Razgrad

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to address agitation symptoms in this population by comparing the investigational drugs with a placebo. The study is sponsored by Bristol-Myers Squibb and uses established diagnostic criteria for Alzheimers Disease. Participants will receive either the combination of XanomelineTrospium Chloride capsules KarXT KarX-EC or a placebo with specified doses on designated days. The study includes a parallel group design and treatment lasts for 14 weeks. The main focus is to assess changes in agitation using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association CMAI-IPA total score. During the study, participants will undergo regular assessments including cognitive and behavioral evaluations, safety monitoring through vital signs, laboratory tests, electrocardiograms, and rating scales for movement disorders and suicidal ideation. Caregivers will be involved to help monitor participant status and medication compliance. The primary outcome is measured at Week 14, with safety follow-up extending to Week 18. Participants are expected to be engaged throughout the treatment period and follow-up assessments.

This research aims to evaluate the long-term efficacy and safety of a combined formulation of xanomeline tartratetrospium chloride in an immediate release capsule KarXT and xanomeline enteric capsules KarX-EC for treating agitation in participants with Alzheimers Disease. The study focuses on individuals who have completed prior parent studies CN012-0023 or CN012-0024 and seeks to understand treatment effects over an extended period. Participants will receive specified doses of KarXT and KarX-EC on designated days as part of this single-group, non-randomized study. The treatment phase lasts up to approximately 30 weeks, during which the combined drugs are administered and monitored for safety and effectiveness related to agitation management in Alzheimers Disease. Throughout the study, participants will be monitored for treatment-emergent adverse events and other safety measures. Assessments include tracking adverse events, serious adverse events, changes in vital signs, laboratory evaluations, electrocardiograms, cognitive function tests like the Mini-mental State Examination and ADAS-Cog-13, as well as symptom severity scales. Caregiver involvement is required to provide support and facilitate study participation. The total study duration extends up to about 30 weeks with ongoing safety and efficacy evaluations.

This research aims to compare two asthma inhalers that use different propellants in people with mild to moderate asthma. The study evaluates whether an investigational inhaler with a new climate-friendly propellant, HFA-152a, works as safely and effectively as inhalers using the existing HFA-134a propellant. This global Phase II study plans to enroll 468 patients in Europe, Latin America, Ukraine, South Africa, and the United Kingdom. Participants will use one of three inhaler treatments in a randomized, double-blind crossover design the investigational CHF5993 pMDI with HFA-152a, CHF5993 pMDI with HFA-134a, or CHF718 pMDI with HFA-134a. Each inhaler is taken as two puffs twice daily. The study compares lung function effects of these inhalers during treatment periods. During the trial, participants will be assessed for lung function through measurements like forced expiratory volume in 1 second FEV1 at baseline and after treatment. Researchers will monitor safety, treatment adherence, and asthma control over the study period. Participants undergo scheduled visits for these evaluations, with the study expected to complete in June 2027.