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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.

Researchers are evaluating the safety and effectiveness of KarXT in preventing relapse of psychosis symptoms in people aged 55 to 90 years who have psychosis associated with Alzheimer's Disease. This Phase 3 study is randomized, double-blind, placebo-controlled, and conducted at multiple outpatient centers. The main goal is to compare relapse prevention between KarXT treatment and placebo over 38 weeks, while also assessing time to discontinuation, safety, and tolerability. Participants receive either KarXT in varying doses (ranging from 20 mg/2 mg to 66.7 mg/6.67 mg taken three times daily) or placebo capsules. The study lasts 38 weeks, during which participants remain on assigned treatment in an outpatient setting. The randomized, double-blind design ensures neither participants nor researchers know who receives KarXT or placebo during the study. Throughout the study, participants will visit the clinic regularly for assessments of their psychosis symptoms, safety checks, and overall health. Researchers will track the time to relapse of psychosis symptoms as the primary outcome. They will also monitor safety and tolerability through clinical examinations and other evaluations. The total duration of participation is 38 weeks from randomization to the end of the study period.

Researchers are investigating the effectiveness and safety of KarXT combined with KarX-EC in treating cognitive problems associated with mild to moderate Alzheimer's Disease. This phase 3 study focuses on patients diagnosed according to the National Institute on Aging and Alzheimer's Association criteria, targeting those with specific dementia stages and confirmed disease pathology. The goal is to assess whether this combination therapy can improve cognitive function in this population. Participants will receive either KarXT and KarX-EC together or a placebo, with doses given on specified days during the study. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active treatment or placebo during the trial. The treatment period lasts up to 24 weeks to evaluate the effects of these medications on cognitive impairment. During the study, participants will be closely monitored through cognitive assessments including the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 and the Clinician's Interview-Based Impression with caregiver input, both measured at 24 weeks. Caregivers play an important role by maintaining regular contact, reporting on the participant's condition, and helping with medication adherence. Safety and cognitive function will be regularly evaluated to understand the impact of the treatment over the study period.

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 evaluating the safety and effectiveness of a drug called MEDI0618 compared to a placebo in adults with episodic migraine. This Phase 2 study includes participants aged 18 to 70 years who have a history of migraine headaches, including those who have tried and failed at least two small molecule migraine preventive treatments. The study also enrolls participants who have either not yet received or have failed treatment with anti-calcitonin gene-related peptide (aCGRP) therapies. Participants receive subcutaneous injections of MEDI0618 or a placebo in a randomized, double-blind design. The study is conducted across multiple centers, with parallel treatment groups. It focuses on reducing the number of migraine headache days by comparing the effects of repeat doses of MEDI0618 to placebo over the treatment period. During the study, participants will track their migraine headache days and other relevant symptoms. Researchers will assess the efficacy of MEDI0618 in preventing migraine headaches between weeks 9 and 12. Safety, tolerability, and other health measures will be monitored throughout the study to ensure participant well-being. The total participation period includes baseline data collection followed by the treatment and evaluation phases.

Researchers are evaluating ACP-204, a drug that blocks a specific serotonin receptor, in adults aged 55 to 95 with Alzheimer's Disease Psychosis (ADP). The study is designed as a master protocol with three independent, multicenter, randomized, double-blind, placebo-controlled trials. The trials include Phase 2 and Phase 3 studies to assess the drug's effectiveness and safety in treating psychotic symptoms associated with ADP. The research involves three substudies. Substudy 1 (Phase 2) tests two doses of ACP-204, 30 mg and 60 mg, against a placebo to evaluate dose response. Substudies 2A and 2B (both Phase 3) will independently confirm the effects of either both doses or a single dose from Part 1 compared to placebo. Each substudy includes a screening period of up to 49 days, a six-week double-blind treatment phase, and a 30-day safety follow-up for those not continuing into an open-label extension. Vital status follow-up is conducted for participants who end the study early. Participants will receive regular assessments, including evaluations of psychotic symptoms using the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales from baseline to Week 6. Other study involvement includes brain imaging scans and biomarker tests to confirm Alzheimer's disease diagnosis, cognitive testing, and monitoring of safety and vital status throughout the study periods. Stable living arrangements and support from a caregiver are required to complete all study visits.

