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Found 3 Actively Recruiting clinical trials
Actively Recruiting
This research aims to evaluate the safety and tolerability of Zunveyl in adults aged 50 years and older who have mild to moderate Alzheimers disease. The study focuses on measuring neuropsychiatric symptoms and caregiver distress, providing important information about the effects of this treatment in a real-world clinical setting. It is a Phase 4, open-label study sponsored by Alpha Cognition, Inc, designed to assess routine clinical use over 12 weeks. Participants will take Zunveyl delayed release oral tablets starting at 5 mg twice daily for the first 4 weeks, then increasing to 10 mg twice daily for weeks 5 through 12. This single-group study involves no placebo or comparator arm. The treatment period spans 12 weeks, during which participants receive the medication and are monitored for safety and symptom changes. Throughout the study, participants and their caregivers will attend scheduled visits to assess adverse events, tolerability, neuropsychiatric symptoms using the Neuropsychiatric Inventory - 12 Domain NPI-12, and caregiver distress. Safety monitoring includes tracking serious adverse events, treatment interruptions, and dose reductions up to week 12, with global tolerability scores collected at multiple timepoints. The total participation lasts at least 17 weeks to include follow-up assessments after treatment completion.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.
Actively Recruiting
Researchers are evaluating the efficacy, safety, tolerability, and pharmacokinetics of VX-147 in adults and children aged 10 to 65 who have APOL1-mediated proteinuric kidney disease. This study includes participants with specific APOL1 genotypes and aims to understand how VX-147 affects kidney function over time in this population. Participants are randomly assigned to receive different doses of VX-147 or a matching placebo. Those in the initial phase Part A will receive their assigned treatment for at least 96 weeks. Participants who complete Part A will then receive VX-147 for an additional 96 weeks in Part B. The study uses tablets taken orally and includes a placebo control group. During the trial, participants will be monitored regularly for changes in urine protein to creatinine ratio and kidney function measured by estimated glomerular filtration rate eGFR. Safety and tolerability are assessed through tracking adverse events throughout the study, which may last around four years after the last participant enrolls. Blood levels of VX-147 will also be measured, and pediatric participants will be asked about their satisfaction with the tablet form.