Dementia AlzheimersLDIR-CT-ADNCT03597360
Low Dose Ionizing Radiation Using CT Scans as a Potential Therapy for Alzheimer's Dementia: A Pilot Study
A study testing CT scan in people with Dementia Alzheimers, run by Baycrest at 1 site in Canada.
Trial summary
The goal of this project is to determine whether low doses of ionizing radiation (LDIR) from repeat CT scanning improves function, cognition and/or behavior in severe AD. Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Dementia Alzheimers
- What is being tested?
- CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2019to 1 Apr 2020
- 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 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Males or females with severe AD dementia (MMSE<12) between the ages of 70 to 90 years.
- Meet the criteria of AD (NIA-AA).
- If on any of the following medications: acetylcholinesterase inhibitors and/or memantine, participants must be on a stable dose for at least 60 days.
- Clinically stable for at least 3 months.
Who cannot join
- Current or past history of malignancy.
- Previous history of radiotherapy.
- Neurological disorder other than AD.
- Currently receiving other experimental treatments.
- Clinical or imaging evidence of stroke (with more than 1-2 lacunar infarcts on CT scan or MRI).
- Major depression, bipolar affective disorder or psychosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Ionizing Radiation Using CT Scans as a Potential Therapy for Alzheimer's Dementia (LDIR-CT-AD) Trial: A Pilot Study
The goal of this project is to determine whether low doses of ionizing radiation (LDIR) from repeat CT scanning improves function, cognition and/or behavior in severe AD.
Read the detailed description
Alzheimer's dementia (AD) is a disorder of uncertain cause and pathogenesis that primarily affects older adults. It accounts for more than 50 percent of cases of dementia in the elderly and is a leading source of morbidity and mortality in the aging population. The most essential and often earliest symptom is selective memory impairment. While treatments can improve some symptoms, there is no cure or disease-modifying therapy, and the disease inevitably progresses in all patients. The mainstay of management is still symptomatic treatment of behavioral disturbances, environmental manipulations to prevent behavioural disturbances, and counseling with respect to safety issues.
The goal of this project is to determine whether low doses of ionizing radiation (LDIR) from repeat CT scanning improves function, cognition and/or behavior in severe AD. This is based upon the treatments given in 2015 to a patient in hospice in the USA with advanced AD. On July 23, she received two CT scans of her brain. Two weeks later she received a third CT scan, and two weeks after this, a fourth CT scan. She partially improved and was discharged to an Alzheimer care home.
In terms of the mechanism whereby CT scanning might lead to improvement, reactive oxygen species (ROS) are produced abundantly and constantly by aerobic metabolism in all organisms, damaging biomolecules including those in the brain. AD is postulated to be caused by the accumulation of oxidative stress damage in the brain that was not prevented, repaired or removed by the patient's own biological protective mechanisms. These systems, characterized genetically, operate against all toxins regardless of whether they are produced endogenously or by external physical, chemical or biological agents. As people age, their protection systems become progressively weaker. LDIR is postulated to stimulate adaptive protection systems. This may produce beneficial effects including improvement in AD symptoms. With about three-quarters of human tissue being water, most of the initial radiation-induced damage is radiolysis of water, producing ROS and hydrogen peroxide (H2O2). LDIR leads to mild oxidative stress and strong signaling, which up-regulates protection.The degree of stimulation likely depends upon individual genetic factors.
CT scans are approved for clinical diagnostic imaging. Approval will be requested from the Research Ethics Board (REB) at Baycrest Health Sciences and from Health Canada to use CT scanning for the experimental treatment of AD. If this pilot study is successful, i.e., if improvement is observed in the participants, then a proposal will be prepared for more comprehensive clinical studies of this novel treatment.
