Chronic Traumatic EncephalopathyDIAGNOSE-CTENCT02798185
The DIAGNOSE-CTE Research Project
An observational study of Chronic Traumatic Encephalopathy, run by Boston University at 1 site in United States.
Trial summary
This is a study to develop methods of diagnosing chronic traumatic encephalopathy (CTE) during life, as well as to examine possible risk factors for this neurodegenerative disease. One component of this study is the use of an investigational PET scan radio tracer to detect abnormal tau protein in the brain. Read more about this study
- Who is it for?
- Ages 45 to 74 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Traumatic Encephalopathy
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 15 Nov 2023
- 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 45 to 74 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Former National Football League Players, Former Varsity Level College Football Players, Healthy Controls
Who may be able to join
- Former NFL Players:
- English as primary language
- No MRI or Lumbar Puncture (LP) contraindications
- Have played ≥12 years of organized football (including =>3 in college and =>3 seasons in the NFL)
- Must have played one of following positions offensive lineman, defensive lineman, linebacker, tight end, wide receiver, running back, or defensive back.
- Agree to provide name and contact information of a study partner who will complete questionnaires regarding subject's mood, behavior, thinking and cognitive function should the subject enroll in the study.
Show all 51Show fewer
- Former Collegiate Football Players
- English as primary language
- No MRI or Lumbar Puncture (LP) contraindications
- Must have played =>6 years of organized football (with => 3 years at the college level, but no organized football or other contact sport following college.)
- Must have played one of following positions offensive lineman, defensive lineman, linebacker, tight end, wide receiver, running back, or defensive back.
- No military service
- Agree to provide name and contact information of a study partner who will complete questionnaires regarding subject's mood, behavior, thinking and cognitive function should the subject enroll in the study.
- Control Group
- English as primary language
- No MRI or Lumbar Puncture (LP) contraindications
- No history of organized contact sports or known traumatic brain injury (TBI) and/or moderate/severe concussions
- No history of participation in any of the following organized sports at any level: football, hockey, rugby, soccer, lacrosse, wrestling, boxing, gymnastics, martial arts, and kickboxing.
- No military service.
- Must have BMI >=24
- Must have at least 2 years post-secondary education at a 4-year accredited college or university, or have an associate's degree if they did not attend a 4-year accredited college or university
- Must have never been diagnosed with, or treated for, any of the following: depression, manic-depressive or bipolar disorder, anxiety, or other psychiatric or mental health problems
- Agree to provide name and contact information of a study partner who will complete questionnaires regarding subject's mood, behavior, thinking and cognitive function should the subject enroll in the study.
- Must be asymptomatic when screened by telephone.
- Former NFL and Varsity Collegiate Football Players Exclusion Criteria:
- If they do not meet inclusion criteria
- If they have a history of clinical stroke confirmed on neuroimaging
- If they have vision or hearing impairment significant enough to compromise neuropsychological testing
- If they have been hospitalized or treated in an emergency room following a severe injury to their head since they stopped playing football
- If they are unable to undergo MRI/PET Scan
- If they have a spinal fusion at L3-4 and/or L4-5
- If they are unable to travel to one of 4 study sites to participate
- If they are an insulin dependent diabetic
- If they cannot provide the name and contact information of an eligible study partner
- If they are taking blood thinners that would make LP unsafe
- If they have a type of abnormal heart rhythm called Torsades de pointes AKA TdP
- If they have an abnormal heart rhythm disorder called QT Prolongation or take certain medications known to cause QT Prolongation
- If they do not agree to all study tests and procedures
- If they are unable to consent to study procedures
- Control Group Exclusion:
- If they do not meet inclusion criteria
- If they have vision or hearing impairment significant enough to compromise neuropsychological testing
- If they are unable to undergo MRI/PET Scan
- If they have a spinal fusion at L3-4 and/or L4-5
- If they are an insulin dependent diabetic
- If they are unable to travel to one of 4 study sites to participate
- If they cannot provide the name and contact information of an eligible study partner
- If they report any cognitive concerns or dementia during screening process
- If they have a type of abnormal heart rhythm called Torsades de pointes AKA TdP
- If they have an abnormal heart rhythm disorder called QT Prolongation or take certain medications known to cause QT Prolongation
- If they are unable to consent to study procedures
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Medicine
Boston, Massachusetts, 02118
About this study
Official title: Diagnostics, Imaging And Genetics Network for the Objective Study and Evaluation of Chronic Traumatic Encephalopathy (DIAGNOSE CTE) Research Project
This is a study to develop methods of diagnosing chronic traumatic encephalopathy (CTE) during life, as well as to examine possible risk factors for this neurodegenerative disease. One component of this study is the use of an investigational PET scan radio tracer to detect abnormal tau protein in the brain.
