Whitby

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.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 years who have mild to severe Alzheimers Disease AD with moderate to severe psychosis related to AD. This Phase 3 study aims to compare KarXT with a placebo to see how well it works in treating psychosis symptoms associated with AD, focusing on changes in hallucinations and delusions. Participants will receive either KarXT capsules at varying doses or placebo capsules in a randomized, double-blind setup. The treatment period lasts up to 14 weeks, during which participants take the assigned capsules daily. The study design includes two groups running in parallel, with neither participants nor researchers knowing who receives the drug or placebo. During the study, participants will undergo assessments including the Neuropsychiatric Inventory-Clinician NPI-C focusing on hallucinations and delusions, Clinical Global Impressions-Severity scale, and other related scales to measure psychosis symptoms and caregiver distress. Safety and efficacy will be monitored throughout, with evaluations at baseline and at the end of treatment. The entire participation period extends up to 14 weeks.

Researchers are evaluating the safety and effectiveness of combining KarXT and KarX-EC as a treatment for psychosis associated with Alzheimers disease. This Phase 3 randomized, double-blind, placebo-controlled trial aims to address psychotic symptoms such as hallucinations and delusions in patients aged 55 to 90 diagnosed with Alzheimers disease according to recent criteria. The study is sponsored by Bristol-Myers Squibb and uses a parallel group design to compare the investigational drug combination against placebo. Participants will be randomly assigned to receive either the combination of KarXT plus KarX-EC or a matching placebo, with specified doses given on set days. The treatment period lasts approximately 14 weeks, during which safety and efficacy are closely monitored. The trial assesses changes from baseline in neuropsychiatric symptoms and other clinical measures using standardized scales and questionnaires. During the study, participants will undergo various assessments including clinical evaluations, laboratory tests, brain imaging review, and symptom rating scales such as the Neuropsychiatric Inventory-Clinician and Clinical Global Impressions-Severity. Researchers will also monitor adverse events and other health indicators up to about week 14. The total participation duration spans from screening through treatment completion and safety follow-up to evaluate the overall impact and safety profile of the treatments.

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.

Alport syndrome AS is a rare genetic disorder caused by changes in specific genes that produce collagen, leading to kidney disease, hearing loss, and eye problems. People with AS face a high risk of chronic kidney disease CKD, which gradually reduces kidney function and can lead to end-stage kidney disease. A common sign of worsening kidney function is proteinuria, the presence of excess protein in the urine. This study evaluates the effects of BAY 3401016, a monoclonal antibody designed to block the protein Semaphorin 3A Sema3A, which may contribute to kidney damage in AS. Participants are randomly assigned to receive either BAY 3401016 or a placebo once weekly for 24 weeks, alongside their background therapy. The study includes an extension phase to further assess the treatments safety and efficacy. Participants will be involved for at least 24 weeks of treatment, followed by a 90-day follow-up period. Researchers will monitor kidney function by measuring the urinary albumin creatinine ratio UACR at several points during treatment and after its completion. Safety and tolerability of BAY 3401016 will also be carefully assessed throughout the study period.

Researchers are evaluating the use of intravenous hyperoncotic albumin compared to normal saline boluses in critically ill patients suffering from Acute Kidney Injury requiring renal replacement therapy AKI-RRT. This trial aims to determine whether albumin administration during renal replacement therapy sessions increases organ support-free days and renal replacement therapy-free days within 28 days after randomization. The study addresses the challenge that renal replacement therapy, while life-saving, may cause complications like hypotension and organ ischemia in these patients. Participants will be randomly assigned to receive either 20-25% albumin fluid or normal saline boluses during their renal replacement therapy sessions in the intensive care unit. Each treatment involves two 100 mL boluses one at the start and one halfway through each session. The renal replacement therapies include continuous renal replacement therapy CRRT, prolonged intermittent renal replacement therapy PIRRT, or intermittent hemodialysis IHD. Treatments will continue for up to 14 days in the ICU, with dosing schedules tailored to the type of renal replacement therapy. During the study, participants will be closely monitored for organ support-free days, renal replacement therapy-free days, and other health outcomes through 28 days, with extended follow-up for mortality and kidney function up to 365 days. Researchers will collect data on fluid balance, hypotension episodes during therapy, organ function scores, healthcare costs, and quality of life measures. The trial involves multiple intensive care units and includes comprehensive assessments to evaluate the impact and safety of albumin use in this critical condition.