- Conditions
- Dementia Alzheimers
- Being tested
- CT scan
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanRadiation
Participants will receive the first LDIR treatment in one session on the same day, i.e., two CT scans of the brain that delivers a total X-ray dose (CTDIvol)10 of about 80 mGy. Participants will then be transported back to Baycrest Health Sciences. Participants will receive another LDIR treatment, i.e. a single CT scan of the brain (40 mGy), 2 weeks after the first session. They will receive a third LDIR treatment, i.e., a single CT scan of the brain (40 mGy), 2 weeks after the second session. Date, time and X-ray dose will be recorded for each participant and sent to their family physician for entry into in their health record.
| Study group | Role | What they receive |
|---|---|---|
| CT scan subjects | Experimental | Three participants with severe Alzheimer's dementia will be studied Receives: Radiation: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer Disease Functional Assessment and Change Scale (ADFACS)
is a specific scale for the functional assessment of people with Alzheimer Disease. A number of specific descriptions of performance levels for each item is offered, and the caregiver is asked to identify the one that most accurately describes the patient's performance . The scale consists of 16 items for the assessment of ADL, i.e. 6 items for BADL, 10 for IADL. items are scored from 0 to 4: 0 = no impairment, 1 = mild impairment, 2 = moderate impairment, 3 = severe impairment and 4 = nonassessable, with a range from 0 to 30. BADL items are scored from 0 to 5: 0 = no impairment, 1 = mild impairment, 2 = moderate impairment, 3 = severe impairment, 4 = very severe impairment and 5 = nonassessable, with a range from 0 to 24. In each part, the 'nonassessable' answer is substituted by an estimation from the average of the responded items. The total score (IADL + BADL) ranges from 0 to 54 (from best to worst).
Measured: 20 minutes
Secondary outcomes (2)
Severe Impairment Battery (SIB)
to assess cognition
Measured: 30 minutes
Cohen-Mansfield Agitation Index (CMAI)
The Cohen-Mansfield Agitation Index (CMAI) is a caregivers' rating questionnaire consisting of 29 agitated behaviours, each rated on a 7-point scale of frequency. It assesses the frequency of agitated behaviours in elderly persons in the long-term care setting.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start8 Jan 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Dementia AlzheimersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerry M Cuttler, Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597360
- Sponsor's protocol ID
- Baycrest REB # 18-02
- Acronym
- LDIR-CT-AD
- Status last verified
- Feb 2022
- First submitted
- 10 Jul 2018
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The purpose of the information disclosure is for review by a research ethics board committee only, and is of a privileged and confidential nature.
Publications
Ballard C, Gauthier S, Corbett A, Brayne C, Aarsland D, Jones E. Alzheimer's disease. Lancet. 2011 Mar 19;377(9770):1019-31. doi: 10.1016/S0140-6736(10)61349-9. Epub 2011 Mar 1.
PubMed 21371747Cuttler JM, Moore ER, Hosfeld VD, Nadolski DL. Treatment of Alzheimer Disease With CT Scans: A Case Report. Dose Response. 2016 Apr 1;14(2):1559325816640073. doi: 10.1177/1559325816640073. eCollection 2016 Apr-Jun.
PubMed 27103883Cuttler JM, Moore ER, Hosfeld VD, Nadolski DL. Update on a Patient With Alzheimer Disease Treated With CT Scans. Dose Response. 2017 Feb 17;15(1):1559325817693167. doi: 10.1177/1559325817693167. eCollection 2017 Jan-Mar. No abstract available.
PubMed 28321176Pollycove M, Feinendegen LE. Radiation-induced versus endogenous DNA damage: possible effect of inducible protective responses in mitigating endogenous damage. Hum Exp Toxicol. 2003 Jun;22(6):290-306; discussion 307, 315-7, 319-23. doi: 10.1191/0960327103ht365oa.
PubMed 12856953Sies H, Berndt C, Jones DP. Oxidative Stress. Annu Rev Biochem. 2017 Jun 20;86:715-748. doi: 10.1146/annurev-biochem-061516-045037. Epub 2017 Apr 24.
PubMed 28441057Feinendegen LE, Pollycove M, Neumann RD. Low-dose cancer risk modeling must recognize up-regulation of protection. Dose Response. 2009 Dec 10;8(2):227-52. doi: 10.2203/dose-response.09-035.Feinendegen.
PubMed 20585440Sies H. Hydrogen peroxide as a central redox signaling molecule in physiological oxidative stress: Oxidative eustress. Redox Biol. 2017 Apr;11:613-619. doi: 10.1016/j.redox.2016.12.035. Epub 2017 Jan 5.
