Alzheimer DiseaseNCT05527288
A Bridging Study on Efficacy and Safety of [18F]Florbetaben PET for Diagnosis of Alzheimer Disease Subjects in Chinese Population
A study testing Drug: [18F]florbetaben in people with Alzheimer Disease and Dementia, run by Sinotau Pharmaceutical Group at 1 site in China.
Trial summary
This is a bridging study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with Alzheimer disease. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Brain Diseases
- What is being tested?
- Drug: [18F]florbetaben
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2021to 12 Sep 2021
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Inclusion criteria for non-cognitively impaired subjects:
- Male or female aged between 55 and 85 years old (including 55 and 85 years old);
- The education level of primary school or above, and can cooperate with the tests required for research including neuropsychological tests (cognitive ability, language ability, visual and auditory acuity can meet the requirements of the test);
- Be able to understand the purpose and experimental protocol of clinical research;
- The researcher judges that the subjects are in good health, and there is no abnormal or abnormality in the comprehensive physical examination, vital sign examination and laboratory examination, but they can participate in this bridging clinical trial according to the judgment of the clinician;
- Clinical dementia score (CDR) of 0, and the Mini-Mental State Examination Scale (MMSE score) of ≥28;
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- For women of potential fertility (not yet or within 2 years of menopause), effective contraceptive measures must be used during the study period and within 6 months after the end of the study (effective contraceptive measures refer to sterilization, intrauterine hormonal devices, contraception condoms, contraceptives/dose, abstinence or partner removal of the vas deferens, etc.); male subjects should agree to use contraceptives during the study period and within 6 months after the end of the study period;
- Able to sign the informed consent form.
- 2. Inclusion criteria for subjects with mild to moderate AD:
- Male or female aged between 55 and 85 years old (including 55 and 85 years old);
- The education level of primary school or above, and the ability to complete the cognitive ability test and other tests stipulated in the program;
- Diagnosed as probable AD according to NINCDS-ADRDA criteria;
- 18≤MMSE score≤26;
- CDR score of 0.5, 1 or 2;
- The investigator judges that the subject's "caregiver" can provide accurate information and report on the patient's cognitive and functional abilities;
- For women of potential fertility (not yet menopause or within 2 years of menopause), effective contraceptive measures must be used during the study period and within 6 months after the end of the study (effective contraceptive measures refer to sterilization, intrauterine hormonal devices, contraception condoms, contraceptives/dose, abstinence or partner removal of the vas deferens, etc.); male subjects should agree to use contraceptives during the study period and within 6 months after the end of the study period;
- Able to sign the informed consent form.
- 3. Inclusion criteria for healthy subjects:
- Male or female aged 18 to 40 years old (including 18 years old and 40 years old);
- Good health or no major diseases, as judged by the investigator based on the following evaluations: medical history, vital signs, physical examination, electrocardiogram and results of clinical laboratory tests;
- Not using any drugs;
- EEG examination, judged as "normal";
- Screening blood routine, blood biochemistry and urine routine are normal, or the abnormality has no clinical significance;
- Women must use effective contraceptive measures during the study period and within 6 months after the end of the study (effective contraceptive measures refer to sterilization, intrauterine hormone devices, condoms, contraceptives/agents, abstinence or partner removal of the vas deferens, etc.) ; male subjects should agree to use contraception during the study period and within 6 months after the end of the study period;
- Able to sign the informed consent form.
