Alzheimer DiseaseNCT05383053
Evaluating the Efficacy of Artificial Intelligence-based Computer Aided Diagnosis Software That Assists in Determining Whether or Not to Conduct Amyloid PET for the Diagnosis of Alzheimer's Disease by Predicting Amyloid PET Positivity in Mild Cognitive Impairment Patients
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Neurozen Inc. at 1 site in South Korea.
Trial summary
Purpose of clinical trial; This clinical trial is designed to evaluate the effectiveness of 'NeuroAI' prediction accuracy compared to the amyloid PET test results by retrospectively collecting medical data of patients with mild cognitive impairment to evaluate the effectiveness of artificial intelligence-based brain… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- NeuroAI
- Type of treatment
- Medical device
- How many people
- 227 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jul 2022to 8 Sep 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Brain MR images (T1 weighted MRI+T2 FLAIR MRI) of patients who underwent clinical diagnosis for Mild Cognitive Impairment and performed amyloid PET tests for suspected Alzheimer's disease N=227 (10% moderate dropout rate considered; 118 Positive*, 109 Negative**) *Positive : Amyloid PET Positive **Negative : Amyloid PET Negative
Who may be able to join
- Brain MR images of image providers suitable for all of the following selection criteria may be registered in this clinical trial.
- Among those diagnosed with mild cognitive impairment (MCI) in accordance with the International Working Group on Mild Cognitive Impairment criteria, those aged 50 or older on the MRI scan date.
- Those who have undergone 3D configurable 3T MRI (brain T1 weighted MRI* and T2 FLAIR MRI**) tests.
- 40-slice 2D T1 MRI scan: Plane shall be photographed with sagittal hippocampus.
- 3-slice 2D T2-FLAIR MRI scan: Plane shall be taken by axial.
- FBB (F-18 Florbetaben) amyloid PET test for suspected Alzheimer's mild cognitive impairment is positive or negative.
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- ☞ Images diagnosed with clear cerebral matrix damage (e.g., brain tumor, cerebral infarction, brain damage, normal pressure hydrocephalus, encephalitis) or mild cognitive impairment caused by metabolic diseases cannot participate in this clinical trial.
- A person who has the following clinical information recorded.
- Date of birth (or full age), gender, APOE genotype, mild cognitive impairment diagnosis date, mild cognitive impairment causative disease (Alzheimers, vascular, Louise, Parkinson's disease, frontal lobe, cerebral tumor, cerebral infarction, normal pressure head disease, encephalitis, unknown, other), MRI scan day, amyloid PET test*, FBB PET-BAPL score However, for FBB PET BAPL score, you may participate in this clinical trial even if the information is not recorded.
Who cannot join
- Brain MR images of image providers that fall under any of the following exclusion criteria cannot be registered in this clinical trial.
- MR images already used as training sets or validation sets for developing medical devices for clinical trials.
- ☞Chonnam National University Hospital and Chosun University Hospital use images not included in GARD cohort.
- If the interval between the date of diagnosis of mild cognitive impairment and the date of MRI scan/amyloid PET examination exceeds 2 years.
- If the tester determines that participation in the clinical trial is inappropriate because it may affect other, ethical or clinical trial results.
- Specific reasons shall be stated in the case record.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Artificial Intelligence-based Computer Aided Diagnosis Software That Assists in Determining Whether or Not to Conduct Amyloid PET for the Diagnosis of Alzheimer's Disease by Predicting Amyloid PET Positivity Using MR Brain Images(Including T1 Weighted MRI and T2 FLAIR MRI) and Clinical Information (Age, Sex, APOE(apolipoproteinE) Genotype) in Mild Cognitive Impairment Patients
- Purpose of clinical trial; This clinical trial is designed to evaluate the effectiveness of 'NeuroAI' prediction accuracy compared to the amyloid PET test results by retrospectively collecting medical data of patients with mild cognitive impairment to evaluate the effectiveness of artificial intelligence-based brain image detection and diagnosis assistance software 'NeuroAI'.
- Participants; Patient with mild cognitive impairment
Read the detailed description
- Clinical recruitment; Brain MR images (T1 weighted MRI+T2 FLAIR MRI) of patients who underwent clinical diagnosis for mild cognitive impairment and performed amyloid PET tests for suspected Alzheimer's disease.
