Chertsey

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation related to Alzheimers Disease. This Phase 3 study aims to understand how these medications impact agitation symptoms in this population, using recognized criteria to confirm Alzheimers diagnosis and agitation severity. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. Dosing is specified for certain days, and the study includes a 14-week treatment period during which agitation and other symptoms will be closely monitored. The study design includes a quadruple-blind method to reduce bias. During the study, participants and their caregivers will attend regular visits where the researchers will assess changes in agitation using tools like the Cohen-Mansfield Agitation Inventory and Clinical Global Impressions-Severity scale. Safety will also be carefully monitored through various assessments including vital signs, lab tests, ECGs, and movement scales. Participant involvement extends up to 18 weeks to capture any adverse events and treatment effects.

Researchers are evaluating brenipatide alongside buprenorphine, with or without naloxone, to assess its safety and effectiveness in people with opioid use disorder. This Phase 2 study includes two separate participant groups Part A involves a double-blind treatment phase with a later open-label extension, and Part B features an open-label treatment phase. Participants join only one part of the study. In Part A, participants receive either brenipatide or a placebo by subcutaneous injection plus buprenorphine taken under the tongue or inside the cheek. Part B participants receive open-label brenipatide injections with buprenorphine. The maximum study participation duration is about 144 weeks for Part A and 116 weeks for Part B, depending on enrollment timing and pace. Treatments are given as subcutaneous injections and transmucosal buprenorphine. Participants will attend regular study visits to monitor opioid use through urine drug screens and self-reports, track adherence to buprenorphine, and assess cravings and quality of life. Other measurements include changes in body weight, blood pressure, and healthcare visits. Safety is monitored throughout, and the main outcome focuses on weeks of abstinence from opioid use between weeks 13 and 24. Total participation time varies with study part and enrollment timing.

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III study aims to better understand the impact of trontinemab on cognitive decline and daily functioning in this population. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will be assigned to receive either intravenous trontinemab or an intravenous placebo. The treatment period lasts up to 72 weeks, during which participants receive infusions as scheduled. Assessments include brain imaging such as amyloid and tau PET scans, cerebrospinal fluid and blood biomarker collection, and cognitive testing. The study also monitors safety through tracking adverse events, infusion-related reactions, and anti-drug antibodies. Participants will attend visits for evaluations including clinical dementia rating, cognitive scales like MMSE and ADAS-Cog-13, and daily living activities assessments. Safety monitoring involves MRI scans and lab tests. The primary outcome measured is the change in Clinical Dementia Rating, Sum of Boxes CDR-SB, from baseline to Week 72. The total duration of participation extends through the 72-week treatment and assessment period, with ongoing safety evaluations.

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.

Researchers are evaluating treatments for symptomatic Alzheimers Disease in a Phase 3 trial designed to measure sustained clinical response over 18 months. The study uses a multi-arm, multi-stage adaptive design to compare standard care plus placebo, atomoxetine, or metformin in participants representative of the UK Alzheimers population. The trial aims to assess changes in cognitive function and daily living activities, with additional focus on symptoms, quality of life, caregiver impact, safety, and economic outcomes. Participants are randomly assigned to one of three groups receiving standard care plus either a placebo capsule, oral atomoxetine up to 100 mg daily, or oral metformin up to 2000 mg daily. The trial includes interim analyses at several stages to decide if any treatment arm should be stopped early due to lack of activity. Blood biomarkers and MRI scans are also collected to explore disease progression and treatment effects. During the study, participants will undergo assessments including cognitive tests, daily living activity questionnaires, neuropsychiatric evaluations, quality of life surveys, and caregiver burden measures at baseline and throughout 18 months. Safety is monitored by tracking adverse events and health resource use. MRI imaging and blood samples are used for exploratory analyses. Participants are expected to adhere to treatment and assessment schedules, with regular visits for evaluation and monitoring throughout the trial period.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are conducting a multi-centre observational study to better understand giant cell arteritis GCA and polymyalgia rheumatica PMR, conditions mainly affecting people over 50 years old. The study aims to identify genetic factors that influence susceptibility to these diseases to provide new insights into how they develop. It includes both retrospective participants with confirmed diagnoses and prospective participants suspected of having these conditions, with some patients also enrolled in a registry monitoring tocilizumab treatment for relapsing or refractory GCA. The study collects detailed clinical, imaging, and molecular data, including genetic and proteomic analyses, from participants to characterize disease subtypes and impacts. Researchers also assess quality of life through patient-reported outcomes and track long-term prognosis by linking to health records. The study explores environmental factors and co-existing conditions to improve diagnosis, prognosis, and monitoring of disease activity, especially for patients receiving synthetic or biological disease-modifying anti-rheumatic drugs. Participants provide information during baseline assessments, including blood and urine samples for analysis, and complete questionnaires about their symptoms and quality of life. Follow-up occurs through health record review over an average of one year to evaluate diagnosis and disease outcomes. The primary measure is genetic susceptibility, with secondary outcomes focusing on disease characteristics, life impact, diagnosis, and disease activity. The study is sponsored by the University of Leeds and started in 2005, continuing through 2028.

Researchers are evaluating lunsekimig, a subcutaneous injection, compared with placebo in adults aged 40 to 80 years with inadequately controlled Chronic Obstructive Pulmonary Disease COPD characterized by an eosinophilic phenotype. This Phase 2bPhase 3 parallel study aims to assess the efficacy, safety, and tolerability of lunsekimig in reducing COPD exacerbations and improving lung function and symptoms. Participants are randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. They will receive subcutaneous injections during a 48-week treatment period. The study also includes a screening period of up to 4 weeks before treatment and an approximately 8-week follow-up period after treatment, totaling up to 60 weeks of participation. During the study, participants will undergo regular assessments including lung function tests such as post- and pre-bronchodilator Forced Expiratory Volume in 1 second FEV1, questionnaires measuring respiratory health and symptoms, and monitoring of COPD exacerbations. Safety will be evaluated through reported adverse events and laboratory tests. Researchers will also monitor blood levels of lunsekimig and the presence of antidrug antibodies. Participants will be followed closely throughout the study duration to assess treatment impact and safety.