Read the detailed description
Chronic Traumatic Encephalopathy (CTE) is a neurodegenerative disease characterized by a distinct deposition of phosphorylated tau (p-tau) in neurons and astrocytes in a pattern that is unique from other tauopathies, including Alzheimer's disease (AD). Although the neuropathological features of CTE have become further clarified in recent years, the clinical presentation of CTE is still not well characterized. Diagnostic criteria have only recently been published and lack validation.
Neuroimaging and fluid biomarkers developed for the diagnosis of other neurodegenerative diseases have only been used in preliminary studies of individuals at high risk for CTE, namely athletes with histories of significant exposure to repetitive head impacts (RHI), such as former football players and boxers. There is thus an urgent need to develop accurate methods for detecting and diagnosing CTE during life so that effective interventions for prevention and treatment can be developed. Moreover, though a history of RHI is a necessary risk factor for CTE, it alone is not sufficient. There is a need to understand what specific aspects of RHI exposure places an individual at increased risk for CTE and to examine potential genetic polymorphisms that modify that risk.
To address these needs, the investigators are conducting a multidisciplinary, multicenter, longitudinal study of former NFL and varsity college football players (with and without symptoms), and a control group of asymptomatic same-age men without any history of RHI exposure, traumatic brain injury or military service. Subjects will be seen at 1 of 4 participating study sites in Boston; Las Vegas, ; New York; and Scottsdale/Phoenix . Subjects will undergo a baseline evaluation and a 3 year follow-up evaluation (currently former college players will not complete the follow-up evaluation). Each evaluation will be take place over a 3 day period and consist of the following procedures/tests: neurocognitive testing, determination of functional independence, neuropsychiatric examination (with measures of mood and behavior), neurological assessment (motor, headache, postural stability), neuroimaging (including structural, diffusion, functional, biochemical, and molecular imaging), lumbar punctures (for Cerebrospinal Fluid (CSF) biomarkers), blood draws (for blood biomarkers and DNA), and saliva samples (for biomarkers).
- Conditions
- Chronic Traumatic Encephalopathy
- Medical subject headings
- Chronic Traumatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Former NFL Players | 120 former National Football League players with and without reported cognitive, mood and behavior symptoms will be enrolled in this study. | |
| Former College Football Players | 60 former college football players with and without reported cognitive, mood and behavior symptoms will be enrolled in this study. | |
| Control Group | 60 asymptomatic same-age men without any history of participation in contact sports, military service, or traumatic brain injury will be enrolled in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroimaging Positron Emission Tomography for Amyloid Biomarker
Subjects will undergo a Florbetapir Positron Emission Tomography (PET) scan.
The Outcome Measurement for the Florbetapir PET Scan will be "elevated" or "not elevated"
Measured: One-Time
Fluid Biomarkers
The following Biospecimens will be collected from subjects:
Saliva, blood and cerebral spinal fluid (CSF). CSF will be collected by a lumbar puncture (spinal tap) Fluid biomarkers will be analyzed for the in vivo detection of CTE.
Measured: 3 Years
Neuropsychiatric and Neurocognitive Tests
Composite scores (presented as z scores) based on factor analytic methodology in the following domains:
- Mood
- Behavior Regulation
- Attention, Information Processing and Psychomotor Speed
- Executive Functioning
- Verbal Memory
- Visual Memory
- Visual-Spatial Ability
- Language
Measured: 3 years
Neurological Evaluation
Subjects will undergo The Movement Disorder Society's Unified Parkinson's Disorders Rating Scale (MDS-UPDRS) Neurological Evaluation by a physician. This evaluation will be analyzed to characterize the clinical presentation of CTE.