- Target number of images; Total 227 (median dropout rate considered 10%; Positive*118, Negative**109) *Positive: Amyloid PET Positive **Negative: Amyloid PET Negative
- Selection criteria; Brain MR images of image providers suitable for all of the following selection criteria may be registered in this clinical trial.
- Among those diagnosed with mild cognitive impairment (MCI) in accordance with the International Working Group on Mild Cognitive Impairment criteria, those aged 50 or older on the MRI scan date.
- Those who have undergone 3D configurable 3T MRI (brain T1 weighted MRI* and T2 FLAIR MRI**) tests.
- 40-slice 2D T1 MRI scan: Plane shall be photographed with sagittal hippocampus. ** 3-slice 2D T2-FLAIR MRI scan: Plane shall be taken by axial.
- FBB (F-18 Florbetaben) amyloid PET test for suspected Alzheimer's mild cognitive impairment is positive or negative. ☞ Images diagnosed with clear cerebral matrix damage (e.g., brain tumor, cerebral infarction, brain damage, normal pressure hydrocephalus, encephalitis) or mild cognitive impairment caused by metabolic diseases cannot participate in this clinical trial.
- A person who has the following clinical information* recorded. *Date of birth (or full age), gender, APOE genotype, mild cognitive impairment diagnosis date, mild cognitive impairment causative disease (Alzheimers, vascular, Louise, Parkinson's disease, frontal lobe, cerebral tumor, cerebral infarction, normal pressure head disease, encephalitis, unknown, other), MRI scan day, amyloid PET test*, FBB PET-BAPL score However, for FBB PET BAPL score, you may participate in this clinical trial even if the information is not recorded.
- Exclusion criteria; Brain MR images of image providers that fall under any of the following exclusion criteria cannot be registered in this clinical trial.
- MR images already used as training sets or validation sets for developing medical devices for clinical trials.
- Chonnam National University Hospital and Chosun University Hospital use images not included in GARD cohort.
- If the interval between the date of diagnosis of mild cognitive impairment and the date of MRI scan/amyloid PET examination exceeds 2 years.
- If the tester determines that participation in the clinical trial is inappropriate because it may affect other, ethical or clinical trial results.
- Specific reasons shall be stated in the case record.
- Clinical trial method;
- Medical data of patients with mild cognitive impairment (brain MR images (T1 weighted MRI+T2 FLAIR MRI) and clinical information**) are continuously collected at Chosun University Hospital and Chonnam National University Hospital. However, the data used for NeuroAI learning is not collected. ☞ When moving medical data at Chosun University Hospital, an external hard drive with permission set so that only the tester can access it is used and delivered directly to the tester without using mail or other means. *Anonymization: permanently deleting personal identification information or replacing all or part of the personal identification information with the unique identification symbol of the organization. **Clinical information: Date of birth (or full age), gender, education level, APOE genotype, mild cognitive impairment diagnostic date, mild cognitive impairment causative disease (Alzheimers, vascular, Louise, Parkinson's disease, frontal lobe, brain tumor, cerebral infarction, normal hydrocephalus, unknown, other test days (PET).
- The collected medical data is stored in the NAS server built in the data center of Chonnam National University Hospital, a clinical trial institution. In this case, access rights should be set so that third parties other than the tester cannot access medical data.
- When medical data collection is completed, the tester checks whether the selection/exclusion criteria are met. Only brain MR images of image providers that meet all selection/exclusion criteria are enrolled in this clinical trial.
- When all images are registered, the tester releases the envelope containing the random array table and gives each image a random array number according to the random array table. The release of envelopes should be implemented immediately prior to the delivery of images to clinical trial medical care managers.
- A random arrangement table is generated by a statistician in charge of a random arrangement, sealed in an envelope, and delivered to the tester.
- The tester who released the envelope shall manage the random arrangement table not to be disclosed to others during the clinical trial period.
- The tester shall deliver to the clinical trial medical care manager a document containing MR images with random arrangement numbers and clinical information (birth year, gender, APOE genotype, MRI date) required for application of clinical trial medical devices. ☞ The images and documents delivered to the clinical trial medical care manager are blindfolded so that they do not include any information other than random arrangement numbers and clinical information entered into the clinical trial medical device.
