Alzheimer DiseasePhase 2/3NCT03823404
GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease
A Phase 2/3 study testing COR388 capsule in people with Alzheimer Disease, run by Cortexyme Inc. at 93 sites in 6 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease (AD) dementia. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- COR388 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 643 participants
- Where
- 93 sitesin 6 countries
- Study dates
- 28 Mar 2019to 1 Jan 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has probable AD dementia according to the NIA-AA criteria.
- Subject has an Mini-Mental State Examination (MMSE) score 12 and 24 inclusive at both screening and Visit 2 and a ≤3-point difference between these visits.
- Subject has brain MRI scan consistent with the diagnosis of AD performed during the screening period. Computed Tomography scan can be used only if the subject has an absolute contraindication for MRI.
- Subject has a Modified Hachinski score ≤4 at screening.
- Subjects with background symptomatic therapy with acetylcholine esterase inhibitors, and/or memantine, are allowed as long as the dose has been stable for 90 days prior to screening and no changes are planned during the study.
- Subject has a primary caregiver willing to accept responsibility for supervising the treatment (e.g., administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.
- Subject has body mass index <38 kg/m2 at Screening
Who cannot join
- Subject has imaging consistent with a dementia diagnosis other than AD.
- Subject has had an increase or restoration of cognition based on medical history.
- Subject with history or current evidence of major psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder that may interfere with the patient's ability to perform the study and all assessments. Note: Mild depression or depressive mood arising in the context of AD are not criteria for exclusion. The use of anti-depressants or the use of anti epileptic medication for non seizure-related treatment is allowed if the dose has remained stable for at least 60 days prior to enrollment.
- Subject has any of the following laboratory findings at screening:
- Alanine aminotransferase >3 x upper limit of normal (ULN), aspartate aminotransferase >3 x ULN, or history of clinically significant liver disease in the Investigator's judgment.
- Hemoglobin ≤10 g/dl.
Show all 9Show fewer
- Creatinine clearance (CL) of <45 ml/min.
- Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) >8.
- Positive blood screen for Human Immunodeficiency Virus (HIV 1 and 2), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus antibodies (HCV-Ab) at Screening.
Trial locations and contacts
93 sites in 6 countries.
93 sites in 6 countries
United States58 sites
Disease Research & Neurology Center of Neurological Associates of Albany
Albany, New York, 12208
Albuquerque Neuroscience
Albuquerque, New Mexico, 87109
JEM Research Institute
Atlantis, Florida, 33462
Senior Adults Specialty Research
Austin, Texas, 78757
Insight Clinical Trials, LLC
Beachwood, Ohio, 44122
Northwest Clinical Research Center
Bellevue, Washington, 98007
Northwest Clinical Trials
Boise, Idaho, 83704
Integrative Clinical Trials LLC
Brooklyn, New York, 11229
Spri Clinicaltrials, Llc
Brooklyn, New York, 11235
ANI Neurology, PLLC dba Alzheimer's Memory Center
Charlotte, North Carolina, 28270
University of Virginia Adult Neurology
Charlottesville, Virginia, 22903
Columus Memory Center
Columbus, Georgia, 31909
ATP Clinical Research, Inc.
Costa Mesa, California, 92626
Kerwin Research Center
Dallas, Texas, 75231
Neurology Consultants of Dallas
Dallas, Texas, 75243
Neurology Diagnostics Inc.
Dayton, Ohio, 45459
NeuroStudies.net, LLC
Decatur, Georgia, 30033
Brain Matters Research
Delray Beach, Florida, 33445
Alexian Brothers Neurosciences Research
Elk Grove Village, Illinois, 60007
Recognition Health
Fairfax, Virginia, 22031
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
MD Clinical
Hallandale, Florida, 33009
Memory Center
Hattiesburg, Mississippi, 39401
Indago Research and Health Center, Inc.
Hialeah, Florida, 33012
Houston Methodist Department of Neurology
Houston, Texas, 77030
Clinical Trial Network
Houston, Texas, 77074
Alzheimer's Research and Treatment Center
Lake Worth, Florida, 33449
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106
Alliance Research
Long Beach, California, 90807
Activmed Practices and Research
Methuen, Massachusetts, 01844
Qtrials, Inc.
Miami, Florida, 33144
Future Care Solutions, LLC
Miami, Florida, 33165
Miami Dade Medical Research Institute
Miami, Florida, 33176
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226
Mid Hudson Medical Research
New Windsor, New York, 12553
The Boston Center for Memory
Newton, Massachusetts, 02459
Sensible Healthcare LLC
Ocoee, Florida, 34761
Bioclinica Research
Orlando, Florida, 32806
Standford University
Palo Alto, California, 94305
Anchor Neuroscience
Pensacola, Florida, 32502
Xenoscience, Inc.
