Kidney Transplant; ComplicationsNCT04042272
Evaluation of s100β, NSE and GFAP Levels in Renal Transplantation
An observational study of Kidney Transplant; Complications and Neurologic Manifestations, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Uremic encephalopathy is an organic brain disorder may be frequently seen in patients with acute or chronic renal failure. Certain neurological symptoms can be found under clinical glomerular filtration rate of 15 ml/minutes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplant; Complications, Neurologic Manifestations, Uremic Encephalopathy
- What is being tested?
- S100β, Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP)
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2019to 15 Jan 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients' demographic data (age, gender, weight, height), accompanying diseases, ASA classification, main etiology, preoperative serums taken in the preoperative period; serum sodium, potassium, ammonium, total bilirubin, ALT, AST, albumin, alkaline phosphatase, INR, creatinine, and BUN shall be recorded accordingly. In addition, routinely taken anesthetics, duration of the operation, duration of anesthesia, duration before the reperfusion, duration of postperfusion, graft hot and cold ischemia durations, first measured central venous pressure, volume replacement therapy, blood component transfusion, total fluid amount given during the operation, corticosteroids and immunosuppressive drugs given during the operation shall be recorded.
Who may be able to join
- End-stage renal failure patients
- Healthy volunteer patients.
Who cannot join
- Nonvolunteers
- Active infections
- Oncologic or hematologic diseases
- Cadaver graft recipients
- History with psychoactive medications
- History with a respiratory system or central nervous system disorders
- Severe heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of s100β, NSE and Glial Fibrillary Acidic Protein Levels in Preoperative and Postoperative Renal Transplantation
Uremic encephalopathy is an organic brain disorder may be frequently seen in patients with acute or chronic renal failure. Certain neurological symptoms can be found under clinical glomerular filtration rate of 15 ml/minutes. The above mentioned neurological disorders can be due to uremic toxins as well as many other reasons such as metabolic and hemodynamic disturbances, inflammation, or oxidative stress. Most frequent symptoms are impaired consciousness, lethargy, cranial nerve involvement, nystagmus, dysarthria, and even coma and death. Brain tissue may receive damage and some secondary biomarkers may appear in case BUN (Blood Urea Nitrogen) level is >175 mg/dl together with neuroinflammation. Although hemodialysis is a temporary solution in terms of treatment, these symptoms may be reversible in the long-run with organ transplantation. A rigorous neurological assessment before transplantation is important for identifying the severity and distribution of the neurological disorder as well as defining the abnormalities that are responding to the current treatments and foreseeing potential postoperative prognosis.
S100β is excreted by astrocytes in brain damage cases. S100β level rises when brain damage starts, thus it may be used in the prognosis of brain damage in its early period. Neuron-specific enolase (NSE) functions as intracytoplasmic enzyme and serum level rises in neuron damage. Glial fibrillary acidic protein (GFAP), on the other hand, is the intermediary filament cytoskeleton protein found in astrocytes. It has the same root structure with S100β.
The purpose of this study is to assess neurological damage by looking at the levels of S100β, NSE and GFAP in patients who underwent kidney transplantation and to analyze the impacts on the prognosis.
Read the detailed description
Encephalopathy, thiamine deficiency, uremia, hypertension, electrolyte imbalance after dialysis are clinical pictures with high incidences in case of renal failure. There are multifactor reasons in its pathophysiology such as hormonal imbalance, oxidative stress, accumulation of metabolites in time, disorders in excitatory and inhibitory transmitters and intermediary metabolisms.
Neurological disorders that affect renal transplant patients during the waiting list period do not only significantly affect preoperative morbidity and even mortality, but also show important predictive factors for neurological symptoms after the transplantation. A rigorous neurological assessment before transplantation is important for identifying the severity and distribution of the neurological disorder as well as defining the abnormalities that are responding to the current treatments and foreseeing potential postoperative prognosis. Specific indexes preferred for neurological assessment before the transplant may vary depending on the clinic; however, correct and differential diagnosis of various symptoms may be difficult despite the use of various diagnostic tools such as biochemical, neurophysiologic, neuropsychological and neuroimaging tools.
