Wichita

Researchers are investigating whether buntanetap/Posiphen can help treat early Alzheimer's disease in adults aged 55 to 85 years. This Phase 3 study aims to find out if buntanetap/Posiphen improves thinking abilities and daily functioning compared to a placebo. It also evaluates the safety of buntanetap/Posiphen by monitoring any medical issues that participants may experience during the trial. Participants will take either a 30 mg capsule of buntanetap/Posiphen or a placebo capsule by mouth once daily for 18 months. The study includes regular clinic visits at screening, enrollment, and months 1, 3, 6, 9, 12, 15, and 18. During some visits, participants will have brain MRI scans. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Throughout the study, participants will complete tests and questionnaires to measure cognitive function and daily living activities, including the ADAS-Cog13 and ADCS-iADL scales. Phone calls before and after visits help track progress and adherence. Safety is closely monitored with ongoing assessments from screening through the 18-month treatment period.

Researchers are evaluating the safety, tolerability, and effectiveness of EIK1001 combined with standard treatments in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received vein-based treatment for their advanced disease. This phase 2, open-label, multicenter trial includes participants with confirmed stage 4 squamous or non-squamous NSCLC without mutations suitable for first-line targeted therapy. The study aims to find appropriate dosing and monitor adverse events alongside treatment response. Participants receive EIK1001, a Toll-like receptor 7/8 agonist, together with pembrolizumab, a PD-1 inhibitor, and chemotherapy drugs such as paclitaxel, pemetrexed, or carboplatin. These treatments are combined as part of the standard care for stage 4 NSCLC. The trial assesses safety and efficacy over the treatment period, including a dose-finding phase to determine the best dose of EIK1001. During the study, participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, organ function tests, and monitoring of performance status. Researchers track the percentage of participants experiencing safety events throughout up to two years of treatment. Follow-up includes ongoing evaluation of side effects and effectiveness to understand the treatment impact and participant well-being over the course of the trial.

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Researchers are evaluating the effectiveness of pemigatinib in adults with advanced or metastatic pancreatic cancer that has spread to nearby tissues, lymph nodes, or distant body parts, and that have specific genetic changes in the FGFR gene. The study focuses on patients whose cancer has FGFR2 gene fusions or other FGFR alterations, aiming to see if pemigatinib can block these abnormal gene functions to stop tumor growth and possibly improve quality of life. This is a phase II trial conducted nationwide using a fully decentralized telemedicine approach to reach participants. Participants receive pemigatinib as an oral medication once daily for 14 days within each 21-day cycle. Treatment continues unless the disease progresses or unacceptable side effects occur. Alongside the drug treatment, patients undergo various imaging tests including CT scans, MRI, optical coherence tomography (OCT), and when needed, whole body bone scans and dilated eye exams (ophthalmoscopy). After finishing treatment, patients are followed up at 30 days and then every four months for one year to monitor their condition. Throughout the study, patients provide blood samples and undergo scans to evaluate treatment response and detect resistance mutations. Researchers track the overall response rate for up to 24 months and assess safety and tolerability. Patients must comply with scheduled visits, tests, and oral medication intake. The total study participation includes treatment cycles and a follow-up period lasting up to approximately 16 months after treatment completion.

Researchers are evaluating the effect of baxdrostat combined with dapagliflozin compared to baxdrostat with placebo on reducing albuminuria in people with chronic kidney disease (CKD) and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes adults aged 18 years and older, with or without type 2 diabetes and regardless of current SGLT2 inhibitor treatment. The study aims to assess both the impact on albuminuria and the safety of these treatments. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or baxdrostat with a matching placebo. The study includes an optional pre-screening period to assess kidney function and other health markers, and those on SGLT2 inhibitors will undergo a washout before starting treatment. Randomization will consider diabetes status to ensure balanced groups. During the study, participants will be monitored up to 12 weeks to measure changes in albuminuria, specifically urinary albumin-to-creatinine ratio (UACR). Safety and other health parameters will also be assessed through blood tests and blood pressure measurements. The study ends when the last participant completes their final visit and procedures, ensuring thorough data collection on treatment effects and safety.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the long-term safety and effectiveness of the FDA-approved eCoin implanted tibial nerve stimulator in adults with overactive bladder (OAB) causing urgency urinary incontinence (UUI). This prospective, multicenter, single-arm study aims to observe real-world outcomes in people who have this condition and are suitable for this device treatment. Participants include men and women aged 18 and older, reflecting the disease prevalence in the U.S. The study involves implanting the eCoin device under the skin to stimulate the tibial nerve as a treatment for urgency urinary incontinence. Participants will receive this device once enrolled and are expected to complete voiding diaries and quality of life questionnaires during follow-up visits that extend up to five years. The device's stimulation aims to manage symptoms by targeting nerve pathways involved in bladder control. During the study, participants will be monitored regularly with assessments including voiding diaries and questionnaires to track their urinary symptoms and quality of life. Researchers will measure the responder rate at 12 months and monitor the safety by tracking any device or procedure-related adverse events over this period. The long-term follow-up of up to five years helps to assess ongoing safety and effectiveness of the eCoin implant.

Researchers are evaluating PRL-02 depot, a potential injectable treatment for men with advanced prostate cancer whose cancer has returned after previous treatments or did not respond well. This phase 1 study aims to assess the safety, tolerability, and appropriate dosing of PRL-02 depot when given alone or with another medicine called enzalutamide. The study includes men with different types of metastatic prostate cancer, including castration-resistant and castration-sensitive forms, some of whom have previously taken specific hormone therapies. The study is conducted in two parts. In the first part, small groups of men receive increasing doses of PRL-02 depot along with other medicines like dexamethasone, prednisone, or enzalutamide depending on the group. In the second part, men who have taken hormone therapy abiraterone acetate or one other hormone therapy participate. All men receive PRL-02 depot injections into a muscle every 12 weeks and take daily oral medications as per their group assignment. Participants will visit the clinic regularly for health checks, scans, and laboratory tests to monitor safety and effectiveness. Researchers will track side effects, laboratory and heart monitoring results, performance status, and testosterone levels over up to four years. Men whose cancer does not worsen after the study will continue with periodic health assessments and scans. The total participation time varies based on individual response and study progression.

Researchers are evaluating treatments for people with extensive stage small-cell lung cancer (ES-SCLC). This phase 3 study compares the effectiveness of adding tarlatamab to a combination of durvalumab, carboplatin, and etoposide against the combination without tarlatamab. The main goal is to see which treatment better prolongs overall survival and progression-free survival over about 3.5 years. Participants receive intravenous infusions of the study drugs. One group gets tarlatamab combined with durvalumab, carboplatin, and etoposide, while the other group receives durvalumab, carboplatin, and etoposide alone. All treatments are given as first-line therapy for their lung cancer. During the study, participants will be monitored regularly to assess their response to treatment and overall health. Researchers will measure overall survival and progression-free survival to evaluate treatment benefit. The study also involves ongoing safety monitoring, and participants will be followed for up to approximately 3.5 years to collect these outcomes.