Phoenix, Arizona, 85004
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Northeastern Pennsylvania Memory and Alzheimer's Center
Plains, Pennsylvania, 18507
Memory Health Center at Summit Research Network
Portland, Oregon, 97210
Princeton Medical Institute
Princeton, New Jersey, 08540
Anil Nair MD, Alzheimer's Disease Center
Quincy, Massachusetts, 02169
CITRIALS
Riverside, California, 92506
CITRIALS
Santa Ana, California, 92705
Syrentis Clinical Research
Santa Ana, California, 92705
UW Alzheimer's Disease Research Center
Seattle, Washington, 98104
Southern California Research LLC
Simi Valley, California, 93065
The Cognitive Research Center of New Jersey
Springfield, New Jersey, 07081
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33713
Brain Matters Research at the Kane Center
Stuart, Florida, 34997
Banner Sun Health
Sun City, Arizona, 85351
Stedman Clinical Trials
Tampa, Florida, 33613
Neurology Specialists of Monmouth County
West Long Branch, New Jersey, 07764
Ascension Via Christi Research
Wichita, Kansas, 67214
United Kingdom9 sites
St Pancras Clinical Research (private)
Barbican, London, EC2Y 8EA
RICE - The Research Institute for the Care of Older People
Bath, BA1 3NG
Cognition Health Birmingham (private)
Edgbaston, Birmingham, B16 8LT
Glasgow Memory Clinic
Glasgow, G20 0XA
Cognition Health Ltd. (private) Guildford
Guildford, GU2 7YD
Cognition Health Ltd. (private) London
London, W1G 9JF
Cognition Health Plymouth
Plymouth, Science Park, PL5 8BT
Memory Assessment and Research Centre, Moorgreen Hospital
Southampton, UK, SO30 3JB
Kingshill Research Centre Swindon
Swindon, SN3 6BW
Spain8 sites
Hospital General de Alicante
Alicante, 03010
Hospital de la Santa Creu i Sant Pau
Barcelona, 8005
Fundacio Ace
Barcelona, 8028
Hospital Clinic de Barcelona
Barcelona, 8036
Hospital Universitario Ramón Y Cajal
Madrid, 28034
Policlinica Gipuzkoa
San Sebastián, Gipuzkoa, 20014
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, 8195
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Poland7 sites
Indywidualna Specjalistyczna Praktyka Lekarska
Gdansk, 80-438
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Katowice, 40-123
Krakowska Akademia Neurologii
Krakow, 31-505
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Siemianowice Śląskie, 41-100
Euromedis Sp. z o.o.
Szczecin, 70-111
Centrum Medyczne NeuroProtect
Warsaw, 01-684
NZOZ Wrocławskie Centrum Alzheimerowskie
Wroclaw, 53-659
France6 sites
Centre de Ressources Biologiques
Lille, 59037
University Hospital La Timone, Department of Neurology and Neuropsychology
Marseille, 13385
Service de Gériatrie
Nice, 6100
Hôpitaux Universitaires de Strasbourg, Centre d'Investigation Clinique, Hôpital Hautepierre
Strasbourg, 67098
Hôpital de Brabois
Toulouse, Cedex, 31059
CHRU de Nancy Hôpital de Brabois Service de Gériatrie
Vandœuvre-lès-Nancy, 54500
Netherlands5 sites
Brain Research Center Den Bosch B.V.
's-Hertogenbosch, 5223 LA
Brain Research Center
Amsterdam, 1081 GN
PreCare Trial & Recruitment
Beek, 6191 JW
Isala Zwolle - Interne geneeskunde Centrum voor ouderengeneeskunde
Zwolle, 8025 AB
Brain Research Center Zwolle
Zwolle, 8025 AZ
About this study
Official title: GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease
This is a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease (AD) dementia.
Read the detailed description
This was a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 oral capsules in subjects with probable Alzheimer's disease (AD) dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. The subject did not have other conditions or brain imaging abnormalities that could explain the symptoms of dementia. All subjects were encouraged to have lumbar punctures (LPs) (during screening, week 24 and week 48) in the absence of medical conditions that could increase the risk of the procedure in the opinion of the Investigator. Cerebrospinal fluid (CSF), saliva, and blood were analyzed for measurements of biomarkers of AD and neuroinflammation, and for the presence of bacterial deoxyribonucleic acid (DNA) of Porphyromonas gingivalis (P. gingivalis). A subset of sites monitored subjects for clinical evidence of periodontitis at baseline, 24 and 48 weeks.
The study consisted of 3 phases: a screening phase of up to 6 weeks, a treatment phase of up to 48 weeks, and a safety follow-up phase of 6 weeks.