S100β is a 10.4 kDa protein. S100β is synthesized in the brain through endfeet processes of astrocytes and it belongs to the superfamily of low molecular weight EF-hand type acidic calcium-binding proteins. This protein is metabolized in the kidneys first and foremost and then discharged through urine. It has been shown that S100β does not differ depending on ethnic groups and genders and is not affected by circadian rhythm. Even though S100β may be found in other tissues, it may be used as an early marker for brain damage since it is found in higher concentration in the brain.
Astrocytes are the key agents for homeostasis regulation in the central nervous system (CNS) and they secrete S100β after brain damage. Certain studies show that increased levels of S100β may be used as an early marker of intracerebral changes in the brains of patients with acute or chronic liver failure and hepatic encephalopathy (HE) before the development of cerebral edema.
Moreover, some studies suggest that increased levels of S100β in serum concentrations may predict HE. However, there are few pieces of evidence that prove the correlation between S100β levels and HE's presence.
NSE (neuron-specific enolase) is a CNS protein found in neurons and neuroendocrine tissues. NSE functions in the glycolytic path of neurons as an intracytoplasmic enzyme and its serum levels increase in case of neuron damage. S100β is a marker of astroglial dysfunction while NSE is a marker of neuronal dysfunction.
And Glial fibrillary acidic protein (GFAP) is reported to be more specific to brain tissue compared to S100β. There are studies showing that prognosis is worse when both GFAP and S100β levels are seen to increase in the assessment of neurological damage, especially in cases of head traumas, thus supporting the use of both proteins for higher prognostic accuracy. GFAP is also a biomarker used for neurodegenerative diseases and ischemic cases other than cases of trauma.
The aim of the present study is to analyze neurological damage in renal transplant patients through S100β, NSE and GFAP serum concentrations and assess their impacts on the prognosis.
- Being tested
- S100β, Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP)
- Keywords
- kidney transplantation, s100β, neuron specific enolase, glial fibrillary acidic protein
- Medical subject headings
- Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S100β, Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP)Diagnostic test
S100β is 10.4 kDa protein. Synthesized with end-feet processes of astrocytes in the brain S100β belongs to low molecular weight EF-hand type acidic calcium-binding protein superfamily. This protein is metabolized in the kidneys and removed with urine. It is shown that S100β does not show differences due to ethnical groups or genders and is not affected by circadian rhythm. Although S100β is also found in other tissues, it is in higher concentrations in the brain so it can be used as an early indicator for brain damage.NSE is an SSS protein which exists in neurons and neuroendocrine tissues. NSE plays a role in glycolytic route in neurons as intracytoplasmic enzyme increasing serum level in case of neuron damage. Whilst S100β is the marker of astroglia dysfunction, NSE is the marker of neuronal dysfunction. Glial fibrillary acidic protein (GFAP) is the intermediate filament cell skeleton protein found in astrocytes. It originates from the same root structure as S100β.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volunteers group; Kidney donor groups; Course of the research: Blood samples from all groups shall be taken for S100β, NSE, and GFAP in the preoperative period, in the operating room and after 1st, 7th day and the first following month in the postoperative period. Mortality and morbidity of the patients shall be recorded. Neurological damage and its effect on prognosis shall be examined within the patients with S100β, NSE, and GFAP. Patients' demographic data, accompanying diseases, American Society of Anesthesiology classification, main etiology, preoperative laboratory values shall be recorded accordingly. In addition, routinely taken anesthetics, duration of the operation, duration of anesthesia, duration before the reperfusion, duration of postperfusion, graft hot and cold ischemia durations, first measured central venous pressure, volume replacement therapy, blood component transfusion, and immunosuppressive drugs are given during the operation shall be recorded. Receives: Diagnostic Test: S100β, Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP) | |
| Living kidney graft recipients | Kidney transplant group; Course of the research: Course of the research: Blood samples from all groups shall be taken for S100β, NSE, and GFAP in the preoperative period, in the operating room and after 1st, 7th day and the first following month in the postoperative period. Mortality and morbidity of the patients shall be recorded. Neurological damage and its effect on prognosis shall be examined within the patients with S100β, NSE, and GFAP. Patients' demographic data, accompanying diseases, American Society of Anesthesiology classification, main etiology, preoperative laboratory values shall be recorded accordingly. In addition, routinely taken anesthetics, duration of the operation, duration of anesthesia, duration before the reperfusion, duration of postperfusion, graft hot and cold ischemia durations, first measured central venous pressure, volume replacement therapy, blood component transfusion, and immunosuppressive drugs are given during the operation shall be recorded. Receives: Diagnostic Test: S100β, Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of serum s100β
Approximately 40 patients planned to have living donor renal transplantation and 40 patients planned to have nephrectomy for kidney donation will be included in the study.
