Alzheimer DiseaseEarly Phase 1NCT02638519
HP Xenon-129 fMRI of Healthy Volunteers and Participants With Alzheimer's Disease
A Early Phase 1 study testing Traditional Proton fMRI, Hyperpolarized Xenon-129 fMRI and Hyperpolarized Xenon-129 in people with Alzheimer Disease, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.
Trial summary
This study involves imaging participants' brains using MRI. The goal is to develop a high-resolution, high-sensitivity imaging tool, hyperpolarized xenon functional brain magnetic resonance imaging, which can provide more sensitive measurement of brain function, facilitating the development of drugs for more… 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
- What is being tested?
- Traditional Proton fMRI, Hyperpolarized Xenon-129 fMRI and Hyperpolarized Xenon-129
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jun 2016to 19 Apr 2022
- Phase
- Early Phase 1
- 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
- A participant is eligible for inclusion in the study if the individual meets all of the following criteria:
- Self-reported proficiency in English language.
- Equal to or more than 8 years of education.
- Normal or corrected to normal vision.
- Able to provide informed consent.
- Able to hold their breath for 20 seconds.
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- Normal cognition for healthy participant group inclusion criteria:
- Preserved independence in functional abilities.
- MoCA score no less than 26.
- Males and non-lactating females of 18 to 85 years of age.
- Alzheimer's disease group inclusion criteria:
- Participants meet National Institute on Aging-Alzheimer's Association for probable or possible Alzheimer's Disease dementia.
- MoCA score no less than 16.
- Males and non-lactating females of 60 to 85 years of age.
- Have a family member, close friend, or LAR that can be present for the informed consent process and study visits.
Who cannot join
- A participant is ineligible for the study if the individual meets any of the following criteria:
- Serious underlying medical condition, other, then the condition being investigated, which may affect cognitive function of the participant (in the opinion of the investigator): substance abuse, psychotic or depressive disorder, advanced or poorly controlled cardiac, pulmonary, hepatic, renal, neurological disorders in which the patient has significant speech, visual, motor or cognitive deficit, seizure disorders, endocrine or infectious disease or active malignancy.
- MRI incompatibility as determined by MR Technologist during MRI screening.
- Self-identifies as claustrophobic.
- Female exclusion only: Are or may be pregnant; Planning on becoming pregnant.
- Is a student currently enrolled in a course at Lakehead University where the Principal Investigator (PI) is the instructor.
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- Is a student currently enrolled in a degree program at Lakehead University where the PI is their direct thesis supervisor.
- Is currently an employee of the PI at the Thunder Bay Regional Research Institute (TBRRI) and/or Lakehead University.
- Normal cognition group exclusion criteria:
- 1. History of diagnosed neurological disease or injury.
- Alzheimer's disease group exclusion criteria:
- Existing diagnosis of dementia of etiology other than Alzheimer's disease.
- Acute Delirium on the day of scanning (CAM tool assessment)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
About this study
Official title: Hyperpolarized Xenon-129 Functional Magnetic Resonance Imaging of Healthy Volunteers and Participants With Alzheimer's Disease
This study involves imaging participants' brains using MRI. The goal is to develop a high-resolution, high-sensitivity imaging tool, hyperpolarized xenon functional brain magnetic resonance imaging, which can provide more sensitive measurement of brain function, facilitating the development of drugs for more successful treatment of Alzheimer's disease.
Read the detailed description
The described study is a pilot study in which the investigators aim to develop an enhanced sensitivity tool for assessment of neural function. Participation involves at least two study visits no longer than three hours in length each. During visit 1, informed consent and screening for eligibility will take place. During visit 2, fMRI scanning will take place in which participants will complete simple tasks. Two types of MRI scans will be performed: traditional proton fMRI and hyperpolarized xenon-129 fMRI (HP 129Xe fMRI) scans. The trade name for xenon-129 hyperpolarized with a Xemed LLC polarizer is NeuroXene.
