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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.

This trial studies adults aged 55 to 90 who have psychosis linked to Alzheimers Disease. It is a Phase 3, 38-week, randomized, double-blind, placebo-controlled outpatient study. Its main goal is to assess how well KarXT capsules prevent relapse of psychosis compared to placebo. Additional goals include evaluating time to treatment discontinuation or relapse, and monitoring safety and tolerability. Participants receive either KarXT capsules at various doses or placebo capsules. The study involves a randomized assignment and is conducted under quadruple masking. The treatment period lasts 38 weeks during which KarXT or placebo is taken three times daily. Assessments continue up to approximately 42 weeks to monitor adverse events and other safety measures. Throughout the study, participants attend outpatient visits for evaluations including cognitive tests, assessments of psychosis severity, caregiver reports, lab tests, vital signs, and safety monitoring. Researchers measure relapse timing, treatment discontinuation, neuropsychiatric symptoms, movement scales, weight, and signs related to heart and urinary health. Safety is closely tracked with various assessments until about week 42.

Researchers are studying the effects of KarXT combined with KarX-EC to treat cognitive impairment in people with mild to moderate Alzheimers Disease. This Phase 3 clinical trial aims to evaluate both the efficacy and safety of this treatment compared to a placebo, focusing on improving cognitive function and daily living activities over 24 weeks. Participants will be randomly assigned to receive either the active drugs KarXT and KarX-EC or a placebo, following specified dosing schedules. The study uses a double-blind, parallel-group design, meaning neither the participants nor the researchers know who receives the active treatment or placebo during the trial period. Participants will be monitored through various assessments including cognitive scales like the Alzheimers Disease Assessment Scale-Cognitive Subscale 11 ADAS-Cog11 and clinician interviews at baseline and week 24. Safety will be closely observed via monitoring adverse events, vital signs, laboratory tests, and heart function tests. The total duration of participation includes treatment and follow-up until study completion.

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 conducting a Phase 2 study to assess the safety and effectiveness of a drug called MEDI0618 compared to a placebo in adults with episodic migraine. The study includes participants who have not responded to at least two different small molecule migraine preventive treatments and are either eligible but have not used aCGRP therapies or have previously failed one or more aCGRP preventive treatments. This research aims to improve migraine prevention options for these individuals. Participants will receive subcutaneous injections of MEDI0618 or placebo in a double-blind, randomized design. The study has multiple dosing arms including Dose A and three additional doses for the group not previously treated with aCGRP therapies, with participants assigned in a 11 ratio to either active drug or placebo. A separate group who have failed aCGRP therapies will also be randomized 11 to receive MEDI0618 or placebo. The treatment period includes repeated dosing and evaluation of the drugs impact on migraine occurrence. Throughout the study, participants will be monitored for migraine headache days and the severity and disability caused by migraines from baseline through treatment. Evaluations will occur regularly from Day 1 to Day 141, including assessments focusing on migraine frequency between Weeks 9 and 12. Safety and efficacy will be closely observed in a controlled setting, and the study is expected to conclude in May 2027.

Researchers are evaluating ACP-204, a drug targeting serotonin receptor subtype 2A, in adults aged 55 to 95 years with psychosis related to Alzheimers disease. This master protocol includes three independent, randomized, double-blind, placebo-controlled studies aimed at assessing the drugs efficacy and dose response. Substudy 1 is a Phase 2 trial comparing two doses of ACP-204 30 mg and 60 mg to placebo, followed by two Phase 3 confirmatory studies Substudies 2A and 2B that will independently evaluate the doses or a selected dose against placebo. Participants will undergo a screening period lasting up to 49 days before starting a six-week double-blind treatment phase where they will receive daily doses of ACP-204 or placebo, taken once a day at about the same time with or without food. After treatment, there is a 30-day safety follow-up for those not entering an open-label extension, and vital status follow-up for those who end the study early. Each substudy is analyzed separately to assess the drugs impact. During the trial, participants are closely monitored with assessments including the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions SAPS-HD from baseline to week 6. Other evaluations include clinical global impression scales and safety monitoring. Participants must have a study partner or caregiver to assist with visits and adherence. The study is designed to track changes in psychosis symptoms and overall safety through the treatment and follow-up periods.

This research aims to develop, test, and implement a standardized process for early detection of Chronic Thromboembolic Pulmonary Hypertension CTEPH in patients who have had an acute pulmonary embolism APE. It is a national, prospective, multicenter observational pilot project conducted in the Czech Republic. The goal is to improve patient outcomes by enabling timely treatment and to ensure the process is cost-effective and beneficial to the population. Patients who have experienced APE within the past 3 to 12 months and meet specific criteria will undergo a standardized screening protocol to identify early signs of CTEPH. Those found to be at risk will be quickly referred to specialized centers for further evaluation and management. The project plans to involve about 500 patients across approximately 10 selected centers. Participants will be monitored for up to six months from enrollment, during which researchers will assess the accuracy of the screening protocol, the rate of CTEPH detection, and the proportion of patients who follow up at specialized treatment centers. The study includes patient evaluations, data collection on symptoms and risk factors, and referral pathways to ensure rapid access to specialized care. The study is supported by the European Social Fund and the Czech Republics state budget.

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.

Researchers are evaluating the efficacy and safety of ACP-204 in adults aged 55 to 84 years with Lewy Body Dementia Psychosis LBDP. This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study designed to assess the impact of ACP-204 on psychosis symptoms associated with LBDP. The study aims to provide insights into treatment options for this condition with significant cognitive and psychiatric features. Participants are randomly assigned to one of three groups ACP-204 30 mg once daily, ACP-204 60 mg once daily, or placebo once daily. The study treatment is provided as capsules taken orally each day over a 6-week period. The trial is conducted with quadruple masking to maintain blinding of participants and researchers. The primary focus is to compare changes in psychosis symptoms using the SAPS-LBDP total score over the 6 weeks of treatment. During the study, participants will be monitored closely with regular assessments to evaluate changes in psychosis symptoms. Researchers will collect data on safety and efficacy throughout the 6-week treatment period. Participants must be able to provide consent or have a legally authorized representative assist with consent. The overall duration of participation is approximately 6 weeks, with careful monitoring to ensure adherence and safety.