The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the seventh day and the first month) period to analyze S100β serum concentrations and neurologic damage of kidney transplantation and nephrectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until plasma separation process.
Measured: 2 years
Assessment of serum NSE
Approximately 40 patients planned to have living donor renal transplantation and 40 patients planned to have nephrectomy for kidney donation will be included in the study.
The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the seventh day and the first month) period to analyze NSE serum concentrations and neurologic damage of kidney transplantation and nephrectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until plasma separation process.
Measured: 2 years
Assessment of serum GFAP
Approximately 40 patients planned to have living donor renal transplantation and 40 patients planned to have nephrectomy for kidney donation will be included in the study.
The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the seventh day and the first month) period to analyze GFAP serum concentrations and neurologic damage of kidney transplantation and nephrectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until plasma separation process.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start15 Aug 2019
- Primary completion15 Dec 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bora Dinc, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042272
- Sponsor's protocol ID
- S100β, NSE n GFAP in RT
- Status last verified
- Apr 2021
- First submitted
- 31 Jul 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of s100β, NSE and Glial Fibrillary Acidic Protein Levels in Preoperative and Postoperative Renal Transplantation
- ClinicalTrials.gov ID
- NCT04042272
- Acronym / sponsor ID
- S100β, NSE n GFAP in RT
- Keywords
- kidney transplantation, s100β, neuron specific enolase, glial fibrillary acidic protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 1 Aug 2019 (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.
Uremic encephalopathy is an organic brain disorder may be frequently seen in patients with acute or chronic renal failure. Certain neurological symptoms can be found under clinical glomerular filtration rate of 15 ml/minutes. The above mentioned neurological disorders can be due to uremic toxins as well as many other reasons such as metabolic and hemodynamic disturbances, inflammation, or oxidative stress. Most frequent symptoms are impaired consciousness, lethargy, cranial nerve involvement, nystagmus, dysarthria, and even coma and death. Brain tissue may receive damage and some secondary biomarkers may appear in case BUN (Blood Urea Nitrogen) level is >175 mg/dl together with neuroinflammation. Although hemodialysis is a temporary solution in terms of treatment, these symptoms may be reversible in the long-run with organ transplantation. A rigorous neurological assessment before transplantation is important for identifying the severity and distribution of the neurological disorder as well as defining the abnormalities that are responding to the current treatments and foreseeing potential postoperative prognosis.
S100β is excreted by astrocytes in brain damage cases. S100β level rises when brain damage starts, thus it may be used in the prognosis of brain damage in its early period. Neuron-specific enolase (NSE) functions as intracytoplasmic enzyme and serum level rises in neuron damage. Glial fibrillary acidic protein (GFAP), on the other hand, is the intermediary filament cytoskeleton protein found in astrocytes. It has the same root structure with S100β.