Participants will be placed in the 3T MRI at the Thunder Bay Regional Research Institute with a Clinical MR Solutions (CMRS) Dual Brain Coil that fits over their head like a helmet. Several inhalation procedures will be performed by participants when breathing NeuroXene from a tube in the scanner. Preparation and administration of NeuroXene and the CMRS Dual Brain Coil will be carried out according to the SOP's developed by the TBRRI and Xemed LLC.
MRI scanning will be performed with a MR Tech and Registered Respiratory Therapist present. Dispensing of 129Xe will be monitored using a gas dispensing form and a drug accountability log. This study will have a monitor assigned to it from the TBRRI that is not involved in this clinical trial. This is to ensure participant safety and adherence to the protocol.
- Conditions
- Alzheimer Disease
- Being tested
- Traditional Proton fMRI, Hyperpolarized Xenon-129 fMRI, Hyperpolarized Xenon-129, 1H-129Xe Dual-Tuned Quadrature Head Coil
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Proton fMRIOther
Conventional proton fMRI will be performed. During the functional imaging acquisitions, the participant will be asked by the research team to perform simple tasks. These tasks will be completed while the participant breathes air (normal breathing).
Hyperpolarized Xenon-129 fMRIOther
Also called HP 129Xe fMRI
HP 129Xe fMRI data will be acquired from all participants. Hyperpolarized xenon (NeuroXene) is expected to produce images that provide more clinically relevant information than traditional proton scans. Simple tasks will be performed by participants while breathing NeuroXene according to several inhalation procedures.
Hyperpolarized Xenon-129Drug
Also called NeuroXene
Participants will be asked to inhale specified amounts of NeuroXene according to several inhalation procedures. NeuroXene is the trade name for hyperpolarization of xenon-129 balanced with oxygen and nitrogen using a Xemed LLC polarizer. Hyperpolarization does not change the chemical or physical properties of xenon gas.
1H-129Xe Dual-Tuned Quadrature Head CoilDevice
A 1H-129Xe dual-tuned quadrature head coil (Clinical MR Solutions, LLC) will be used in this study. The RF coil will be used to acquire MRI images of the human brain after inhalation of hyperpolarized xenon-129 gas, and permits the acquisition of both conventional proton and HP xenon gas images.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Other | Healthy volunteers will inhale NeuroXene using various breathing methods. The CMRS 1H-129Xe dual-tuned quadrature head coil will be used to acquire MRI images of the human brain after inhalation of NeuroXene. The coil permits the acquisition of both conventional proton and HP xenon gas images. Two types of MRI scans will be performed: Traditional proton fMRI and Hyperpolarized Xenon-129 fMRI. The order of scans will be randomized to account for bias caused by scan order. Receives: Other: Traditional Proton fMRI; Other: Hyperpolarized Xenon-129 fMRI; Drug: Hyperpolarized Xenon-129; Device: 1H-129Xe Dual-Tuned Quadrature Head Coil |
| Alzheimer's Disease Participants | Other | Alzheimer's disease participants will inhale NeuroXene using various breathing methods. The CMRS 1H-129Xe dual-tuned quadrature head coil will be used to acquire MRI images of the human brain after inhalation of NeuroXene. The coil permits the acquisition of both conventional proton and HP xenon gas images. Two types of MRI scans will be performed: Traditional proton fMRI and Hyperpolarized Xenon-129 fMRI. The order of scans will be randomized to account for bias caused by scan order. Receives: Other: Traditional Proton fMRI; Other: Hyperpolarized Xenon-129 fMRI; Drug: Hyperpolarized Xenon-129; Device: 1H-129Xe Dual-Tuned Quadrature Head Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal-to-Noise Ratio (SNR)
All scans will be optimized for the highest SNR possible; No aggregation of data
Measured: Three years
Secondary outcomes (1)
P-Value
To be calculated from a students paired t-test for signal change between healthy participant scans and participants with Alzheimer disease
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study start27 Jun 2016
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Why it stopped: Unable to reach the target enrollment of 40 participants with Alzheimer's disease.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thunder Bay Regional Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Lakehead University, Thunder Bay Regional Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Mitchell Albert, Ph.D., Principal investigator, Thunder Bay Regional Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638519
- Sponsor's protocol ID
- RP-307-08312015
- Status last verified
- Aug 2024
- First submitted
- 3 Dec 2015
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Agosta F, Pievani M, Geroldi C, Copetti M, Frisoni GB, Filippi M. Resting state fMRI in Alzheimer's disease: beyond the default mode network. Neurobiol Aging. 2012 Aug;33(8):1564-78. doi: 10.1016/j.neurobiolaging.2011.06.007. Epub 2011 Aug 3.