Mood disorders, including depression and bipolar disorder, affect over 350 million people worldwide. Matching the right treatment to each individual is challenging and can lead to prolonged illness and reduced quality of life. This research aims to advance the search for biomarkersclinical tests, blood tests, or imagingthat can help diagnose and treat mood disorders by creating a large, standardized study platform called ENABLE. The ENABLE platform provides standardized methods to collect detailed clinical and neurobiological data from individuals aged 16 and older with mood disorder symptoms. Participants complete clinical assessments and may opt for additional tests such as blood samples, MRI and EEG scans, cognitive tasks, and wearing an activity monitor for two weeks. The platform also serves as a recruitment pool for future biomarker-based clinical trials and offers open-source data for research purposes. Participants will undergo tiered assessments, with tier 1 including required clinical interviews and questionnaires, and tier 2 offering optional neuroimaging, blood collection, cognitive testing, and actigraphy. Researchers will measure participation rates and collect data to support biomarker discovery. The study involves ongoing data collection and follow-up until March 2029, providing a resource for future clinical trials and scientific analyses.

This trial studies whether cannabidiol CBD capsules can help manage agitation in patients with Alzheimers disease AD. It is a randomized, double-blind, placebo-controlled crossover study assessing the safety and effectiveness of CBD, while also exploring new biomarkers related to agitation severity and treatment response. Agitation is common in AD and linked to health problems and caregiver burden current treatments have limitations and safety concerns. Participants will receive either CBD or placebo capsules during two treatment phases, each lasting 8 weeks, separated by a 2-week placebo washout period. The CBD dose is gradually increased up to a maximum of 800 mg per day. The study involves 12 visits approximately every 2 weeks and 8 weekly telephone visits throughout the 19-week treatment period, followed by 4 weeks of observation after treatment ends. During the study, participants will undergo assessments of agitation using the Cohen-Mansfield Agitation Inventory and other evaluations including neuropsychiatric symptoms, caregiver distress, cognition, nutritional status, weight, pain, and overall global change. Researchers will monitor these outcomes from baseline through 22 weeks to understand CBDs impact and safety in managing agitation in AD patients.

Researchers are evaluating whether nabilone, a synthetic cannabinoid approved for chemotherapy-related nausea, is an effective treatment for agitation in patients with Alzheimers disease AD. Agitation is common in AD and can worsen quality of life, increase caregiver burden, and speed institutionalization. Current treatments have limited effectiveness and notable risks, so this study aims to explore nabilones potential benefits for agitation and other symptoms in AD. Participants will be randomly assigned to receive either nabilone or placebo capsules for 8 weeks. Those in the nabilone group will have their dose gradually increased up to a maximum of 2 mg per day. After the treatment phase, all participants will be followed for an additional 8 weeks to monitor ongoing effects. The study uses a quadruple-blind design to compare outcomes between the two groups. During the study, participants will undergo assessments of agitation using the Cohen-Mansfield Agitation Inventory, as well as evaluations of behavior, cognition, weight, nutritional status, pain, and global clinical change. Caregivers will also participate in study visits and assessments. The research team will closely monitor these factors from the start through 8 weeks after treatment ends to understand the effects and safety of nabilone in this population.

This research focuses on people with psychosis linked to Alzheimers Disease who have completed earlier studies CN012-0026, CN012-0027, or CN012-0056. It is a Phase 3 global, multicenter, open-label extension study lasting 52 weeks that aims to evaluate the long-term safety and tolerability of KarXT in this population. Participants will receive KarXT capsules containing Xanomeline and Trospium Chloride. The study includes various dosing levels ranging from 202 mg to 66.76.67 mg taken three times daily. This open-label extension follows completion of previous studies and continues for up to 54 weeks from the initial dose, including a 14-day safety follow-up after the final dose. During the study, participants will be monitored for treatment-emergent adverse events and serious adverse events. Safety assessments include clinical evaluations throughout the treatment and 14 days after the last dose. The total participation time is approximately one year, allowing researchers to understand long-term effects of KarXT in this group.