Who cannot join
- 1. Exclusion criteria for non-cognitively impaired subjects:
- History of various mental illnesses such as anxiety disorders, affective disorders, and schizophrenia;
- Depression Screening Scale (PHQ-9) of ≥ 5 points;
- Anxiety Disorder Screening Scale (GAD-7) of ≥ 5 points;
- Severe neurological diseases, such as cerebrovascular diseases, inflammatory or infectious diseases, or any metabolic encephalopathy, neurodegenerative diseases, including Parkinson's disease history or physical or imaging manifestations;
- History of severe craniocerebral injury, craniocerebral surgery or intracranial hematoma with permanent brain injury;
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- The results of cranial magnetic resonance imaging (MRI) also meet the following imaging findings: ①There are two or more infarcts outside the brain stem (diameter greater than 2 cm); ②Key parts such as thalamus, hippocampus, entorhinal cortex and angular gyrus Lacunar infarction; ③Fazekas score of high white matter damage ≥3;
- Brain MRI examination showed enlarged perivascular space with subcortical diameter >3mm in short axis;
- SWI (susceptibility-weighted imaging) prompts: cerebral microbleeds ≥5 locations;
- History of alcohol or drug abuse/dependence;
- Contraindications of MRI examination: such as heart pacemaker or nerve stimulator or metal foreign body, high fever, etc.;
- Invasive surgery is planned within one week after administration of the study drug;
- Allergy to the investigational drug or any of its components and/or a history of severe allergic reaction to the drug or allergens (such as allergic asthma);
- Any major disease or unstable disease state (such as unstable angina pectoris, myocardial infarction or coronary revascularization, heart failure, acute and chronic renal failure, chronic liver disease, severe lung disease, blood disease, poor blood sugar control, chronic infection in the past 2 years, received surgical treatment 7 days ago, advanced cardiac insufficiency (New York Heart Association (NYHA stage IV), etc.);
- History of tumor within 5 years (except cervical carcinoma in situ, prostate carcinoma in situ or local skin cancer after surgery);
- Human immunodeficiency virus (HIV), hepatitis C or Treponema pallidum antibody test positive, hepatitis B surface antigen positive (except hepatitis B carriers);
- Received drug therapy or other treatments (such as chemotherapy) that cause large fluctuations in hematological or biochemical indicators or serious side effects within two weeks before the screening examination;
- Receive any contrast agent or radiopharmaceutical within 48 hours before application of test drug, or will use contrast agent within 24 hours after administration of study drug;
- Participated in clinical research of other drugs within 30 days before enrollment or within 5 half-lives of the study drug (whichever is longer), and/or used any radiopharmaceuticals before the administration of the study drug, and not more than 10 radioactive half-lives apart;
- History of epilepsy;
- History of electroconvulsive therapy;
- Received medications that may affect cognition, such as anxiolytics, within 2 weeks prior to the screening exam, and a history of receiving antidepressants and/or antipsychotics;
- History of delirium (e.g. after surgery);
- Other investigators deem it inappropriate to participate in the trial.
- 2. Exclusion criteria for subjects with mild to moderate AD:
- History of various serious mental illnesses (such as severe depression, anxiety, affective disorders, schizophrenia or schizoaffective disorder) with PHQ-9 ≥ 10 points or GAD-7 ≥ 10 points;
- Epilepsy episode occurred within the past 1 year;
- Dementia caused by other reasons or cognitive dysfunction caused by other reasons: such as vascular dementia, Parkinson's disease dementia, Lewy body dementia, normal intracranial pressure hydrocephalus, intracranial mass, central nervous system infection (Such as HIV, syphilis, etc.), metabolic encephalopathy, etc.;
- The results of cranial MRI also meet the following imaging findings: ①There are more than two infarcts outside the brain stem (diameter greater than 2 cm); ②Lacunar infarction in key parts such as the thalamus, hippocampus, entorhinal cortex and angular gyrus ③The Fazekas score of high white matter damage ≥ 3;
- Brain MRI examination showed enlarged perivascular space with subcortical diameter >3mm in short axis;
- SWI prompt: cerebral microbleeds ≥5 locations;
- History of alcohol or drug abuse/dependence;
- Contraindications of MRI examination: such as heart pacemaker or nerve stimulator or metal foreign body, high fever, etc.;
- Subjects who plan to undergo surgery and/or other invasive surgery within 24 hours after the application of the trial drug;
- Allergy to the investigational drug or any of its components and/or history of severe allergic reaction to the drug or allergens (such as allergic asthma);
- Any major disease or unstable disease state (such as unstable angina pectoris, myocardial infarction or coronary revascularization, heart failure, acute and chronic renal failure, chronic liver disease, severe lung disease, blood Diabetic patients with disease, poor blood sugar control, chronic infection in the past 2 years, received surgical treatment 7 days ago, advanced cardiac insufficiency (NYHA stage IV), major depressive episode, etc.);
- History of tumor within 5 years (except cervical carcinoma in situ, prostate carcinoma in situ or local skin cancer after surgery);
- HIV, hepatitis C or Treponema pallidum antibody test positive, hepatitis B surface antigen positive (except hepatitis B carriers);
- History of physical examination or imaging examination of neurological diseases (such as severe cerebrovascular disease, inflammation, infectious diseases and degenerative diseases, etc.);
- History of severe craniocerebral injury, craniocerebral surgery or intracranial hematoma with permanent brain injury;
- Received drug therapy or other treatments (such as chemotherapy) that cause large fluctuations in hematological or biochemical indicators or serious side effects within two weeks before the screening examination;
- Receive any contrast agent or radiopharmaceutical within 48 hours before application of test drug, or will use contrast agent within 24 hours after administration of test drug;
- Participated in clinical research of other drugs within 30 days before enrollment or within 5 half-lives of the study drug (whichever is longer), and/or used any radiopharmaceuticals before the administration of the study drug, and not more than 10 radioactive half-lives apart;
- Other investigators deem it inappropriate to participate in the trial.