Measured: 3 years
Magnetic Resonance Imagining Biomarkers
Subjects will undergo Diffuser Tension Imaging (dti) and Functional MRI scans, to assess structural brain volumetrics, fractional anisotropy, radial diffusivity, and changes in brain activity associated with blood flow.
Measured: 3 years
Neuroimaging Positron Emission Tomography for Tau Biomarker
Subjects will undergo an Investigational drug: AV1451 Positron Emission Tomography (PET) scan.
The Outcome Measurement for AV1451 PET scan will be Standardized Uptake Value Ratio (SUVR) of Tau.
Measured: 3 years
Magnetic Resonance Spectroscopy Biomarkers
Subject will also undergo Magnetic Resonance Spectroscopy (MRS) to measure glutamate, glutamine and myoinosotol.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion31 Oct 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Traumatic EncephalopathyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Banner Health, Brigham and Women's Hospital, NYU Langone Health, The Cleveland Clinic, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Robert A Stern, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798185
- Sponsor's protocol ID
- H-34799
- Other IDs
- U01NS093334
- Acronym
- DIAGNOSE-CTE
- Status last verified
- Dec 2023
- First submitted
- 20 May 2016
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with FITBIR and other data sharing portals
Publications
Su Y, Protas H, Luo J, Chen K, Alosco ML, Adler CH, Balcer LJ, Bernick C, Au R, Banks SJ, Barr WB, Coleman MJ, Dodick DW, Katz DI, Marek KL, McClean MD, McKee AC, Mez J, Daneshvar DH, Palmisano JN, Peskind ER, Turner RW 2nd, Wethe JV, Rabinovici G, Johnson K, Tripodis Y, Cummings JL, Shenton ME, Stern RA, Reiman EM; DIAGNOSE CTE Research Project Investigators. Flortaucipir tau PET findings from former professional and college American football players in the DIAGNOSE CTE research project. Alzheimers Dement. 2024 Mar;20(3):1827-1838. doi: 10.1002/alz.13602. Epub 2023 Dec 22.
PubMed 38134231Stern RA, Trujillo-Rodriguez D, Tripodis Y, Pulukuri SV, Alosco ML, Adler CH, Balcer LJ, Bernick C, Baucom Z, Marek KL, McClean MD, Johnson KA, McKee AC, Stein TD, Mez J, Palmisano JN, Cummings JL, Shenton ME, Reiman EM; DIAGNOSE CTE Research Project Investigators. Amyloid PET across the cognitive spectrum in former professional and college American football players: findings from the DIAGNOSE CTE Research Project. Alzheimers Res Ther. 2023 Oct 5;15(1):166. doi: 10.1186/s13195-023-01315-5.
PubMed 37798671Alosco ML, Mariani ML, Adler CH, Balcer LJ, Bernick C, Au R, Banks SJ, Barr WB, Bouix S, Cantu RC, Coleman MJ, Dodick DW, Farrer LA, Geda YE, Katz DI, Koerte IK, Kowall NW, Lin AP, Marcus DS, Marek KL, McClean MD, McKee AC, Mez J, Palmisano JN, Peskind ER, Tripodis Y, Turner RW 2nd, Wethe JV, Cummings JL, Reiman EM, Shenton ME, Stern RA; DIAGNOSE CTE Research Project Investigators. Developing methods to detect and diagnose chronic traumatic encephalopathy during life: rationale, design, and methodology for the DIAGNOSE CTE Research Project. Alzheimers Res Ther. 2021 Aug 12;13(1):136. doi: 10.1186/s13195-021-00872-x.