- The clinical trial medical device manager checks the amyloid PET positive prediction information using the clinical trial medical device. After completing the confirmation of predictive information on the last image, the clinical trial medical manager extracts and collects the predictive information of all registered images in the form of a database, and delivers it to the data manager. ☞ During the clinical trial period, other test personnel other than medical care managers set access to the data so that predictive information of medical devices for clinical trials cannot be viewed.
- For all images, the clinical trial ends when the clinical information and predictive information of the medical device for clinical trial are collected.
- Clinical efficacy evaluation variable;
- First Clinical efficacy Assessment; Clinical Sensitivity(%), Clinical Specificity(%)
- Secondary Clinical efficacy Assessment; AUC of ROC Curve (Area Under the Curve of Receiver Operating Characteristic Curve), Accuracy(%)
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- NeuroAI
- Keywords
- Predicting Amyloid PET Positivity
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroAIDevice
NeuroAI is an artificial brain diagnostic software that determines whether to perform amyloid PET tests for Alzheimer's by specialists through the detection of amyloid PET positive rates based on brain MR images (T1 weighted MRI, T2 FLAIR MRI) and clinical information (age, gender, and APOE) genotype.
When using this product, input gender, birth year, and apolipoproteinE (APOE) genotype and upload T1 MR image and T2 Flair image, input data and image analysis result data are integrated to infer the positive rate of amyloid PET by PET positive prediction model. The result report provides image analysis results and amyloid PET positive prediction results compared to normal groups.
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore predictive values(Clinical Sensitivity, %)
Clinical efficacy evaluation of the probability of predicting 'NeuroAI' as positive amyloid PET phase for MR images of positive factors as a result of amyloid PET test
Measured: Jun-2022 until Dec-2022
Explore predictive values(Clinical Specificity, %)
Clinical efficacy evaluation of the probability that 'NeuroAI' does not predict positive amyloid PET phase for MR images of negative factors as a result of amyloid PET test
Measured: Jun-2022 until Dec-2022
Secondary outcomes (2)
Explore predictive values(AUC of ROC Curve (Area Under the Curve of Receiver Operating Characteristic Curve))
Clinical efficacy evaluation of the area below the ROC graph using the sensitivity (Y-axis) and false positive prediction (1-specificity, X-axis) of amyloid PET positive prediction presented by NeuroAI compared to the amyloid PET test results
Measured: Jun-2022 until Dec-2022
Explore predictive values(Accuracy, %)
Clinical efficacy evaluation of the probability that the amyloid PET test results and the prediction information on the amyloid PET of 'NeuroAI' match
Measured: Jun-2022 until Dec-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start22 Jul 2022
- Primary completion10 Aug 2022
- Study completion8 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurozen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chonnam National University Hospital, Chosun University Hospital
- Responsible party
- Sponsor
- Investigators
- Byeong Chae Kim, MD, Study chair, Professor (Department of Neurology,Chonnam National University Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383053
- Sponsor's protocol ID
- CNUH-2022-108
- Status last verified
- Sep 2022
- First submitted
- 16 May 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Artificial Intelligence-based Computer Aided Diagnosis Software That Assists in Determining Whether or Not to Conduct Amyloid PET for the Diagnosis of Alzheimer's Disease by Predicting Amyloid PET Positivity Using MR Brain Images(Including T1 Weighted MRI and T2 FLAIR MRI) and Clinical Information (Age, Sex, APOE(apolipoproteinE) Genotype) in Mild Cognitive Impairment Patients
- ClinicalTrials.gov ID
- NCT05383053
- Acronym / sponsor ID
- CNUH-2022-108
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Predicting Amyloid PET Positivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Neurozen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Chonnam National University Hospital, Chosun University Hospital
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Purpose of clinical trial; This clinical trial is designed to evaluate the effectiveness of 'NeuroAI' prediction accuracy compared to the amyloid PET test results by retrospectively collecting medical data of patients with mild cognitive impairment to evaluate the effectiveness of artificial intelligence-based brain image detection and diagnosis assistance software 'NeuroAI'.