PubMed 21813210Albert MS, Cates GD, Driehuys B, Happer W, Saam B, Springer CS Jr, Wishnia A. Biological magnetic resonance imaging using laser-polarized 129Xe. Nature. 1994 Jul 21;370(6486):199-201. doi: 10.1038/370199a0.
PubMed 8028666Hane FT, Li T, Plata JA, Hassan A, Granberg K, Albert MS. Inhaled Xenon Washout as a Biomarker of Alzheimer's Disease. Diagnostics (Basel). 2018 Jun 6;8(2):41. doi: 10.3390/diagnostics8020041.
PubMed 29882765Grynko V, Shepelytskyi Y, Li T, Hassan A, Granberg K, Albert MS. Hyperpolarized 129 Xe multi-slice imaging of the human brain using a 3D gradient echo pulse sequence. Magn Reson Med. 2021 Dec;86(6):3175-3181. doi: 10.1002/mrm.28932. Epub 2021 Jul 17.
PubMed 34272774Shepelytskyi Y, Grynko V, Rao MR, Li T, Agostino M, Wild JM, Albert MS. Hyperpolarized 129 Xe imaging of the brain: Achievements and future challenges. Magn Reson Med. 2022 Jul;88(1):83-105. doi: 10.1002/mrm.29200. Epub 2022 Mar 7.
PubMed 35253919Shepelytskyi Y, Grynko V, Li T, Hassan A, Granberg K, Albert MS. The effects of an initial depolarization pulse on dissolved phase hyperpolarized 129 Xe brain MRI. Magn Reson Med. 2021 Dec;86(6):3147-3155. doi: 10.1002/mrm.28918. Epub 2021 Jul 13.
PubMed 34254356Shepelytskyi Y, Hane FT, Grynko V, Li T, Hassan A, Albert MS. Hyperpolarized 129Xe Time-of-Flight MR Imaging of Perfusion and Brain Function. Diagnostics (Basel). 2020 Aug 25;10(9):630. doi: 10.3390/diagnostics10090630.
PubMed 32854196
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized Xenon-129 Functional Magnetic Resonance Imaging of Healthy Volunteers and Participants With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02638519
- Acronym / sponsor ID
- RP-307-08312015
- Conditions
- Alzheimer Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to reach the target enrollment of 40 participants with Alzheimer's disease.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Thunder Bay Regional Health Research InstituteUniversity, hospital or other
- Collaborators
- Lakehead University, Thunder Bay Regional Health Sciences Centre
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 23 Dec 2015 (estimated)
- 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 study involves imaging participants' brains using MRI. The goal is to develop a high-resolution, high-sensitivity imaging tool, hyperpolarized xenon functional brain magnetic resonance imaging, which can provide more sensitive measurement of brain function, facilitating the development of drugs for more successful treatment of Alzheimer's disease.
Detailed description
The described study is a pilot study in which the investigators aim to develop an enhanced sensitivity tool for assessment of neural function. Participation involves at least two study visits no longer than three hours in length each. During visit 1, informed consent and screening for eligibility will take place. During visit 2, fMRI scanning will take place in which participants will complete simple tasks. Two types of MRI scans will be performed: traditional proton fMRI and hyperpolarized xenon-129 fMRI (HP 129Xe fMRI) scans. The trade name for xenon-129 hyperpolarized with a Xemed LLC polarizer is NeuroXene.