- 3. Exclusion criteria for healthy subjects:
- Any previous brain disease, such as cerebrovascular disease, inflammatory or infectious disease, or any neurodegenerative disease, including Parkinson's disease history or physical or imaging manifestations; history of traumatic brain injury or brain surgery or cranial Internal hematoma with a history of permanent brain injury;
- Any previous major disease or unstable condition (such as unstable angina pectoris, dilated or hypertrophic cardiomyopathy, valvular heart disease, congenital heart disease, myocardial infarction or coronary revascularization, heart failure, chronic renal failure, Chronic liver disease, severe lung disease, blood disease, diabetes, chronic infection, epilepsy, history of mental illness);
- Have used drugs in the past week;
- HIV, hepatitis C or Treponema pallidum antibody test positive, hepatitis B surface antigen positive;
- History of coagulation or coagulation disorder;
- History of liver or gastrointestinal diseases or other conditions that interfere with drug absorption, distribution, excretion or metabolism determined by the investigator;
- Past tumor history;
- High risk of drug allergy (such as allergic asthma patients) or history of severe allergic reactions to allergens;
- History of alcohol or drug abuse/dependence;
- Significant occupational exposure to ionizing radiation (e.g. more than 50 mSv/year) or exposure to radioactive substances or ionizing radiation for therapeutic or research purposes within the past 10 years;
- Received any drugs and treatments that may interfere with the test data or may cause serious side effects and are not completely washed out before enrollment, as judged by the investigator;
- Pregnant or lactating women;
- Hospitalization due to illness during the screening period;
- Other investigators deem it inappropriate to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-arm, Single-center, Non-randomized, Open-label Study on the Application of Amyloid Imaging Agent [18F]Florbetaben（18FBB） PET/CT Imaging to Distinguish Non-cognitively Impaired Subjects and Mild to Moderate Alzheimer Disease Subjects in Chinese Population
This is a bridging study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with Alzheimer disease.
Read the detailed description
This is a bridging study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with healthy subjects and non-cognitively impaired subjects or mild to moderate Alzheimer disease subjects. The diagnostic efficacy of the visual and quantitative assessments of 18FBB PET images for diagnosis of Alzheimer disease will be determined by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis. Imaging results were compared with reference standards to assess the ability of 18FBB PET imaging to differentiate non-cognitively impaired subjects from mild to moderate AD subjects. To investigate the pharmacokinetic characteristics of healthy subjects after single intravenous administration of 18FBB in Chinese population. Verify the safety of subjects after a single intravenous administration of 18FBB in Chinese population.
- Conditions
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies
- Being tested
- Drug: [18F]florbetaben
- Keywords
- Florbetaben, Amyloid beta-protein, Alzheimer disease
- Medical subject headings
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: [18F]florbetabenDrug
All eligible patients will receive a single administration of the imaging agent [18F]florbetaben at a radioactive dose of 300 MBq.
| Study group | Role | What they receive |
|---|---|---|
| Non-cognitively impaired subjects or mild to moderate Alzheimer disease subjects | Experimental | Visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with healthy subjects and non-cognitively impaired subjects or mild to moderate Alzheimer disease subjects. Receives: Drug: Drug: [18F]florbetaben |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verify the safety of subjects after a single intravenous administration of 18FBB in Chinese population.
Safety will be evaluated by collection of Adverse Events.
Measured: Up to 4 weeks
Evaluation of the ability of qualitative readings of PET imaging to distinguish non-cognitively impaired subjects from mild to moderate AD subjects after a single intravenous administration of 18FBB in Chinese population.
Sensitivity and specificity of18FBB PET images for diagnosis of Alzheimer disease will be measured by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis.
Measured: Up to 4 weeks
Secondary outcomes (4)
Evaluation of the ability of quantitative analysis of PET imaging to distinguish non-cognitively impaired subjects from mild to moderate AD subjects after a single intravenous administration of 18FBB in Chinese population.
Sensitivity and specificity of 18FBB PET images for diagnosis of Alzheimer disease will be measured by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis.
Measured: Up to 4 weeks
Measurement of the Maximum Plasma Concentration (Cmax) of healthy subjects after single intravenous administration of 18FBB in Chinese population.
Pharmacokinetic characteristics is described by Cmax.
Measured: Up to 4 weeks
Measurement of the Peak Plasma Time (Tmax) of healthy subjects after single intravenous administration of 18FBB in Chinese population.
Pharmacokinetic characteristics is described by Tmax.
Measured: Up to 4 weeks
Measurement of Area Under the Curve （AUC）for plasma concentration of healthy subjects after single intravenous administration of 18FBB in Chinese population.