The purpose of this study is to assess neurological damage by looking at the levels of S100β, NSE and GFAP in patients who underwent kidney transplantation and to analyze the impacts on the prognosis.
Detailed description
Encephalopathy, thiamine deficiency, uremia, hypertension, electrolyte imbalance after dialysis are clinical pictures with high incidences in case of renal failure. There are multifactor reasons in its pathophysiology such as hormonal imbalance, oxidative stress, accumulation of metabolites in time, disorders in excitatory and inhibitory transmitters and intermediary metabolisms.
Neurological disorders that affect renal transplant patients during the waiting list period do not only significantly affect preoperative morbidity and even mortality, but also show important predictive factors for neurological symptoms after the transplantation. A rigorous neurological assessment before transplantation is important for identifying the severity and distribution of the neurological disorder as well as defining the abnormalities that are responding to the current treatments and foreseeing potential postoperative prognosis. Specific indexes preferred for neurological assessment before the transplant may vary depending on the clinic; however, correct and differential diagnosis of various symptoms may be difficult despite the use of various diagnostic tools such as biochemical, neurophysiologic, neuropsychological and neuroimaging tools.
S100β is a 10.4 kDa protein. S100β is synthesized in the brain through endfeet processes of astrocytes and it belongs to the superfamily of low molecular weight EF-hand type acidic calcium-binding proteins. This protein is metabolized in the kidneys first and foremost and then discharged through urine. It has been shown that S100β does not differ depending on ethnic groups and genders and is not affected by circadian rhythm. Even though S100β may be found in other tissues, it may be used as an early marker for brain damage since it is found in higher concentration in the brain.
Astrocytes are the key agents for homeostasis regulation in the central nervous system (CNS) and they secrete S100β after brain damage. Certain studies show that increased levels of S100β may be used as an early marker of intracerebral changes in the brains of patients with acute or chronic liver failure and hepatic encephalopathy (HE) before the development of cerebral edema.
Moreover, some studies suggest that increased levels of S100β in serum concentrations may predict HE. However, there are few pieces of evidence that prove the correlation between S100β levels and HE's presence.
NSE (neuron-specific enolase) is a CNS protein found in neurons and neuroendocrine tissues. NSE functions in the glycolytic path of neurons as an intracytoplasmic enzyme and its serum levels increase in case of neuron damage. S100β is a marker of astroglial dysfunction while NSE is a marker of neuronal dysfunction.
And Glial fibrillary acidic protein (GFAP) is reported to be more specific to brain tissue compared to S100β. There are studies showing that prognosis is worse when both GFAP and S100β levels are seen to increase in the assessment of neurological damage, especially in cases of head traumas, thus supporting the use of both proteins for higher prognostic accuracy. GFAP is also a biomarker used for neurodegenerative diseases and ischemic cases other than cases of trauma.
