Mild to Moderate Alzheimer's DiseasePhase 2NCT03507790
A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
A Phase 2 study testing CT1812 in people with Mild to Moderate Alzheimer's Disease, run by Cognition Therapeutics at 32 sites in 5 countries.
Trial summary
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild to Moderate Alzheimer's Disease
- What is being tested?
- CT1812
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 32 sitesin 5 countries
- Study dates
- 10 Oct 2018to 29 May 2024
- Phase
- Phase 2
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.
- Non-childbearing potential for women is defined as postmenopausal (last natural menses greater than 24 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 24 months, a serum FSH value confirming post-menopausal status can be employed.
- Male participants who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for 3 months after last dose unless the woman is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap.
- Diagnostic confirmation by amyloid PET with florbetaben or another approved amyloid PET ligand. Previous amyloid imaging study with a positive result will be accepted. If none is available, then amyloid PET will be conducted during screening. Diagnostic confirmation by a CSF sample collected at the screening visit lumbar puncture in place of amyloid PET will also be acceptable
- Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease and without findings of significant exclusionary abnormalities (see exclusion criteria, number 4). An historical MRI, up to 1 year prior to screening, may be used as long as there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs suggestive of such intervening events.).
- MMSE 18-26 inclusive.
Who cannot join
- Screening MRI (or historical MRI, if applicable) of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct >1 cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility..
- Clinical or laboratory findings consistent with:
- Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
- Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
- Seizure disorder.
- Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
- A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder. Subjects with depressive symptoms successfully managed by a stable dose of an antidepressant are allowed entry.
- Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.
Trial locations and contacts
32 sites in 5 countries.
32 sites in 5 countries
United States12 sites
JEM Research Institute
Atlantis, Florida, 33462
Alzheimer's Memory Center
Charlotte, North Carolina, 28270
The Ohio State University - Wexner
Columbus, Ohio, 43221-3502
Charter Research
Lady Lake, Florida, 32159
ClinCloud, LLC
Maitland, Florida, 32751
Allied Biomedical Research Institute
Miami, Florida, 33155
Neuro Behavirol Clinical Research C
North Canton, Ohio, 44720
21st Century Neurology/ Xenoscience Inc.
Phoenix, Arizona, 85004
Imaging Endpoints
Scottsdale, Arizona, 85258
Ki Health Partners, LLC dba New England Institute for Clinical Research
Stamford, Connecticut, 06905
Compass Research LLC- Bioclinica Research
The Villages, Florida, 32162
ClinCloud
Viera, Florida, 32940
Czechia8 sites
Neuro Health Centrum ltd
Brno, 628 00
NeuropsychiatrieHK S.R.O
Hradec Králové, 503 41
A-Shine S.R.O
Pilsen, 30100
Clintrial S.R.O
Prague, 100 00
Neuropsychiatrie s.r.o.
Prague, 16 000
Forbeli S.R.O
Prague, 160 00
INEP
Prague, 18600
Vestra Clinics
Rychnov nad Kněžnou, 51601
Spain5 sites
Fundación ACE
Barcelona, 08028
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, 30120
Centro de Salud San Juan
Salamanca, 37005
Hospital Victoria EUGENIA. Unidad de Neurociencias.
Seville, 41009
Fundación Neuropolis - Hospital Viamed Montecanal
Zaragoza, 5000
Australia4 sites
St Vincent's Hospital Sydney
Ivanhoe, Victoria, 3079
Alfred Health
Melbourne, Victoria, 3004
Australian Alzheimer's Research Foundation
Nedlands, Western Australia, 6009
Melbourne Health
Parkville, Victoria, 3050
Netherlands3 sites
Brain Research Den Bosch
's-Hertogenbosch, 5223 LA
Brain Research Center Amsterdam
Amsterdam, 1081 GN
Brain Research Center Zwolle
Zwolle, 8025 AZ
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).
Read the detailed description
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).
This Phase 2 study is designed to evaluate the safety of two doses of CT1812 administered once daily for 6 months in adults aged 50 to 85 who have been diagnosed with mild to moderate Alzheimer's disease. Randomized participants will receive 100 mg of CT1812, 300 mg of CT1812, or placebo once daily for 182 days. Exploratory endpoints that evaluate the effect of CT1812 on biomarkers are also included.