Pharmacokinetic characteristics is described by AUC.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start28 Jan 2021
- Primary completion12 Sep 2021
- Study completion12 Sep 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible patients will receive a single administration of the imaging agent \[18F\]florbetaben at a radioactive dose of 300 MBq.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinotau Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527288
- Sponsor's protocol ID
- YZGK-XT001
- Status last verified
- Sep 2022
- First submitted
- 8 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- 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 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Single-center, Non-randomized, Open-label Study on the Application of Amyloid Imaging Agent [18F]Florbetaben（18FBB） PET/CT Imaging to Distinguish Non-cognitively Impaired Subjects and Mild to Moderate Alzheimer Disease Subjects in Chinese Population
- ClinicalTrials.gov ID
- NCT05527288
- Acronym / sponsor ID
- YZGK-XT001
- Conditions
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies
- Keywords
- Florbetaben, Amyloid beta-protein, Alzheimer disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 12 Sep 2021 (actual)
- Study completion
- 12 Sep 2021 (actual)
- First posted
- 2 Sep 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.
This is a bridging study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with Alzheimer disease.
Detailed description
This is a bridging study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with healthy subjects and non-cognitively impaired subjects or mild to moderate Alzheimer disease subjects. The diagnostic efficacy of the visual and quantitative assessments of 18FBB PET images for diagnosis of Alzheimer disease will be determined by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis. Imaging results were compared with reference standards to assess the ability of 18FBB PET imaging to differentiate non-cognitively impaired subjects from mild to moderate AD subjects. To investigate the pharmacokinetic characteristics of healthy subjects after single intravenous administration of 18FBB in Chinese population. Verify the safety of subjects after a single intravenous administration of 18FBB in Chinese population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible patients will receive a single administration of the imaging agent [18F]florbetaben at a radioactive dose of 300 MBq.
| Arm | Type | Receives |
|---|---|---|
| Non-cognitively impaired subjects or mild to moderate Alzheimer disease subjects | Experimental | Drug: Drug: [18F]florbetabenVisually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with healthy subjects and non-cognitively impaired subjects or mild to moderate Alzheimer disease subjects. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Male or female aged between 55 and 85 years old (including 55 and 85 years old);
- The education level of primary school or above, and can cooperate with the tests required for research including neuropsychological tests (cognitive ability, language ability, visual and auditory acuity can meet the requirements of the test);
- Be able to understand the purpose and experimental protocol of clinical research;
- The researcher judges that the subjects are in good health, and there is no abnormal or abnormality in the comprehensive physical examination, vital sign examination and laboratory examination, but they can participate in this bridging clinical trial according to the judgment of the clinician;
- Clinical dementia score (CDR) of 0, and the Mini-Mental State Examination Scale (MMSE score) of ≥28;
Key exclusion criteria (59 listed)
- History of various mental illnesses such as anxiety disorders, affective disorders, and schizophrenia;
- Depression Screening Scale (PHQ-9) of ≥ 5 points;
- Anxiety Disorder Screening Scale (GAD-7) of ≥ 5 points;
- Severe neurological diseases, such as cerebrovascular diseases, inflammatory or infectious diseases, or any metabolic encephalopathy, neurodegenerative diseases, including Parkinson's disease history or physical or imaging manifestations;
- History of severe craniocerebral injury, craniocerebral surgery or intracranial hematoma with permanent brain injury;
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 |
|---|---|---|
| Drug: [18F]florbetabenAll eligible patients will receive a single administration of the imaging agent [18F]florbetaben at a radioactive dose of 300 MBq. | Drug | Non-cognitively impaired subjects or mild to moderate Alzheimer disease subjects |
Primary outcome
Verify the safety of subjects after a single intravenous administration of 18FBB in Chinese population.
Time frame: Up to 4 weeks
Safety will be evaluated by collection of Adverse Events.
Evaluation of the ability of qualitative readings of PET imaging to distinguish non-cognitively impaired subjects from mild to moderate AD subjects after a single intravenous administration of 18FBB in Chinese population.
Time frame: Up to 4 weeks
Sensitivity and specificity of18FBB PET images for diagnosis of Alzheimer disease will be measured by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis.
4 secondary outcomes
Evaluation of the ability of quantitative analysis of PET imaging to distinguish non-cognitively impaired subjects from mild to moderate AD subjects after a single intravenous administration of 18FBB in Chinese population.
Time frame: Up to 4 weeks
Measurement of the Maximum Plasma Concentration (Cmax) of healthy subjects after single intravenous administration of 18FBB in Chinese population.
Time frame: Up to 4 weeks
Measurement of the Peak Plasma Time (Tmax) of healthy subjects after single intravenous administration of 18FBB in Chinese population.
Time frame: Up to 4 weeks
Measurement of Area Under the Curve （AUC）for plasma concentration of healthy subjects after single intravenous administration of 18FBB in Chinese population.
Time frame: Up to 4 weeks
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 2 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug: [18F]florbetaben in people with Alzheimer Disease and Dementia, run by Sinotau Pharmaceutical Group at 1 site in China.
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 25 inclusion and 59 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 2 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 China. 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?
Verify the safety of subjects after a single intravenous administration of 18FBB in Chinese population. (time frame: Up to 4 weeks). 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 2 Sep 2022.