The aim of the present study is to analyze neurological damage in renal transplant patients through S100β, NSE and GFAP serum concentrations and assess their impacts on the prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Diagnostic Test: S100β, Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP)Healthy volunteers group; Kidney donor groups; Course of the research: Blood samples from all groups shall be taken for S100β, NSE, and GFAP in the preoperative period, in the operating room and after 1st, 7th day and the first following month in the postoperative period. Mortality and morbidity of the patients shall be recorded. Neurological damage and its effect on prognosis shall be examined within the patients with S100β, NSE, and GFAP. Patients' demographic data, accompanying diseases, American Society of Anesthesiology classification, main etiology, preoperative laboratory values shall be recorded accordingly. In addition, routinely taken anesthetics, duration of the operation, duration of anesthesia, duration before the reperfusion, duration of postperfusion, graft hot and cold ischemia durations, first measured central venous pressure, volume replacement therapy, blood component transfusion, and immunosuppressive drugs are given during the operation shall be recorded. |
| Living kidney graft recipients | – | Diagnostic Test: S100β, Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP)Kidney transplant group; Course of the research: Course of the research: Blood samples from all groups shall be taken for S100β, NSE, and GFAP in the preoperative period, in the operating room and after 1st, 7th day and the first following month in the postoperative period. Mortality and morbidity of the patients shall be recorded. Neurological damage and its effect on prognosis shall be examined within the patients with S100β, NSE, and GFAP. Patients' demographic data, accompanying diseases, American Society of Anesthesiology classification, main etiology, preoperative laboratory values shall be recorded accordingly. In addition, routinely taken anesthetics, duration of the operation, duration of anesthesia, duration before the reperfusion, duration of postperfusion, graft hot and cold ischemia durations, first measured central venous pressure, volume replacement therapy, blood component transfusion, and immunosuppressive drugs are given during the operation shall be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients' demographic data (age, gender, weight, height), accompanying diseases, ASA classification, main etiology, preoperative serums taken in the preoperative period; serum sodium, potassium, ammonium, total bilirubin, ALT, AST, albumin, alkaline phosphatase, INR, creatinine, and BUN shall be recorded accordingly. In addition, routinely taken anesthetics, duration of the operation, duration of anesthesia, duration before the reperfusion, duration of postperfusion, graft hot and cold ischemia durations, first measured central venous pressure, volume replacement therapy, blood component transfusion, total fluid amount given during the operation, corticosteroids and immunosuppressive drugs given during the operation shall be recorded.
Key inclusion criteria (2 listed)
- End-stage renal failure patients
- Healthy volunteer patients.
Key exclusion criteria (7 listed)
- Nonvolunteers
- Active infections
- Oncologic or hematologic diseases
- Cadaver graft recipients
- History with psychoactive medications
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 |
|---|---|---|
| S100β, Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP)S100β is 10.4 kDa protein. Synthesized with end-feet processes of astrocytes in the brain S100β belongs to low molecular weight EF-hand type acidic calcium-binding protein superfamily. This protein is metabolized in the kidneys and removed with urine. It is shown that S100β does not show differences due to ethnical groups or genders and is not affected by circadian rhythm. Although S100β is also found in other tissues, it is in higher concentrations in the brain so it can be used as an early indicator for brain damage.NSE is an SSS protein which exists in neurons and neuroendocrine tissues. NSE plays a role in glycolytic route in neurons as intracytoplasmic enzyme increasing serum level in case of neuron damage. Whilst S100β is the marker of astroglia dysfunction, NSE is the marker of neuronal dysfunction. Glial fibrillary acidic protein (GFAP) is the intermediate filament cell skeleton protein found in astrocytes. It originates from the same root structure as S100β. | Diagnostic test | Healthy volunteers, Living kidney graft recipients |
Primary outcome
Assessment of serum s100β
Time frame: 2 years
Approximately 40 patients planned to have living donor renal transplantation and 40 patients planned to have nephrectomy for kidney donation will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the seventh day and the first month) period to analyze S100β serum concentrations and neurologic damage of kidney transplantation and nephrectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until plasma separation process.
Assessment of serum NSE
Time frame: 2 years
Approximately 40 patients planned to have living donor renal transplantation and 40 patients planned to have nephrectomy for kidney donation will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the seventh day and the first month) period to analyze NSE serum concentrations and neurologic damage of kidney transplantation and nephrectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until plasma separation process.
Assessment of serum GFAP
Time frame: 2 years
Approximately 40 patients planned to have living donor renal transplantation and 40 patients planned to have nephrectomy for kidney donation will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the seventh day and the first month) period to analyze GFAP serum concentrations and neurologic damage of kidney transplantation and nephrectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until plasma separation process.
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 28 Apr 2021.
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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?
An observational study of Kidney Transplant; Complications and Neurologic Manifestations, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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 28 Apr 2021. 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 Turkey (Türkiye). 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?
Assessment of serum s100β (time frame: 2 years). The study lists 3 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 28 Apr 2021.