- Participants; Patient with mild cognitive impairment
Detailed description
- Clinical recruitment; Brain MR images (T1 weighted MRI+T2 FLAIR MRI) of patients who underwent clinical diagnosis for mild cognitive impairment and performed amyloid PET tests for suspected Alzheimer's disease.
- Target number of images; Total 227 (median dropout rate considered 10%; Positive*118, Negative**109) *Positive: Amyloid PET Positive **Negative: Amyloid PET Negative
- Selection criteria; Brain MR images of image providers suitable for all of the following selection criteria may be registered in this clinical trial.
- Among those diagnosed with mild cognitive impairment (MCI) in accordance with the International Working Group on Mild Cognitive Impairment criteria, those aged 50 or older on the MRI scan date.
- Those who have undergone 3D configurable 3T MRI (brain T1 weighted MRI* and T2 FLAIR MRI**) tests.
- 40-slice 2D T1 MRI scan: Plane shall be photographed with sagittal hippocampus. ** 3-slice 2D T2-FLAIR MRI scan: Plane shall be taken by axial.
- FBB (F-18 Florbetaben) amyloid PET test for suspected Alzheimer's mild cognitive impairment is positive or negative. ☞ Images diagnosed with clear cerebral matrix damage (e.g., brain tumor, cerebral infarction, brain damage, normal pressure hydrocephalus, encephalitis) or mild cognitive impairment caused by metabolic diseases cannot participate in this clinical trial.
- A person who has the following clinical information* recorded. *Date of birth (or full age), gender, APOE genotype, mild cognitive impairment diagnosis date, mild cognitive impairment causative disease (Alzheimers, vascular, Louise, Parkinson's disease, frontal lobe, cerebral tumor, cerebral infarction, normal pressure head disease, encephalitis, unknown, other), MRI scan day, amyloid PET test*, FBB PET-BAPL score However, for FBB PET BAPL score, you may participate in this clinical trial even if the information is not recorded.
- Exclusion criteria; Brain MR images of image providers that fall under any of the following exclusion criteria cannot be registered in this clinical trial.
- MR images already used as training sets or validation sets for developing medical devices for clinical trials.
- Chonnam National University Hospital and Chosun University Hospital use images not included in GARD cohort.
- If the interval between the date of diagnosis of mild cognitive impairment and the date of MRI scan/amyloid PET examination exceeds 2 years.
- If the tester determines that participation in the clinical trial is inappropriate because it may affect other, ethical or clinical trial results.
- Specific reasons shall be stated in the case record.
- Clinical trial method;
- Medical data of patients with mild cognitive impairment (brain MR images (T1 weighted MRI+T2 FLAIR MRI) and clinical information**) are continuously collected at Chosun University Hospital and Chonnam National University Hospital. However, the data used for NeuroAI learning is not collected. ☞ When moving medical data at Chosun University Hospital, an external hard drive with permission set so that only the tester can access it is used and delivered directly to the tester without using mail or other means. *Anonymization: permanently deleting personal identification information or replacing all or part of the personal identification information with the unique identification symbol of the organization. **Clinical information: Date of birth (or full age), gender, education level, APOE genotype, mild cognitive impairment diagnostic date, mild cognitive impairment causative disease (Alzheimers, vascular, Louise, Parkinson's disease, frontal lobe, brain tumor, cerebral infarction, normal hydrocephalus, unknown, other test days (PET).
- The collected medical data is stored in the NAS server built in the data center of Chonnam National University Hospital, a clinical trial institution. In this case, access rights should be set so that third parties other than the tester cannot access medical data.
- When medical data collection is completed, the tester checks whether the selection/exclusion criteria are met. Only brain MR images of image providers that meet all selection/exclusion criteria are enrolled in this clinical trial.
- When all images are registered, the tester releases the envelope containing the random array table and gives each image a random array number according to the random array table. The release of envelopes should be implemented immediately prior to the delivery of images to clinical trial medical care managers.
- A random arrangement table is generated by a statistician in charge of a random arrangement, sealed in an envelope, and delivered to the tester.
- The tester who released the envelope shall manage the random arrangement table not to be disclosed to others during the clinical trial period.