Researchers are conducting a national, prospective, multicenter observational pilot project in the Czech Republic focused on screening for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) in patients after an episode of Acute Pulmonary Embolism (APE). The main aim is to develop, test, and implement a standardized procedure for early detection of CTEPH and ensure rapid referral to specialized centers treating this condition. Early detection and timely treatment are important to improve patients' quality of life and reduce the risk of complications or death. The study uses a standardized CTEPH screening protocol designed to identify patients after APE who may have or develop CTEPH. This includes implementing a uniform screening algorithm and optimizing the referral process to specialized pulmonary hypertension centers. The project plans to include around 500 patients across about 10 selected centers, focusing on validating the screening process and patient flow from cardiologists to pulmonary hypertension treatment centers. Participants will be followed for up to six months from enrollment. Researchers will assess the positive predictive value of the initial examination, the rate of detecting CTEPH, and how many patients with suspected CTEPH attend follow-up exams at specialized centers. The study involves monitoring patients' symptoms, risk factors, and screening outcomes to evaluate the effectiveness and feasibility of the screening approach.

The trial investigates the long-term safety and tolerability of KarXT in people with psychosis associated with Alzheimer's Disease. This Phase 3 global, multicenter, open-label extension study lasts 52 weeks and enrolls participants who have completed earlier related studies (CN012-0026, CN012-0027, or CN012-0056). The purpose is to monitor how well patients tolerate KarXT over an extended period and to collect safety data. Participants receive KarXT in varying doses taken three times daily, ranging from 20/2 mg up to 66.7/6.67 mg per dose, corresponding to total daily doses between 60/6 mg and 200/20 mg. This treatment is provided throughout the 52-week open-label extension. The study includes only those who completed the previous related studies and continues to assess their response to KarXT over this longer timeframe. During the study, participants are closely monitored for treatment-emergent adverse events from the first dose through 14 days after the final dose, which may be up to 54 weeks. Regular assessments ensure safety and tolerability, and caregivers are involved to support participants. The study also evaluates participants' ability to continue living in their current setting and requires consent from the participant or their legal representative. Overall, the study tracks long-term safety outcomes in this specific patient group.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety and effectiveness of ACP-204 in adults with Lewy Body Dementia Psychosis (LBDP). Participants eligible for this study are adults aged 55 to 84 years who meet specific clinical criteria for Parkinson's disease dementia or probable dementia with Lewy bodies, along with psychosis criteria established for neurocognitive disorders. Participants will be assigned to receive either ACP-204 or a placebo, each provided as one capsule taken orally once daily for six weeks. This parallel-group study maintains blinding to ensure unbiased assessment of the treatment effects over the 6-week period. During the study, researchers will monitor changes from baseline in the SAPS-LBDP total score at Week 6 to assess psychosis symptoms. Participants will undergo various evaluations and assessments to ensure safety and adherence throughout the study duration, with detailed criteria guiding enrollment and exclusion to maintain participant well-being.

This research aims to evaluate the effectiveness, safety, and tolerability of atogepant, a medicine approved for preventing migraine, when used to treat migraine attacks quickly. The study focuses on adults aged 18 to 75 years who have a history of moderate to severe migraine attacks. It includes a double-blind phase where neither participants nor doctors know who receives atogepant or placebo, followed by an open-label phase where everyone receives atogepant. The study is conducted at about 160 sites worldwide with around 1300 participants. Participants will receive both atogepant and placebo in a random sequence to treat qualifying migraine attacks during the double-blind phase. After treating four migraine attacks this way, participants will enter an open-label phase lasting until week 24, during which they will receive atogepant for any additional migraine attacks. Treatments are given as oral tablets. Throughout the study, participants will attend regular hospital or clinic visits and telephone check-ins. They will complete electronic diaries with questionnaires about their migraines and treatment effects. Medical assessments, blood tests, and monitoring for side effects will be conducted. The main outcome measured is the percentage of participants who experience freedom from pain two hours after taking the study medication for their first treated migraine attack, observed over about 16 weeks.