Participants will be placed in the 3T MRI at the Thunder Bay Regional Research Institute with a Clinical MR Solutions (CMRS) Dual Brain Coil that fits over their head like a helmet. Several inhalation procedures will be performed by participants when breathing NeuroXene from a tube in the scanner. Preparation and administration of NeuroXene and the CMRS Dual Brain Coil will be carried out according to the SOP's developed by the TBRRI and Xemed LLC.
MRI scanning will be performed with a MR Tech and Registered Respiratory Therapist present. Dispensing of 129Xe will be monitored using a gas dispensing form and a drug accountability log. This study will have a monitor assigned to it from the TBRRI that is not involved in this clinical trial. This is to ensure participant safety and adherence to the protocol.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | Other: Traditional Proton fMRI, Other: Hyperpolarized Xenon-129 fMRI, Drug: Hyperpolarized Xenon-129, Device: 1H-129Xe Dual-Tuned Quadrature Head CoilHealthy volunteers will inhale NeuroXene using various breathing methods. The CMRS 1H-129Xe dual-tuned quadrature head coil will be used to acquire MRI images of the human brain after inhalation of NeuroXene. The coil permits the acquisition of both conventional proton and HP xenon gas images. Two types of MRI scans will be performed: Traditional proton fMRI and Hyperpolarized Xenon-129 fMRI. The order of scans will be randomized to account for bias caused by scan order. |
| Alzheimer's Disease Participants | Other | Other: Traditional Proton fMRI, Other: Hyperpolarized Xenon-129 fMRI, Drug: Hyperpolarized Xenon-129, Device: 1H-129Xe Dual-Tuned Quadrature Head CoilAlzheimer's disease participants will inhale NeuroXene using various breathing methods. The CMRS 1H-129Xe dual-tuned quadrature head coil will be used to acquire MRI images of the human brain after inhalation of NeuroXene. The coil permits the acquisition of both conventional proton and HP xenon gas images. Two types of MRI scans will be performed: Traditional proton fMRI and Hyperpolarized Xenon-129 fMRI. The order of scans will be randomized to account for bias caused by scan order. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- A participant is eligible for inclusion in the study if the individual meets all of the following criteria:
- Self-reported proficiency in English language.
- Equal to or more than 8 years of education.
- Normal or corrected to normal vision.
- Able to provide informed consent.
Key exclusion criteria (13 listed)
- A participant is ineligible for the study if the individual meets any of the following criteria:
- Serious underlying medical condition, other, then the condition being investigated, which may affect cognitive function of the participant (in the opinion of the investigator): substance abuse, psychotic or depressive disorder, advanced or poorly controlled cardiac, pulmonary, hepatic, renal, neurological disorders in which the patient has significant speech, visual, motor or cognitive deficit, seizure disorders, endocrine or infectious disease or active malignancy.
- MRI incompatibility as determined by MR Technologist during MRI screening.
- Self-identifies as claustrophobic.
- Female exclusion only: Are or may be pregnant; Planning on becoming pregnant.