- Conditions
- Mild to Moderate Alzheimer's Disease
- Being tested
- CT1812, Placebo
- Keywords
- Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT1812Drug
Also called Study Drug, zervimesine
Active Study Drug
PlaceboDrug
Also called Matching Placebo
Non-active study drug
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment- CT1812 100 mg | Active comparator | CT1812 at a dose of 100 mg Receives: Drug: CT1812 |
| Active Treatment- CT1812 300 mg | Active comparator | CT1812 at a dose of 300mg Receives: Drug: CT1812 |
| Placebo Comparator - Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)
Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).
Measured: Up to 210 Days
Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs).
Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).
Measured: Up to 210 Days
Secondary outcomes (2)
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers
Change from baseline in CSF-Aβ, Tau, phospho-Tau, neurogranin, synaptotagmin, synaptosomal-associated protein-25 (SNAP25), neurofilament light chain (NfL), and Aβ-oligomers.Change from baseline is calculated as the observed value minus the baseline value.
Measured: Baseline to Day 182
Amyloid Beta 1-42/Amyloid Beta 1-40 (Aβ42/40) in the Cerebrospinal Fluid (CSF) Biomarkers
Ratio of Amyloid Beta 1-42 (Aβ42) to Amyloid Beta 1-40 (Aβ40) Concentration from Baseline to Day 182.
Measured: Baseline to Day 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start10 Oct 2018
- Primary completion29 May 2024
- Study completion29 May 2024
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate Alzheimer's 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-center Phase 2, randomized, double-blind, placebo-controlled, parallel-group study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cognition Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Anthony Caggiano, MD, Study director, Cognition Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507790
- Sponsor's protocol ID
- COG0201
- Other IDs
- R01AG058660, 2022-002326-27
- Status last verified
- Aug 2025
- First submitted
- 10 Apr 2018
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Caro V, Cho E, Thiel J, Lizama BN, Koel-Simmelink MJA, Pandey K, Duong D, Seyfried NT, Grundman M, Teunissen CE, Zetterberg H, Blennow K, Caggiano AO, Hamby ME. Impact of zervimesine on the neuroinflammatory biomarker GFAP and related proteomic molecular correlates in plasma of participants from a phase 2 clinical trial in Alzheimer's disease. Alzheimers Res Ther. 2026 Apr 6;18(1):112. doi: 10.1186/s13195-026-02025-4.
PubMed 41943055Vijverberg EGB, Scharre DW, Woodward M, Catalano S, Hamby ME, Grundman M, Morgan RE, Iaci J, Devins T, Caggiano AO. Randomized, double-blind study of zervimesine in mild to moderate Alzheimer's disease. J Alzheimers Dis. 2026 May;111(2):897-908. doi: 10.1177/13872877261437145. Epub 2026 Apr 3.
PubMed 41930592Lizama BN, Williams C, North HA, Pandey K, Duong D, Di Caro V, Mecca AP, Blennow K, Zetterberg H, Levey AI, Grundman M, van Dyck CH, Caggiano AO, Seyfried NT, Hamby ME. CT1812 biomarker signature from a meta-analysis of CSF proteomic findings from two Phase 2 clinical trials in Alzheimer's disease. Alzheimers Dement. 2024 Oct;20(10):6860-6880. doi: 10.1002/alz.14152. Epub 2024 Aug 21.
PubMed 39166791Lizama BN, North HA, Pandey K, Williams C, Duong D, Cho E, Di Caro V, Ping L, Blennow K, Zetterberg H, Lah J, Levey AI, Grundman M, Caggiano AO, Seyfried NT, Hamby ME. An interim exploratory proteomics biomarker analysis of a phase 2 clinical trial to assess the impact of CT1812 in Alzheimer's disease. Neurobiol Dis. 2024 Sep;199:106575. doi: 10.1016/j.nbd.2024.106575. Epub 2024 Jun 22.
PubMed 38914170
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT03507790
- Acronym / sponsor ID
- COG0201
- Conditions
- Mild to Moderate Alzheimer's Disease
- Keywords
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Cognition TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Posted 11 Aug 2025
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 multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).
This Phase 2 study is designed to evaluate the safety of two doses of CT1812 administered once daily for 6 months in adults aged 50 to 85 who have been diagnosed with mild to moderate Alzheimer's disease. Randomized participants will receive 100 mg of CT1812, 300 mg of CT1812, or placebo once daily for 182 days. Exploratory endpoints that evaluate the effect of CT1812 on biomarkers are also included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a multi-center Phase 2, randomized, double-blind, placebo-controlled, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment- CT1812 100 mg | Active comparator | Drug: CT1812CT1812 at a dose of 100 mg |
| Active Treatment- CT1812 300 mg | Active comparator | Drug: CT1812CT1812 at a dose of 300mg |
| Placebo Comparator - Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.
