Maringa

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

Researchers are studying the use of bempedoic acid alone or combined with ezetimibe in adult patients who have primary hypercholesterolemia both heterozygous familial and non-familial types or mixed dyslipidemia. This observational study aims to collect real-world data from Asian and Latin American patients to better understand the risks and benefits of these treatments, as current efficacy and safety information in these populations is limited. Participants in this study receive routine clinical care where they may be treated with bempedoic acid alone or its fixed-dose combination with ezetimibe. No experimental drugs are administered as this is a non-interventional study. The study follows patients for one year after starting the treatment to observe outcomes in their usual care setting. Throughout the one-year follow-up, researchers collect data on patient characteristics, adverse drug reactions, and adverse events related to the treatments. They also assess cardiovascular risk, cholesterol levels including LDL-C, inflammatory markers, uric acid levels, and the attainment of cholesterol goals. This information is gathered from medical records and routine clinical assessments to monitor the safety and effects of the treatments over time.

Researchers are evaluating the safety and effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

Researchers are evaluating the effectiveness and safety of brenipatide combined with standard care compared to a placebo plus standard care for treating schizophrenia in adults aged 18 to 55. This phase 2 clinical trial aims to better understand how brenipatide works alongside existing treatments in this population. Participants are randomly assigned to receive either brenipatide or placebo, both administered by subcutaneous injection, alongside their usual standard of care medications. The study includes a screening period lasting about one month, followed by a treatment period that can last up to 12 months, and then a follow-up period of approximately two months. During the trial, participants will attend scheduled visits to monitor their health, complete questionnaires, and maintain diaries about their medication use. Researchers will measure changes in body weight, neurocognitive function, schizophrenia symptom severity, and other clinical assessments. Safety is closely monitored throughout, and the total participation time may last up to about 15 months.

Researchers are evaluating the efficacy and safety of a combination of KarXT and KarX-EC to treat cognitive impairment in individuals with mild to moderate Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to understand how these treatments affect thinking and memory problems associated with Alzheimers. The study is sponsored by Bristol-Myers Squibb and focuses on participants aged 60 to 85 years diagnosed according to specific clinical criteria and biomarkers. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. The medications are given at specified doses on designated days, though exact dosing schedules are not detailed in the summary. The study follows a parallel-group design, comparing the effects of the active drugs against placebo over a treatment period lasting 24 weeks. During the study, participants and their caregivers will attend visits where cognitive function and daily living abilities are assessed using tools such as the Alzheimers Disease Assessment Scale-Cognitive Subscale ADAS-Cog11 and Clinicians Interview-Based Impression Plus Caregiver Input CIBIC. Safety is closely monitored through reports of adverse events, vital signs, laboratory tests, ECGs, and other clinical evaluations. The study lasts through the treatment period up to 24 weeks, with continuous monitoring of participant health and cognitive changes.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Healthcare-associated infections HAIs are a significant issue in intensive care units ICUs, often caused by environmental contamination with multidrug-resistant organisms that remain despite regular cleaning. Researchers are evaluating two advanced disinfection methodshydrogen peroxide aerosolization and ultraviolet-C lightto reduce this contamination. This cluster-randomized, crossover trial will be conducted in 12 Brazilian ICUs to compare these methods with usual surface disinfection practices. The trial includes three sequential cleaning strategies for each ICU usual surface disinfection alone usual disinfection followed by hydrogen peroxide aerosolization at 7.9% concentration applied inside a protective tent during terminal cleaning of beds and usual disinfection followed by automated ultraviolet-C irradiation applied under the same tent. The protective tent is used to prevent exposure of adjacent beds and ICU areas to the disinfecting agents. Participants will be all patients aged 18 years and older admitted to these ICUs. Researchers will measure antimicrobial use at the ICU level over three months, daily defined doses per 100 patient-days, and secondary outcomes such as rates of HAIs, contamination by multidrug-resistant organisms, specific infections like ventilator-associated pneumonia, bloodstream infections, urinary tract infections, and ICU length of stay costs. Safety and effectiveness of surface disinfection methods will be monitored throughout the study.

This research aims to evaluate whether an educational quality improvement intervention focused on antimicrobial stewardship can reduce antimicrobial use in adult patients admitted to intensive care units ICUs in Brazil. The study compares current ICU practices with those after implementing the intervention, which is based on up-to-date guidelines and aims to promote rational antimicrobial use without increasing ICU mortality or length of stay. The trial uses a stepped-wedge cluster randomized design across 10 ICUs participating in the IMPACTO-MR registry platform. The intervention includes educational sessions, cognitive aids for ICU physicians and healthcare professionals to improve decisions on antimicrobial initiation and duration, and monthly audits with feedback to the ICU teams. Each ICU starts with a control phase of usual care, then transitions to the intervention phase approximately monthly starting July 2025. The study also includes a baseline data collection period before the intervention and a phase-out period to assess lasting effects after stopping feedback. Participants are all adult patients admitted to the participating ICUs during the study. Researchers will collect monthly one-day point-prevalence surveys on antimicrobial use and monitor ICU mortality rates and length of stay over 14 months to evaluate outcomes. The study will assess the impact of the educational intervention on antimicrobial use while ensuring patient safety, with no individual informed consent required due to cluster-level data collection and minimal risk.

This research aims to identify individuals who may be eligible for interventional studies related to Alzheimers Disease by assessing specific biomarkers and cognitive performance. It is a Phase 3 screening study sponsored by Hoffmann-La Roche designed to evaluate potential participants using blood tests and cognitive assessments. The study focuses on adults aged 50 to 90 years to find candidates for further Alzheimers disease research. Participants will not receive any treatment but will undergo blood draws to measure the concentration of the biomarker pTau217. They will also complete the International Shopping List Test ISLT to assess cognitive function. This screening process helps determine eligibility for linked interventional Alzheimers disease studies by combining biomarker and cognitive data. During the study, participants will provide blood samples and perform cognitive tests at the initial visit. Researchers will measure the pTau217 levels in blood and record cognitive scores from the ISLT. The study involves no experimental treatment, focusing solely on assessment. Participation lasts until the primary completion date, with data collected on Day 1 to evaluate potential eligibility for further trials.