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 |
|---|---|---|
| Traditional Proton fMRIConventional proton fMRI will be performed. During the functional imaging acquisitions, the participant will be asked by the research team to perform simple tasks. These tasks will be completed while the participant breathes air (normal breathing). | Other | Alzheimer's Disease Participants, Healthy Volunteers |
| Hyperpolarized Xenon-129 fMRIAlso: HP 129Xe fMRIHP 129Xe fMRI data will be acquired from all participants. Hyperpolarized xenon (NeuroXene) is expected to produce images that provide more clinically relevant information than traditional proton scans. Simple tasks will be performed by participants while breathing NeuroXene according to several inhalation procedures. | Other | Alzheimer's Disease Participants, Healthy Volunteers |
| Hyperpolarized Xenon-129Also: NeuroXeneParticipants will be asked to inhale specified amounts of NeuroXene according to several inhalation procedures. NeuroXene is the trade name for hyperpolarization of xenon-129 balanced with oxygen and nitrogen using a Xemed LLC polarizer. Hyperpolarization does not change the chemical or physical properties of xenon gas. | Drug | Alzheimer's Disease Participants, Healthy Volunteers |
| 1H-129Xe Dual-Tuned Quadrature Head CoilA 1H-129Xe dual-tuned quadrature head coil (Clinical MR Solutions, LLC) will be used in this study. The RF coil will be used to acquire MRI images of the human brain after inhalation of hyperpolarized xenon-129 gas, and permits the acquisition of both conventional proton and HP xenon gas images. | Device | Alzheimer's Disease Participants, Healthy Volunteers |
Primary outcome
Signal-to-Noise Ratio (SNR)
Time frame: Three years
All scans will be optimized for the highest SNR possible; No aggregation of data
1 secondary outcome
P-Value
Time frame: Three years
Results and safety
The study was stopped early (reason given: Unable to reach the target enrollment of 40 participants with Alzheimer's disease.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 21813210Agosta F, Pievani M, Geroldi C, Copetti M, Frisoni GB, Filippi M. Resting state fMRI in Alzheimer's disease: beyond the default mode network. Neurobiol Aging. 2012 Aug;33(8):1564-78. doi: 10.1016/j.neurobiolaging.2011.06.007. Epub 2011 Aug 3.
- Background: PubMed 8028666Albert MS, Cates GD, Driehuys B, Happer W, Saam B, Springer CS Jr, Wishnia A. Biological magnetic resonance imaging using laser-polarized 129Xe. Nature. 1994 Jul 21;370(6486):199-201. doi: 10.1038/370199a0.
- Results publication: PubMed 29882765Hane FT, Li T, Plata JA, Hassan A, Granberg K, Albert MS. Inhaled Xenon Washout as a Biomarker of Alzheimer's Disease. Diagnostics (Basel). 2018 Jun 6;8(2):41. doi: 10.3390/diagnostics8020041.
- Results publication: PubMed 34272774Grynko V, Shepelytskyi Y, Li T, Hassan A, Granberg K, Albert MS. Hyperpolarized 129 Xe multi-slice imaging of the human brain using a 3D gradient echo pulse sequence. Magn Reson Med. 2021 Dec;86(6):3175-3181. doi: 10.1002/mrm.28932. Epub 2021 Jul 17.
- Results publication: PubMed 35253919Shepelytskyi Y, Grynko V, Rao MR, Li T, Agostino M, Wild JM, Albert MS. Hyperpolarized 129 Xe imaging of the brain: Achievements and future challenges. Magn Reson Med. 2022 Jul;88(1):83-105. doi: 10.1002/mrm.29200. Epub 2022 Mar 7.
- Results publication: PubMed 34254356Shepelytskyi Y, Grynko V, Li T, Hassan A, Granberg K, Albert MS. The effects of an initial depolarization pulse on dissolved phase hyperpolarized 129 Xe brain MRI. Magn Reson Med. 2021 Dec;86(6):3147-3155. doi: 10.1002/mrm.28918. Epub 2021 Jul 13.
- Results publication: PubMed 32854196Shepelytskyi Y, Hane FT, Grynko V, Li T, Hassan A, Albert MS. Hyperpolarized 129Xe Time-of-Flight MR Imaging of Perfusion and Brain Function. Diagnostics (Basel). 2020 Aug 25;10(9):630. doi: 10.3390/diagnostics10090630.
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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.
Mitchell Albert, Ph.D. principal investigator
Thunder Bay Regional Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Traditional Proton fMRI, Hyperpolarized Xenon-129 fMRI and Hyperpolarized Xenon-129 in people with Alzheimer Disease, run by Thunder Bay Regional Health Research Institute 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 15 inclusion and 13 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: stopped early, as of the sponsor's last update on 15 Oct 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to reach the target enrollment of 40 participants with Alzheimer's disease.). Results are not available in the source record.
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?
Signal-to-Noise Ratio (SNR) (time frame: Three years). 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 NCT02638519, which also lists 7 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 15 Oct 2024.