PubMed 34384490
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostics, Imaging And Genetics Network for the Objective Study and Evaluation of Chronic Traumatic Encephalopathy (DIAGNOSE CTE) Research Project
- ClinicalTrials.gov ID
- NCT02798185
- Acronym / sponsor ID
- DIAGNOSE-CTE / H-34799
- Conditions
- Chronic Traumatic Encephalopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic, Banner Health, Brigham and Women's Hospital, NYU Langone Health, The Cleveland Clinic, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Aug 2016 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 14 Jun 2016 (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 is a study to develop methods of diagnosing chronic traumatic encephalopathy (CTE) during life, as well as to examine possible risk factors for this neurodegenerative disease. One component of this study is the use of an investigational PET scan radio tracer to detect abnormal tau protein in the brain.
Detailed description
Chronic Traumatic Encephalopathy (CTE) is a neurodegenerative disease characterized by a distinct deposition of phosphorylated tau (p-tau) in neurons and astrocytes in a pattern that is unique from other tauopathies, including Alzheimer's disease (AD). Although the neuropathological features of CTE have become further clarified in recent years, the clinical presentation of CTE is still not well characterized. Diagnostic criteria have only recently been published and lack validation.
Neuroimaging and fluid biomarkers developed for the diagnosis of other neurodegenerative diseases have only been used in preliminary studies of individuals at high risk for CTE, namely athletes with histories of significant exposure to repetitive head impacts (RHI), such as former football players and boxers. There is thus an urgent need to develop accurate methods for detecting and diagnosing CTE during life so that effective interventions for prevention and treatment can be developed. Moreover, though a history of RHI is a necessary risk factor for CTE, it alone is not sufficient. There is a need to understand what specific aspects of RHI exposure places an individual at increased risk for CTE and to examine potential genetic polymorphisms that modify that risk.
To address these needs, the investigators are conducting a multidisciplinary, multicenter, longitudinal study of former NFL and varsity college football players (with and without symptoms), and a control group of asymptomatic same-age men without any history of RHI exposure, traumatic brain injury or military service. Subjects will be seen at 1 of 4 participating study sites in Boston; Las Vegas, ; New York; and Scottsdale/Phoenix . Subjects will undergo a baseline evaluation and a 3 year follow-up evaluation (currently former college players will not complete the follow-up evaluation). Each evaluation will be take place over a 3 day period and consist of the following procedures/tests: neurocognitive testing, determination of functional independence, neuropsychiatric examination (with measures of mood and behavior), neurological assessment (motor, headache, postural stability), neuroimaging (including structural, diffusion, functional, biochemical, and molecular imaging), lumbar punctures (for Cerebrospinal Fluid (CSF) biomarkers), blood draws (for blood biomarkers and DNA), and saliva samples (for biomarkers).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Former NFL Players | – | –120 former National Football League players with and without reported cognitive, mood and behavior symptoms will be enrolled in this study. |
| Former College Football Players | – | –60 former college football players with and without reported cognitive, mood and behavior symptoms will be enrolled in this study. |
| Control Group | – | –60 asymptomatic same-age men without any history of participation in contact sports, military service, or traumatic brain injury will be enrolled in this study. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Former National Football League Players, Former Varsity Level College Football Players, Healthy Controls
Key inclusion criteria (51 listed)
- English as primary language
- No MRI or Lumbar Puncture (LP) contraindications
- Have played ≥12 years of organized football (including =>3 in college and =>3 seasons in the NFL)
- Must have played one of following positions offensive lineman, defensive lineman, linebacker, tight end, wide receiver, running back, or defensive back.
- Agree to provide name and contact information of a study partner who will complete questionnaires regarding subject's mood, behavior, thinking and cognitive function should the subject enroll in the study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuroimaging Positron Emission Tomography for Amyloid Biomarker
Time frame: One-Time
Subjects will undergo a Florbetapir Positron Emission Tomography (PET) scan. The Outcome Measurement for the Florbetapir PET Scan will be "elevated" or "not elevated"
Fluid Biomarkers
Time frame: 3 Years
The following Biospecimens will be collected from subjects: Saliva, blood and cerebral spinal fluid (CSF). CSF will be collected by a lumbar puncture (spinal tap) Fluid biomarkers will be analyzed for the in vivo detection of CTE.