PubMed 28110218Sies H, Feinendegen LE. Radiation Hormesis: The Link to Nanomolar Hydrogen Peroxide. Antioxid Redox Signal. 2017 Sep 20;27(9):596-598. doi: 10.1089/ars.2017.7233. Epub 2017 Aug 7.
PubMed 28699353Feinendegen LE, Cuttler JM. Biological Effects From Low Doses and Dose Rates of Ionizing Radiation: Science in the Service of Protecting Humans, a Synopsis. Health Phys. 2018 Jun;114(6):623-626. doi: 10.1097/HP.0000000000000833.
PubMed 29521814Manero RM, Casals-Coll M, Sanchez-Benavides G, Rodriguez-de los Reyes ON, Aguilar M, Badenes D, Molinuevo JL, Robles A, Barquero MS, Antunez C, Martinez-Parra C, Frank-Garcia A, Fernandez M, Blesa R, Pena-Casanova J; NEURONORMA Study Team. Diagnostic validity of the Alzheimer's disease functional assessment and change scale in mild cognitive impairment and mild to moderate Alzheimer's disease. Dement Geriatr Cogn Disord. 2014;37(5-6):366-75. doi: 10.1159/000350800. Epub 2014 Feb 18.
PubMed 24556708Panisset M, Roudier M, Saxton J, Boller F. Severe impairment battery. A neuropsychological test for severely demented patients. Arch Neurol. 1994 Jan;51(1):41-5. doi: 10.1001/archneur.1994.00540130067012.
PubMed 8274108Cohen-Mansfield J. Agitated behaviors in the elderly. II. Preliminary results in the cognitively deteriorated. J Am Geriatr Soc. 1986 Oct;34(10):722-7. doi: 10.1111/j.1532-5415.1986.tb04303.x.
PubMed 3760436Jack CR Jr, Albert MS, Knopman DS, McKhann GM, Sperling RA, Carrillo MC, Thies B, Phelps CH. Introduction to the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):257-62. doi: 10.1016/j.jalz.2011.03.004. Epub 2011 Apr 21.
PubMed 21514247Sakamoto K. Radiobiological basis for cancer therapy by total or half-body irradiation. Nonlinearity Biol Toxicol Med. 2004 Oct;2(4):293-316. doi: 10.1080/15401420490900254.
PubMed 19330149Pollycove M. Radiobiological basis of low-dose irradiation in prevention and therapy of cancer. Dose Response. 2006 Nov 27;5(1):26-38. doi: 10.2203/dose-response.06-112.Pollycove.
PubMed 18648556
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Ionizing Radiation Using CT Scans as a Potential Therapy for Alzheimer's Dementia (LDIR-CT-AD) Trial: A Pilot Study
- ClinicalTrials.gov ID
- NCT03597360
- Acronym / sponsor ID
- LDIR-CT-AD / Baycrest REB # 18-02
- Conditions
- Dementia Alzheimers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 24 Jul 2018 (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.
The goal of this project is to determine whether low doses of ionizing radiation (LDIR) from repeat CT scanning improves function, cognition and/or behavior in severe AD.
Detailed description
Alzheimer's dementia (AD) is a disorder of uncertain cause and pathogenesis that primarily affects older adults. It accounts for more than 50 percent of cases of dementia in the elderly and is a leading source of morbidity and mortality in the aging population. The most essential and often earliest symptom is selective memory impairment. While treatments can improve some symptoms, there is no cure or disease-modifying therapy, and the disease inevitably progresses in all patients. The mainstay of management is still symptomatic treatment of behavioral disturbances, environmental manipulations to prevent behavioural disturbances, and counseling with respect to safety issues.
The goal of this project is to determine whether low doses of ionizing radiation (LDIR) from repeat CT scanning improves function, cognition and/or behavior in severe AD. This is based upon the treatments given in 2015 to a patient in hospice in the USA with advanced AD. On July 23, she received two CT scans of her brain. Two weeks later she received a third CT scan, and two weeks after this, a fourth CT scan. She partially improved and was discharged to an Alzheimer care home.