- The tester shall deliver to the clinical trial medical care manager a document containing MR images with random arrangement numbers and clinical information (birth year, gender, APOE genotype, MRI date) required for application of clinical trial medical devices. ☞ The images and documents delivered to the clinical trial medical care manager are blindfolded so that they do not include any information other than random arrangement numbers and clinical information entered into the clinical trial medical device.
- The clinical trial medical device manager checks the amyloid PET positive prediction information using the clinical trial medical device. After completing the confirmation of predictive information on the last image, the clinical trial medical manager extracts and collects the predictive information of all registered images in the form of a database, and delivers it to the data manager. ☞ During the clinical trial period, other test personnel other than medical care managers set access to the data so that predictive information of medical devices for clinical trials cannot be viewed.
- For all images, the clinical trial ends when the clinical information and predictive information of the medical device for clinical trial are collected.
- Clinical efficacy evaluation variable;
- First Clinical efficacy Assessment; Clinical Sensitivity(%), Clinical Specificity(%)
- Secondary Clinical efficacy Assessment; AUC of ROC Curve (Area Under the Curve of Receiver Operating Characteristic Curve), Accuracy(%)
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Brain MR images (T1 weighted MRI+T2 FLAIR MRI) of patients who underwent clinical diagnosis for Mild Cognitive Impairment and performed amyloid PET tests for suspected Alzheimer's disease N=227 (10% moderate dropout rate considered; 118 Positive*, 109 Negative**) *Positive : Amyloid PET Positive **Negative : Amyloid PET Negative
Key inclusion criteria (9 listed)
- Brain MR images of image providers suitable for all of the following selection criteria may be registered in this clinical trial.
- 3-slice 2D T2-FLAIR MRI scan: Plane shall be taken by axial.
- ☞ Images diagnosed with clear cerebral matrix damage (e.g., brain tumor, cerebral infarction, brain damage, normal pressure hydrocephalus, encephalitis) or mild cognitive impairment caused by metabolic diseases cannot participate in this clinical trial.
Key exclusion criteria (6 listed)
- Brain MR images of image providers that fall under any of the following exclusion criteria cannot be registered in this clinical trial.
- ☞Chonnam National University Hospital and Chosun University Hospital use images not included in GARD cohort.
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 |
|---|---|---|
| NeuroAINeuroAI is an artificial brain diagnostic software that determines whether to perform amyloid PET tests for Alzheimer's by specialists through the detection of amyloid PET positive rates based on brain MR images (T1 weighted MRI, T2 FLAIR MRI) and clinical information (age, gender, and APOE) genotype. When using this product, input gender, birth year, and apolipoproteinE (APOE) genotype and upload T1 MR image and T2 Flair image, input data and image analysis result data are integrated to infer the positive rate of amyloid PET by PET positive prediction model. The result report provides image analysis results and amyloid PET positive prediction results compared to normal groups. | Device | – |
Primary outcome
Explore predictive values(Clinical Sensitivity, %)
Time frame: Jun-2022 until Dec-2022
Clinical efficacy evaluation of the probability of predicting 'NeuroAI' as positive amyloid PET phase for MR images of positive factors as a result of amyloid PET test
Explore predictive values(Clinical Specificity, %)
Time frame: Jun-2022 until Dec-2022
Clinical efficacy evaluation of the probability that 'NeuroAI' does not predict positive amyloid PET phase for MR images of negative factors as a result of amyloid PET test
2 secondary outcomes
Explore predictive values(AUC of ROC Curve (Area Under the Curve of Receiver Operating Characteristic Curve))
Time frame: Jun-2022 until Dec-2022
Explore predictive values(Accuracy, %)
Time frame: Jun-2022 until Dec-2022
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 16 Sep 2022.
- 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.
Byeong Chae Kim, MD study chair
Professor (Department of Neurology,Chonnam National University Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Neurozen Inc. at 1 site in South Korea.
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 9 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: finished, as of the sponsor's last update on 16 Sep 2022. 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 South Korea. 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?
Explore predictive values(Clinical Sensitivity, %) (time frame: Jun-2022 until Dec-2022). The study lists 2 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 16 Sep 2022.