Neuropsychiatric and Neurocognitive Tests
Time frame: 3 years
Composite scores (presented as z scores) based on factor analytic methodology in the following domains: * Mood * Behavior Regulation * Attention, Information Processing and Psychomotor Speed * Executive Functioning * Verbal Memory * Visual Memory * Visual-Spatial Ability * Language
Neurological Evaluation
Time frame: 3 years
Subjects will undergo The Movement Disorder Society's Unified Parkinson's Disorders Rating Scale (MDS-UPDRS) Neurological Evaluation by a physician. This evaluation will be analyzed to characterize the clinical presentation of CTE.
Magnetic Resonance Imagining Biomarkers
Time frame: 3 years
Subjects will undergo Diffuser Tension Imaging (dti) and Functional MRI scans, to assess structural brain volumetrics, fractional anisotropy, radial diffusivity, and changes in brain activity associated with blood flow.
Neuroimaging Positron Emission Tomography for Tau Biomarker
Time frame: 3 years
Subjects will undergo an Investigational drug: AV1451 Positron Emission Tomography (PET) scan. The Outcome Measurement for AV1451 PET scan will be Standardized Uptake Value Ratio (SUVR) of Tau.
Magnetic Resonance Spectroscopy Biomarkers
Time frame: 3 years
Subject will also undergo Magnetic Resonance Spectroscopy (MRS) to measure glutamate, glutamine and myoinosotol.
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 5 Dec 2023.
- Derived from this study: PubMed 38134231Su Y, Protas H, Luo J, Chen K, Alosco ML, Adler CH, Balcer LJ, Bernick C, Au R, Banks SJ, Barr WB, Coleman MJ, Dodick DW, Katz DI, Marek KL, McClean MD, McKee AC, Mez J, Daneshvar DH, Palmisano JN, Peskind ER, Turner RW 2nd, Wethe JV, Rabinovici G, Johnson K, Tripodis Y, Cummings JL, Shenton ME, Stern RA, Reiman EM; DIAGNOSE CTE Research Project Investigators. Flortaucipir tau PET findings from former professional and college American football players in the DIAGNOSE CTE research project. Alzheimers Dement. 2024 Mar;20(3):1827-1838. doi: 10.1002/alz.13602. Epub 2023 Dec 22.
- Derived from this study: PubMed 37798671Stern RA, Trujillo-Rodriguez D, Tripodis Y, Pulukuri SV, Alosco ML, Adler CH, Balcer LJ, Bernick C, Baucom Z, Marek KL, McClean MD, Johnson KA, McKee AC, Stein TD, Mez J, Palmisano JN, Cummings JL, Shenton ME, Reiman EM; DIAGNOSE CTE Research Project Investigators. Amyloid PET across the cognitive spectrum in former professional and college American football players: findings from the DIAGNOSE CTE Research Project. Alzheimers Res Ther. 2023 Oct 5;15(1):166. doi: 10.1186/s13195-023-01315-5.
- Derived from this study: PubMed 34384490Alosco ML, Mariani ML, Adler CH, Balcer LJ, Bernick C, Au R, Banks SJ, Barr WB, Bouix S, Cantu RC, Coleman MJ, Dodick DW, Farrer LA, Geda YE, Katz DI, Koerte IK, Kowall NW, Lin AP, Marcus DS, Marek KL, McClean MD, McKee AC, Mez J, Palmisano JN, Peskind ER, Tripodis Y, Turner RW 2nd, Wethe JV, Cummings JL, Reiman EM, Shenton ME, Stern RA; DIAGNOSE CTE Research Project Investigators. Developing methods to detect and diagnose chronic traumatic encephalopathy during life: rationale, design, and methodology for the DIAGNOSE CTE Research Project. Alzheimers Res Ther. 2021 Aug 12;13(1):136. doi: 10.1186/s13195-021-00872-x.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with FITBIR and other data sharing portals
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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.
Robert A Stern, PhD principal investigator
Boston University
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 Chronic Traumatic Encephalopathy, run by Boston University at 1 site in United States.
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 51 inclusion and 0 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Neuroimaging Positron Emission Tomography for Amyloid Biomarker (time frame: One-Time). The study lists 7 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 NCT02798185, which also lists 3 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 5 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.