In terms of the mechanism whereby CT scanning might lead to improvement, reactive oxygen species (ROS) are produced abundantly and constantly by aerobic metabolism in all organisms, damaging biomolecules including those in the brain. AD is postulated to be caused by the accumulation of oxidative stress damage in the brain that was not prevented, repaired or removed by the patient's own biological protective mechanisms. These systems, characterized genetically, operate against all toxins regardless of whether they are produced endogenously or by external physical, chemical or biological agents. As people age, their protection systems become progressively weaker. LDIR is postulated to stimulate adaptive protection systems. This may produce beneficial effects including improvement in AD symptoms. With about three-quarters of human tissue being water, most of the initial radiation-induced damage is radiolysis of water, producing ROS and hydrogen peroxide (H2O2). LDIR leads to mild oxidative stress and strong signaling, which up-regulates protection.The degree of stimulation likely depends upon individual genetic factors.
CT scans are approved for clinical diagnostic imaging. Approval will be requested from the Research Ethics Board (REB) at Baycrest Health Sciences and from Health Canada to use CT scanning for the experimental treatment of AD. If this pilot study is successful, i.e., if improvement is observed in the participants, then a proposal will be prepared for more comprehensive clinical studies of this novel treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT scan subjects | Experimental | Radiation: CT scanThree participants with severe Alzheimer's dementia will be studied |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Males or females with severe AD dementia (MMSE<12) between the ages of 70 to 90 years.
- Meet the criteria of AD (NIA-AA).
- If on any of the following medications: acetylcholinesterase inhibitors and/or memantine, participants must be on a stable dose for at least 60 days.
- Clinically stable for at least 3 months.
Key exclusion criteria (6 listed)
- Current or past history of malignancy.
- Previous history of radiotherapy.
- Neurological disorder other than AD.
- Currently receiving other experimental treatments.
- Clinical or imaging evidence of stroke (with more than 1-2 lacunar infarcts on CT scan or MRI).
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 |
|---|---|---|
| CT scanParticipants will receive the first LDIR treatment in one session on the same day, i.e., two CT scans of the brain that delivers a total X-ray dose (CTDIvol)10 of about 80 mGy. Participants will then be transported back to Baycrest Health Sciences. Participants will receive another LDIR treatment, i.e. a single CT scan of the brain (40 mGy), 2 weeks after the first session. They will receive a third LDIR treatment, i.e., a single CT scan of the brain (40 mGy), 2 weeks after the second session. Date, time and X-ray dose will be recorded for each participant and sent to their family physician for entry into in their health record. | Radiation | CT scan subjects |
Primary outcome
Alzheimer Disease Functional Assessment and Change Scale (ADFACS)
Time frame: 20 minutes
is a specific scale for the functional assessment of people with Alzheimer Disease. A number of specific descriptions of performance levels for each item is offered, and the caregiver is asked to identify the one that most accurately describes the patient's performance . The scale consists of 16 items for the assessment of ADL, i.e. 6 items for BADL, 10 for IADL. items are scored from 0 to 4: 0 = no impairment, 1 = mild impairment, 2 = moderate impairment, 3 = severe impairment and 4 = nonassessable, with a range from 0 to 30. BADL items are scored from 0 to 5: 0 = no impairment, 1 = mild impairment, 2 = moderate impairment, 3 = severe impairment, 4 = very severe impairment and 5 = nonassessable, with a range from 0 to 24. In each part, the 'nonassessable' answer is substituted by an estimation from the average of the responded items. The total score (IADL + BADL) ranges from 0 to 54 (from best to worst).
2 secondary outcomes
Severe Impairment Battery (SIB)
Time frame: 30 minutes
Cohen-Mansfield Agitation Index (CMAI)
Time frame: 30 minutes
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 Mar 2022.
- Results publication: PubMed 21371747Ballard C, Gauthier S, Corbett A, Brayne C, Aarsland D, Jones E. Alzheimer's disease. Lancet. 2011 Mar 19;377(9770):1019-31. doi: 10.1016/S0140-6736(10)61349-9. Epub 2011 Mar 1.
