Maringa

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Researchers are evaluating the safety and effectiveness of brenipatide combined with standard care compared to a placebo with standard care in adults with schizophrenia. This phase 2 study aims to understand how well brenipatide works as an additional treatment for schizophrenia and monitor any side effects. Participants eligible for the study must have schizophrenia and be on stable standard care medication. The trial consists of three main periods: a screening period lasting about one month, a treatment period that can last up to 12 months, and a follow-up period of approximately two months. During the treatment phase, participants receive either brenipatide or placebo administered by subcutaneous injection alongside their standard care. The study includes careful monitoring and adherence to study procedures such as self-injection, keeping diaries, and completing questionnaires. Participants will be involved in regular visits and assessments throughout the entire study duration, which may last up to 15 months. Researchers will measure changes in body weight from baseline to week 52 as a primary outcome. Participants will also be monitored for safety and efficacy through ongoing evaluations, including the use of electronic or paper diaries and required questionnaires to track their progress and response to treatment.

Researchers are evaluating the effectiveness and safety of KarXT combined with KarX-EC for treating cognitive impairment in people with mild to moderate Alzheimer's Disease. This Phase 3 study focuses on individuals aged 60 to 85 who have a confirmed diagnosis of Alzheimer's disease according to updated clinical criteria and have specific cognitive scores indicating mild to moderate dementia. Participants will receive either the study drugs KarXT and KarX-EC or a placebo, each given at specified doses on certain days. The study is randomized, double-blind, and placebo-controlled to compare the effects of these treatments on cognitive function. Those already taking certain Alzheimer's medications must have stable doses before and during the study. During the study, participants and their caregivers will attend multiple visits where cognitive assessments and interviews will be performed. Key measures include changes in a cognitive scale (ADAS-Cog11) and clinical impressions of improvement at 24 weeks. Caregivers play an important role by providing information, ensuring medication adherence, and participating in study activities. Safety and treatment effects will be carefully monitored throughout the trial.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Healthcare-associated infections (HAIs) are a major issue in intensive care units (ICUs), often caused by contamination with multidrug-resistant organisms that remain despite routine cleaning. This trial evaluates different surface disinfection methods to reduce such contamination and improve patient outcomes. It is a cluster-randomized, crossover study conducted in 12 Brazilian ICUs, comparing usual cleaning methods with additional disinfection technologies. The trial involves three sequential strategies in each ICU: usual surface disinfection alone; usual disinfection followed by aerosolized hydrogen peroxide sprayed at 7.9% concentration inside a protective tent during terminal cleaning of patient beds; and usual disinfection followed by automated ultraviolet-C light irradiation applied under the same protective tent to disinfect beds and nearby surfaces. These methods are compared to assess their impact on infection control. Participants admitted to the ICUs will be monitored for antimicrobial use, which is the primary outcome measured as daily defined doses per 100 patient-days over three months. Secondary outcomes include rates of HAIs, environmental contamination by resistant organisms, specific infection types like ventilator-associated pneumonia, bloodstream infections, urinary tract infections, and ICU length of stay and costs. The study includes assessments of contamination and infection rates during each intervention period to evaluate effectiveness and safety.

Researchers are investigating whether an educational quality improvement intervention can reduce the use of antimicrobials in adult patients admitted to intensive care units (ICUs) in Brazil. This trial focuses on critically ill patients and aims to see if training ICU doctors and healthcare professionals to follow updated guidelines can decrease antimicrobial consumption without negatively impacting ICU mortality rates or length of stay. The study is designed as a stepped-wedge cluster randomized trial involving 10 ICUs participating in a larger registry focused on ICU infections and antimicrobial use. The intervention includes educational sessions, an operations manual, and cognitive aids to help ICU physicians make better decisions about starting, reviewing, and stopping antimicrobials based on current recommendations. Each ICU will receive an initial site visit to deliver training and assess local barriers to implementation. Following this, monthly one-day audits will be performed to monitor antimicrobial use and provide feedback to the ICU teams. The study includes a baseline period before the intervention, a phased implementation over 10 steps starting in July 2025, and a three-month phase-out period to observe if benefits persist after active feedback stops. Participants will be adult patients admitted to the ICUs during the study period. Data collection includes monthly point-prevalence surveys of antimicrobial use and routine information from the existing ICU registry. Researchers will evaluate antimicrobial utilization at the ICU level over 14 months, monitoring safety outcomes such as ICU mortality and length of stay. The total participation for each ICU spans from baseline through intervention and phase-out periods, with ongoing data analysis to assess the intervention's impact.

This study is designed to identify individuals who may be eligible for future Roche clinical trials focused on Alzheimer's disease. It serves as a pre-screening step to evaluate participants based on biomarker status and cognitive performance. The study targets adults aged 50 to 90 years who have experienced memory concerns recently, with or without a diagnosis of mild cognitive impairment or dementia due to Alzheimer's disease. Participants do not receive any intervention during this study. Instead, they will have their blood drawn to measure the concentration of a biomarker called pTau217 and will undergo a cognitive assessment using the ISLT (International Shopping List Test) on the first day of participation. This process helps researchers determine potential eligibility for more extensive Alzheimer's disease trials. During the study, participants will be evaluated for memory concerns and cognitive function through blood tests and cognitive scoring. Researchers will monitor biomarker levels and cognitive scores on the first day to help assess trial eligibility. The study includes safety assessments to ensure participants can safely complete these procedures, with participation lasting for the duration of the pre-screening evaluations.

Researchers are evaluating whether patients with ventilator-associated tracheobronchitis (VAT) in intensive care units benefit from a 7-day course of antibiotics compared to clinical observation without antibiotic treatment. This trial is a national, multicenter, single-blinded, randomized non-inferiority study aiming to determine if monitoring without antibiotics is as effective as antibiotic therapy for VAT, given the current uncertainty and conflicting guidelines about antibiotic use for this condition. Participants diagnosed with VAT will be randomly assigned to one of two groups. One group will receive standard care plus a 7-day antibiotic course, while the other group will have clinical observation without antibiotics unless they develop new organ dysfunction or infections other than VAT. The study focuses on comparing these two approaches to see if withholding antibiotics is noninferior in managing VAT. During the study, patients will be monitored for ventilator-free days within 28 days after randomization. Researchers will assess clinical status, chest imaging, and tracheal secretion cultures. Safety and treatment effects will be carefully tracked, with data analysis conducted in a blinded manner. The trial encompasses ICU patients who have been mechanically ventilated for at least 48 hours and meet specific clinical and laboratory criteria for VAT.