Stafford

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimer's Disease. This phase 3 study aims to better understand how these treatments impact agitation symptoms in this population by comparing them to a placebo group. Participants must have a confirmed Alzheimer's diagnosis and meet specific criteria for agitation severity to join the study. Participants will receive either the Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, or a placebo, each given at specified doses on designated days. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison of treatment effects. The treatment period lasts through Week 14, during which dosing schedules are closely followed. Throughout the study, participants will be regularly assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) to measure changes in agitation levels from baseline to Week 14. Caregivers will provide reports on participant status and help ensure medication compliance. Safety and symptom changes will be carefully monitored to evaluate the treatments' effects during this period.

Multiple myeloma is a cancer affecting plasma cells in the bone marrow. Researchers are evaluating how well Immune Globulin Infusion (human), 10% (IGI, 10%) can help prevent infections in adults with multiple myeloma receiving B-cell maturation antigen (BCMA) x CD3-directed bispecific antibody therapy. This phase 3 study aims to compare primary infection prevention using IGI, 10% versus secondary infection prevention in this patient group. Participants will be randomly assigned to one of two groups: the primary infection prevention group will receive IGI, 10% infusions for 12 months, while the secondary infection prevention group will receive IGI, 10% only if they develop a serious infection during the 12-month study period. The IGI, 10% is given intravenously. The study includes a screening period of up to 8 weeks, followed by treatment and monitoring. During the study, participants will attend 15 clinic visits if on a 4-week dosing schedule or 19 visits if on a 3-week dosing schedule, with total participation lasting up to 14 months. Researchers will monitor the time to first serious infection over 12 months. Participants will undergo evaluations to assess infection status and treatment safety throughout the study.

This trial focuses on people aged 55 to 90 who have agitation related to Alzheimer's Disease and previously finished one of two earlier studies. It aims to assess the long-term safety and effectiveness of a combination treatment using xanomeline tartrate/trospium chloride immediate release capsules (KarXT) and xanomeline enteric capsules (KarX-EC) in these participants. The study is a Phase 3 open-label extension, meaning all participants receive the treatment while researchers observe effects over time. Participants receive specified doses of KarXT and KarX-EC on set days as part of the treatment regimen. The study follows those who completed the earlier parent studies CN012-0023 or CN012-0024, continuing to monitor their response to the combined medication over an extended period. Throughout the study, researchers evaluate the number of participants who experience any treatment-emergent adverse events up to about 30 weeks. Caregiver involvement is required, with at least one caregiver having regular contact of about 10 hours per week or more. Safety and tolerability are closely monitored to understand the long-term impact of the treatment in managing agitation associated with Alzheimer's Disease.

Researchers are studying how to improve the accuracy of MRI scans in identifying early-stage rectal cancer and significant rectal polyps. Early-stage rectal cancers grow partially into the bowel wall and can often be treated with local procedures that preserve the bowel, avoiding major surgery and its risks. Many patients are currently over-treated due to inaccurate MRI staging, leading to unnecessary major surgery or radiotherapy. The study focuses on a new MRI reading method called PRESERVE that has shown higher accuracy in identifying early rectal cancers suitable for local excision. The study involves training radiologists across 20 hospitals in the PRESERVE MRI reading method to better stage early rectal cancers and significant polyps. MRI scans are recommended before removal of rectal polyps that are 20mm or larger or have features suspicious for cancer. Radiologists will be trained to use the PRESERVE system to improve diagnostic accuracy and help guide treatment choices, aiming to increase the number of patients offered organ-preserving surgery. Participants will be monitored by comparing MRI reports before and after the radiologist training over one year. Researchers will measure the impact of the training on the accuracy of tumor staging and whether more patients receive local procedures instead of major surgery. This study will help determine if the new approach can be widely adopted to improve patient outcomes and preserve quality of life.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant (ASCT). This phase III, open-label, randomized, controlled study aims to evaluate whether adding a proteasome inhibitor to the salvage ASCT conditioning improves the depth of response, and to assess the impact of consolidation and maintenance treatments on the durability of response. The study also looks at overall survival, progression time, quality of life, and treatment safety among participants with measurable disease and good performance status. All participants first receive re-induction therapy consisting of 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone (ITD) over 28-day cycles to achieve maximum disease control. Those who reach stable disease or better are randomized to receive either conventional ASCT using melphalan or augmented ASCT combining melphalan with ixazomib. Following this, participants who maintain minimal response or better undergo a second randomization to either receive consolidation therapy with 2 cycles of ITD followed by ixazomib maintenance until disease progression, or no further treatment. During the study, participants will undergo regular assessments including blood tests, disease response evaluations, and monitoring for adverse effects. The primary outcomes measured are overall response rate 100 days after ASCT and progression-free survival up to 10 years. Secondary evaluations include overall survival, time to disease progression, minimal residual disease status at various stages, engraftment kinetics, and quality of life. Follow-up continues with clinic visits every three months until disease progression is observed, enabling long-term monitoring of treatment effects and safety.