- Results publication: PubMed 27103883Cuttler JM, Moore ER, Hosfeld VD, Nadolski DL. Treatment of Alzheimer Disease With CT Scans: A Case Report. Dose Response. 2016 Apr 1;14(2):1559325816640073. doi: 10.1177/1559325816640073. eCollection 2016 Apr-Jun.
- Results publication: PubMed 28321176Cuttler JM, Moore ER, Hosfeld VD, Nadolski DL. Update on a Patient With Alzheimer Disease Treated With CT Scans. Dose Response. 2017 Feb 17;15(1):1559325817693167. doi: 10.1177/1559325817693167. eCollection 2017 Jan-Mar. No abstract available.
- Results publication: PubMed 12856953Pollycove M, Feinendegen LE. Radiation-induced versus endogenous DNA damage: possible effect of inducible protective responses in mitigating endogenous damage. Hum Exp Toxicol. 2003 Jun;22(6):290-306; discussion 307, 315-7, 319-23. doi: 10.1191/0960327103ht365oa.
- Results publication: PubMed 28441057Sies H, Berndt C, Jones DP. Oxidative Stress. Annu Rev Biochem. 2017 Jun 20;86:715-748. doi: 10.1146/annurev-biochem-061516-045037. Epub 2017 Apr 24.
- Results publication: PubMed 20585440Feinendegen LE, Pollycove M, Neumann RD. Low-dose cancer risk modeling must recognize up-regulation of protection. Dose Response. 2009 Dec 10;8(2):227-52. doi: 10.2203/dose-response.09-035.Feinendegen.
- Results publication: PubMed 28110218Sies H. Hydrogen peroxide as a central redox signaling molecule in physiological oxidative stress: Oxidative eustress. Redox Biol. 2017 Apr;11:613-619. doi: 10.1016/j.redox.2016.12.035. Epub 2017 Jan 5.
- Results publication: PubMed 28699353Sies H, Feinendegen LE. Radiation Hormesis: The Link to Nanomolar Hydrogen Peroxide. Antioxid Redox Signal. 2017 Sep 20;27(9):596-598. doi: 10.1089/ars.2017.7233. Epub 2017 Aug 7.
- Results publication: PubMed 29521814Feinendegen LE, Cuttler JM. Biological Effects From Low Doses and Dose Rates of Ionizing Radiation: Science in the Service of Protecting Humans, a Synopsis. Health Phys. 2018 Jun;114(6):623-626. doi: 10.1097/HP.0000000000000833.
- Results publication: PubMed 24556708Manero RM, Casals-Coll M, Sanchez-Benavides G, Rodriguez-de los Reyes ON, Aguilar M, Badenes D, Molinuevo JL, Robles A, Barquero MS, Antunez C, Martinez-Parra C, Frank-Garcia A, Fernandez M, Blesa R, Pena-Casanova J; NEURONORMA Study Team. Diagnostic validity of the Alzheimer's disease functional assessment and change scale in mild cognitive impairment and mild to moderate Alzheimer's disease. Dement Geriatr Cogn Disord. 2014;37(5-6):366-75. doi: 10.1159/000350800. Epub 2014 Feb 18.
- Results publication: PubMed 8274108Panisset M, Roudier M, Saxton J, Boller F. Severe impairment battery. A neuropsychological test for severely demented patients. Arch Neurol. 1994 Jan;51(1):41-5. doi: 10.1001/archneur.1994.00540130067012.
- Results publication: PubMed 3760436Cohen-Mansfield J. Agitated behaviors in the elderly. II. Preliminary results in the cognitively deteriorated. J Am Geriatr Soc. 1986 Oct;34(10):722-7. doi: 10.1111/j.1532-5415.1986.tb04303.x.
- Individual participant dataSharing planned: No. The purpose of the information disclosure is for review by a research ethics board committee only, and is of a privileged and confidential nature.
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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 CT scan in people with Dementia Alzheimers, run by Baycrest 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 4 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 2 Mar 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 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.
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?
Alzheimer Disease Functional Assessment and Change Scale (ADFACS) (time frame: 20 minutes). 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 NCT03597360, which also lists 17 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 2 Mar 2022.