
The 36-item Chinese version of the Short Form 36 (SF-36)
Time frame: 24-week

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 9 Jan 2024.
Background: PubMed 23776645Wu YT, Lee HY, Norton S, Chen C, Chen H, He C, Fleming J, Matthews FE, Brayne C. Prevalence studies of dementia in mainland china, Hong Kong and taiwan: a systematic review and meta-analysis. PLoS One. 2013 Jun 11;8(6):e66252. doi: 10.1371/journal.pone.0066252. Print 2013.
Background: PubMed 17892609Lam LC, Tam CW, Lui VW, Chan WC, Chan SS, Wong S, Wong A, Tham MK, Ho KS, Chan WM, Chiu HF. Prevalence of very mild and mild dementia in community-dwelling older Chinese people in Hong Kong. Int Psychogeriatr. 2008 Feb;20(1):135-48. doi: 10.1017/S1041610207006199. Epub 2007 Sep 25.
Background: PubMed 27489876Ding D, Zhao Q, Guo Q, Liang X, Luo J, Yu L, Zheng L, Hong Z; Shanghai Aging Study (SAS). Progression and predictors of mild cognitive impairment in Chinese elderly: A prospective follow-up in the Shanghai Aging Study. Alzheimers Dement (Amst). 2016 Apr 9;4:28-36. doi: 10.1016/j.dadm.2016.03.004. eCollection 2016.
Background: PubMed 24656834Wirth M, Haase CM, Villeneuve S, Vogel J, Jagust WJ. Neuroprotective pathways: lifestyle activity, brain pathology, and cognition in cognitively normal older adults. Neurobiol Aging. 2014 Aug;35(8):1873-82. doi: 10.1016/j.neurobiolaging.2014.02.015. Epub 2014 Feb 20.
Background: PubMed 25143069Reuter-Lorenz PA, Park DC. How does it STAC up? Revisiting the scaffolding theory of aging and cognition. Neuropsychol Rev. 2014 Sep;24(3):355-70. doi: 10.1007/s11065-014-9270-9. Epub 2014 Aug 21.
Background: PubMed 29282641Sherman DS, Mauser J, Nuno M, Sherzai D. The Efficacy of Cognitive Intervention in Mild Cognitive Impairment (MCI): a Meta-Analysis of Outcomes on Neuropsychological Measures. Neuropsychol Rev. 2017 Dec;27(4):440-484. doi: 10.1007/s11065-017-9363-3. Epub 2017 Dec 27.
Background: PubMed 21876829Tardif S, Simard M. Cognitive stimulation programs in healthy elderly: a review. Int J Alzheimers Dis. 2011;2011:378934. doi: 10.4061/2011/378934. Epub 2011 Aug 15.
Background: PubMed 30443984Brooker H, Wesnes KA, Ballard C, Hampshire A, Aarsland D, Khan Z, Stenton R, McCambridge L, Corbett A. An online investigation of the relationship between the frequency of word puzzle use and cognitive function in a large sample of older adults. Int J Geriatr Psychiatry. 2019 Jul;34(7):921-931. doi: 10.1002/gps.5033. Epub 2019 May 16.
Background: PubMed 25358750Schultz SA, Larson J, Oh J, Koscik R, Dowling MN, Gallagher CL, Carlsson CM, Rowley HA, Bendlin BB, Asthana S, Hermann BP, Johnson SC, Sager M, LaRue A, Okonkwo OC. Participation in cognitively-stimulating activities is associated with brain structure and cognitive function in preclinical Alzheimer's disease. Brain Imaging Behav. 2015 Dec;9(4):729-36. doi: 10.1007/s11682-014-9329-5.
Background: PubMed 22040899Pillai JA, Hall CB, Dickson DW, Buschke H, Lipton RB, Verghese J. Association of crossword puzzle participation with memory decline in persons who develop dementia. J Int Neuropsychol Soc. 2011 Nov;17(6):1006-13. doi: 10.1017/S1355617711001111.
Background: PubMed 24989949Ferreira N, Owen A, Mohan A, Corbett A, Ballard C. Associations between cognitively stimulating leisure activities, cognitive function and age-related cognitive decline. Int J Geriatr Psychiatry. 2015 Apr;30(4):422-30. doi: 10.1002/gps.4155. Epub 2014 Jul 3.
Background: PubMed 11056778Chu LW, Chiu KC, Hui SL, Yu GK, Tsui WJ, Lee PW. The reliability and validity of the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) among the elderly Chinese in Hong Kong. Ann Acad Med Singap. 2000 Jul;29(4):474-85.
Global Council on Brain Health. "Engaging your brain: GCBH recommendations on cognitively stimulating activities."Link provided by the sponsor.
Lam J. Numbers add up for scores of seniors in Sudoku competition.Link provided by the sponsor.
Individual participant dataSharing planned: No. Only study investigators and research assistants involved in the study will have access to the data.

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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.

Doris, Sau Fung YU, PhD principal investigator

The University of Hong Kong

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 24-week SUDOKU Training Programme in people with Mild Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.

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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2024. 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 Hong Kong. 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?

Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) (time frame: Baseline). The study lists 12 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 NCT04913857, which also lists 15 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 9 Jan 2024.