- Diagnostic confirmation by amyloid PET with florbetaben or another approved amyloid PET ligand. Previous amyloid imaging study with a positive result will be accepted. If none is available, then amyloid PET will be conducted during screening. Diagnostic confirmation by a CSF sample collected at the screening visit lumbar puncture in place of amyloid PET will also be acceptable
- Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease and without findings of significant exclusionary abnormalities (see exclusion criteria, number 4). An historical MRI, up to 1 year prior to screening, may be used as long as there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs suggestive of such intervening events.).
- MMSE 18-26 inclusive.
Key exclusion criteria (8 listed)
- Screening MRI (or historical MRI, if applicable) of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct >1 cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility..
- Clinical or laboratory findings consistent with:
- A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder. Subjects with depressive symptoms successfully managed by a stable dose of an antidepressant are allowed entry.
- Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.
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 |
|---|---|---|
| CT1812Also: Study Drug, zervimesineActive Study Drug | Drug | Active Treatment- CT1812 100 mg, Active Treatment- CT1812 300 mg |
| PlaceboAlso: Matching PlaceboNon-active study drug | Drug | Placebo Comparator - Placebo |
Primary outcome
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 210 Days
Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).
Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs).
Time frame: Up to 210 Days
Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).
2 secondary outcomes
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers
Time frame: Baseline to Day 182
Amyloid Beta 1-42/Amyloid Beta 1-40 (Aβ42/40) in the Cerebrospinal Fluid (CSF) Biomarkers
Time frame: Baseline to Day 182
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41943055Di Caro V, Cho E, Thiel J, Lizama BN, Koel-Simmelink MJA, Pandey K, Duong D, Seyfried NT, Grundman M, Teunissen CE, Zetterberg H, Blennow K, Caggiano AO, Hamby ME. Impact of zervimesine on the neuroinflammatory biomarker GFAP and related proteomic molecular correlates in plasma of participants from a phase 2 clinical trial in Alzheimer's disease. Alzheimers Res Ther. 2026 Apr 6;18(1):112. doi: 10.1186/s13195-026-02025-4.
- Derived from this study: PubMed 41930592Vijverberg EGB, Scharre DW, Woodward M, Catalano S, Hamby ME, Grundman M, Morgan RE, Iaci J, Devins T, Caggiano AO. Randomized, double-blind study of zervimesine in mild to moderate Alzheimer's disease. J Alzheimers Dis. 2026 May;111(2):897-908. doi: 10.1177/13872877261437145. Epub 2026 Apr 3.
- Derived from this study: PubMed 39166791Lizama BN, Williams C, North HA, Pandey K, Duong D, Di Caro V, Mecca AP, Blennow K, Zetterberg H, Levey AI, Grundman M, van Dyck CH, Caggiano AO, Seyfried NT, Hamby ME. CT1812 biomarker signature from a meta-analysis of CSF proteomic findings from two Phase 2 clinical trials in Alzheimer's disease. Alzheimers Dement. 2024 Oct;20(10):6860-6880. doi: 10.1002/alz.14152. Epub 2024 Aug 21.
- Derived from this study: PubMed 38914170Lizama BN, North HA, Pandey K, Williams C, Duong D, Cho E, Di Caro V, Ping L, Blennow K, Zetterberg H, Lah J, Levey AI, Grundman M, Caggiano AO, Seyfried NT, Hamby ME. An interim exploratory proteomics biomarker analysis of a phase 2 clinical trial to assess the impact of CT1812 in Alzheimer's disease. Neurobiol Dis. 2024 Sep;199:106575. doi: 10.1016/j.nbd.2024.106575. Epub 2024 Jun 22.
- Shine Study InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mild to Moderate Alzheimer's Disease
Not yet recruiting
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
Memory Disorders, Mild Cognitive Impairment
Not yet recruitingPhase 3
Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study
Alzheimer Disease
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
Alzheimer's Disease
Active, not recruitingPhase 2/3
Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease
Dementia Moderate, Dementia, Mild
RecruitingPhase 4
A Study of Zunveyl on Safety, Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Alzheimer's Disease (RESOLVE)
Alzheimer Disease
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.
Anthony Caggiano, MD study director
Cognition Therapeutics
32 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT1812 in people with Mild to Moderate Alzheimer's Disease, run by Cognition Therapeutics at 32 sites in 5 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 6 inclusion and 8 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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Czechia, Spain, Australia, Netherlands. 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 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.
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 11 Aug 2025). 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?
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 210 Days). 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?
On the ClinicalTrials.gov record for NCT03507790, which also lists 4 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 11 Aug 2025.