- Conditions
- Alzheimer Disease
- Being tested
- COR388 capsule, Placebo capsule
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COR388 capsuleDrug
Also called atuzaginstat
BID (twice daily)
Placebo capsuleDrug
Also called atuzaginstat
BID
| Study group | Role | What they receive |
|---|---|---|
| COR388 80 mg twice daily (BID) | Experimental | COR388 hydrochloric acid (HCl), 80 mg orally administered capsule, BID (twice daily) with water approximately 12 hours apart and no less than 6 hours apart Receives: Drug: COR388 capsule |
| COR388 40 mg BID | Experimental | COR388 HCl, 40 mg orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart Receives: Drug: COR388 capsule |
| Placebo BID | Placebo comparator | Placebo orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity.
Measured: Baseline to Week 48
Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory.
The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.
Measured: Baseline to Week 48
Secondary outcomes (3)
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.
Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Measured: Baseline to Week 48
Mini-Mental State Examination (MMSE)
Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0 Maximum Score - 30 Higher score means better outcome
Measured: Baseline to Week 48
Neuropsychiatric Inventory (NPI)
Neuropsychiatric Inventory (NPI) - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders.
Total score ranges from 12 to 144; higher scores indicate greater disease severity.
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start28 Mar 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cortexyme Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Smith, MD, Study director, Quince Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823404
- Sponsor's protocol ID
- COR388-010
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2019
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03823404
- Acronym / sponsor ID
- COR388-010
- Conditions
- Alzheimer Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Cortexyme Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Posted 23 Feb 2023
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 randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease (AD) dementia.
Detailed description
This was a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 oral capsules in subjects with probable Alzheimer's disease (AD) dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. The subject did not have other conditions or brain imaging abnormalities that could explain the symptoms of dementia. All subjects were encouraged to have lumbar punctures (LPs) (during screening, week 24 and week 48) in the absence of medical conditions that could increase the risk of the procedure in the opinion of the Investigator. Cerebrospinal fluid (CSF), saliva, and blood were analyzed for measurements of biomarkers of AD and neuroinflammation, and for the presence of bacterial deoxyribonucleic acid (DNA) of Porphyromonas gingivalis (P. gingivalis). A subset of sites monitored subjects for clinical evidence of periodontitis at baseline, 24 and 48 weeks.
The study consisted of 3 phases: a screening phase of up to 6 weeks, a treatment phase of up to 48 weeks, and a safety follow-up phase of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COR388 80 mg twice daily (BID) | Experimental | Drug: COR388 capsuleCOR388 hydrochloric acid (HCl), 80 mg orally administered capsule, BID (twice daily) with water approximately 12 hours apart and no less than 6 hours apart |
| COR388 40 mg BID | Experimental | Drug: COR388 capsuleCOR388 HCl, 40 mg orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart |
| Placebo BID | Placebo comparator | Drug: Placebo capsulePlacebo orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has probable AD dementia according to the NIA-AA criteria.
- Subject has an Mini-Mental State Examination (MMSE) score 12 and 24 inclusive at both screening and Visit 2 and a ≤3-point difference between these visits.
- Subject has brain MRI scan consistent with the diagnosis of AD performed during the screening period. Computed Tomography scan can be used only if the subject has an absolute contraindication for MRI.
- Subject has a Modified Hachinski score ≤4 at screening.
- Subjects with background symptomatic therapy with acetylcholine esterase inhibitors, and/or memantine, are allowed as long as the dose has been stable for 90 days prior to screening and no changes are planned during the study.
Key exclusion criteria (9 listed)
- Subject has imaging consistent with a dementia diagnosis other than AD.
- Subject has had an increase or restoration of cognition based on medical history.
- Subject with history or current evidence of major psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder that may interfere with the patient's ability to perform the study and all assessments. Note: Mild depression or depressive mood arising in the context of AD are not criteria for exclusion. The use of anti-depressants or the use of anti epileptic medication for non seizure-related treatment is allowed if the dose has remained stable for at least 60 days prior to enrollment.
- Subject has any of the following laboratory findings at screening:
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 |
|---|---|---|
| COR388 capsuleAlso: atuzaginstatBID (twice daily) | Drug | COR388 40 mg BID, COR388 80 mg twice daily (BID) |
| Placebo capsuleAlso: atuzaginstatBID | Drug | Placebo BID |
Primary outcome
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
Time frame: Baseline to Week 48
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity.
Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
Time frame: Baseline to Week 48
The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory. The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.
3 secondary outcomes
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Time frame: Baseline to Week 48
Mini-Mental State Examination (MMSE)
Time frame: Baseline to Week 48
Neuropsychiatric Inventory (NPI)
Time frame: Baseline to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Karen Smith, MD study director
Quince Therapeutics Inc
93 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing COR388 capsule in people with Alzheimer Disease, run by Cortexyme Inc. at 93 sites in 6 countries.
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 7 inclusion and 9 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 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, United Kingdom, Spain, Poland, France and 1 more country. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) (time frame: Baseline to Week 48). 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 23 Feb 2023.