Albacete

Researchers are evaluating the use of sodium zirconium cyclosilicate SZC to help optimize renin-angiotensin aldosterone system inhibitor RAASi therapies in elderly patients aged 70 and older who have heart failure and chronic kidney disease. Many patients with these conditions do not receive recommended RAASi doses because of elevated potassium levels, which can be dangerous. This study aims to see if adding SZC allows safer and more effective use of RAASi medications by managing potassium levels. This is a randomized, open-label clinical trial where eligible participants who have been hospitalized for heart failure worsening and have mild or at-risk hyperkalemia will be assigned to one of two groups. One group receives SZC along with standard RAASi treatment, while the other receives RAASi treatment alone without potassium binders. The treatment period lasts three months, during which RAASi doses are adjusted following European Society of Cardiology guidelines. Participants will be monitored from screening through three months of treatment to measure how many can increase their RAASi doses by at least 25%. Evaluations include clinical assessments, potassium level monitoring, and adherence to therapy. The study will also track secondary outcomes related to higher dose increases. Safety and treatment effects will be observed throughout the trial, which is expected to provide important insights for managing these conditions in elderly patients.

Researchers are evaluating Enzomenib DSP-5336, an oral drug, in patients with various types of acute leukemia, including relapsed or refractory acute myeloid leukemia AML, acute lymphocytic leukemia ALL, and acute leukemia of ambiguous lineage. The study also includes patients with high-risk myelodysplastic syndromes MDS and relapsed multiple myeloma MM in selected sites. This phase 12 trial aims to assess the safety, pharmacokinetics, pharmacodynamics, and clinical activity of DSP-5336 alone or combined with standard AML treatments, particularly in patients with specific genetic mutations like MLL rearrangement or NPM1 mutation. The study involves dose escalation and dose expansion of DSP-5336 administered orally. Participants may receive DSP-5336 alone or combined with standard AML regimens such as venetoclax plus azacitidine or intensive chemotherapy with cytarabine and daunorubicin 73. Different study arms include patients with or without certain medications like CYP3A4 inhibitor azoles, and those with specific genetic profiles. The trial evaluates recommended phase 2 doses for various patient groups and combination treatments. Participants will undergo assessments including monitoring for adverse events within 30 days after the last dose and evaluation of clinical responses approximately six months after treatment begins. Researchers will collect blood and bone marrow samples for genomic analysis and track drug levels in the body. Safety labs, ECGs, physical exams, and patient questionnaires will be performed throughout the study. The trial includes long-term follow-up of overall survival up to two years after treatment ends, with visits and tests scheduled to monitor health and treatment effects.

Researchers are conducting a prospective, multicenter observational study to create a registry for patients with unresectable locally advanced or metastatic breast cancer. This study includes patients diagnosed from January 2016 onwards, either at first diagnosis or after recurrence. Treatment choices are made independently by physicians, and the study does not specify any treatment regimen. The study groups are defined by breast cancer subtypes based on receptor expression, including Luminal A-like, Luminal B-like HER2 negative and positive, HER2-enriched, and Triple Negative subtypes. Since this is an observational study, patients receive standard care as determined by their doctors, and no intervention is assigned by the study. Participants medical records and disease management data will be collected and reviewed over an 8-year period. Researchers will evaluate the distribution of breast cancer subtypes, patient and tumor characteristics, hereditary risk factors, gender differences in disease progression, timing of primary tumor surgery, and biomarker presence in tumor and blood samples. Patients may withdraw consent at any time, and the study aims to follow patients until death or study completion.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating ITI-1284, a drug being studied for agitation associated with Alzheimers dementia. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ITI-1284 in patients aged 55 years and older who experience agitation related to Alzheimers disease. The study is sponsored by Intra-Cellular Therapies, Inc. and follows strict clinical criteria for diagnosis and agitation severity. Participants are randomly assigned in equal numbers to receive either ITI-1284 or a placebo. ITI-1284 is given as a rapidly disintegrating tablet taken once daily under the tongue at doses of 10 mg or 20 mg. The study consists of three periods a screening period lasting up to 4 weeks to assess eligibility, a 12-week double-blind treatment period where the assigned study drug is taken daily, and a 30-day safety follow-up period after the last dose to monitor any effects. During the study, participants will have assessments including the Cohen-Mansfield Agitation Inventory CMAI to measure agitation levels at Week 12. Other evaluations include the Clinical Global Impression-Severity CGI-S score and cognitive testing with the Mini-Mental State Examination. Safety monitoring occurs throughout the treatment and follow-up periods. Overall, participation lasts approximately 16 to 17 weeks, covering screening, treatment, and safety checks.

Researchers are evaluating ITI-1284, a study drug, for treating psychosis in patients with Alzheimers disease. This multicenter, randomized, double-blind study compares ITI-1284 with a placebo to assess its efficacy, safety, and tolerability in this population. The study includes patients diagnosed with Alzheimers disease and associated psychosis, focusing on improving psychosis symptoms as measured by specific scales. Participants will be randomly assigned to receive either ITI-1284 or a placebo during a 6-week double-blind treatment period. ITI-1284 is given as a 10 mg or 20 mg tablet taken once daily under the tongue. Before treatment, there is a screening period lasting up to 4 weeks to determine eligibility. After treatment, a safety follow-up visit occurs approximately 30 days later to monitor any effects. During the study, participants will undergo various assessments including psychosis rating scales BEHAVE-AD psychosis subscale and CGI-S score at baseline and Week 6. Researchers will monitor safety, tolerability, and adherence throughout treatment and follow-up. The total participation time includes screening, treatment, and the 30-day safety follow-up period, allowing detailed evaluation of the study drugs impact and participant well-being.

Researchers are conducting an observational study to assess patient satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in people with certain types of lung cancer and hepatocellular carcinoma. The study focuses on participants treated for approved indications in routine clinical practice across multiple countries and centers. It collects primary data on patient-reported outcomes and clinical effectiveness in real-world settings. Participants receive Atezolizumab as prescribed by their doctors for conditions including early-stage non-small cell lung cancer NSCLC after surgery and chemotherapy, metastatic NSCLC, extensive-stage small cell lung cancer ES-SCLC, and advanced or unresectable hepatocellular carcinoma HCC. Atezolizumab administration is at the physicians discretion and is independent of study participation. The study includes several cohorts based on cancer type and stage. During the study, participants report treatment satisfaction using the Therapy Administration Satisfaction Questionnaire Subcutaneous TASQ-SC at cycles 2 and 3, each lasting 3 weeks. Researchers also evaluate overall survival up to about 3.5 years, quality of life with the EORTC QLQ-C30 questionnaire, and record adverse events during the same period. The study aims to monitor patient experience, clinical outcomes, and safety over the long term, with participation lasting several years.

Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.

Researchers are evaluating RO7268489 as an add-on therapy to ocrelizumab in adults with progressive multiple sclerosis PMS. This phase II study aims to assess the safety, pharmacokinetics, pharmacodynamics, and effectiveness of RO7268489 in people with PMS, focusing on its impact on disability progression. Eligible participants have PMS and an Expanded Disability Status Scale EDSS score between 3.0 and 6.0. Participants are randomly assigned to receive one of three doses of RO7268489 or a placebo, all given alongside ocrelizumab following a predefined regimen. After the double-blind treatment phase, eligible participants may join an open-label extension to receive RO7268489 openly. The study uses a quadruple-blind design and compares these groups over approximately 110 weeks. During the study, participants will be regularly monitored for disability progression, brain volume changes, cognitive function, walking ability, hand function, and plasma levels of RO7268489 and its metabolites. Safety is tracked through adverse events and suicidal ideation assessments over up to five years. The study involves scheduled visits for treatment administration, assessments, and monitoring to thoroughly evaluate the impact of adding RO7268489 to ocrelizumab therapy.