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Researchers are evaluating the use of PET imaging with the radioligand 18FPI-2620 to detect tau protein deposits in people with Alzheimers disease and healthy controls. This open-label, multi-center, non-randomized Phase 3 study aims to compare PET imaging results during life with brain tissue analysis after death to better understand tau pathology in Alzheimers. The study is sponsored by Lantheus Biosciences Ltd. and focuses on diagnostic accuracy and safety of this imaging technique. Participants receive an intravenous injection of 18FPI-2620 at a dose of 185 MBq 20%. The study involves a PET scan procedure that participants must tolerate, including lying still in the scanner. There are no randomized groups or placebo controls as this is an open-label study. The research compares the PET imaging findings with post-mortem brain autopsy results to evaluate the ability of this imaging to detect tau deposits accurately. During the study, participants undergo PET imaging and are monitored for their ability to tolerate the scan. Brain donation consent is required for post-mortem histopathological comparison. Researchers assess the diagnostic performance of the PET scan in correctly identifying tau-related pathology and Alzheimers disease changes. The primary outcome focuses on the accuracy of visual assessment of PET images compared to autopsy findings, with follow-up continuing until study completion and an average of one year after death.

Researchers are investigating new treatments for neovascular age-related macular degeneration NVAMD, a condition that affects vision. This study aims to learn if a medicine called tiespectus also known as MK-8748 or EYE201 can treat NVAMD as well as the standard treatment called aflibercept. The trial is a pivotal Phase 23 study that compares these treatments in people newly diagnosed with NVAMD. Participants are randomly assigned to one of three groups one group receives a low dose of tiespectus, another receives a high dose of tiespectus, and the third group receives aflibercept. Those in the tiespectus groups get three initial injections every 4 weeks, then continue injections every 8 weeks until week 48, followed by treatments at intervals based on their individual response up to week 92. The aflibercept group receives three initial injections followed by injections every 8 weeks until week 92. During the study, participants are regularly assessed for changes in their best-corrected visual acuity using ETDRS letters from baseline to one year. Other evaluations include eye imaging to measure retinal thickness and monitoring for any adverse events up to approximately 96 weeks. The study lasts over one year with ongoing visits to track treatment response and safety.

This research investigates intravitreal EYE103 in adults with neovascular age-related macular degeneration NVAMD or macular edema caused by branch retinal vein occlusion BRVO. The trial is randomized and dose-masked, including four different patient groups to study different doses and combinations of EYE103, aiming to assess its effects in these eye conditions. Participants are divided into four cohorts treatment-naive NVAMD, incomplete responders IR with NVAMD as monotherapy, IR NVAMD combined with aflibercept, and treatment-naive BRVO. Each cohort randomly receives either a low or high dose of EYE103 via intravitreal injection. All receive three injections spaced 4 weeks apart the IR NVAMD combination group also receives aflibercept on Day 1. Assessments occur at each injection visit and some groups return 2 weeks post-injection for extra evaluations. During the 12-week study, participants undergo safety and efficacy assessments including vision tests using ETDRS charts, slit-lamp exams, fundoscopy, and imaging with spectral domain optical coherence tomography SD-OCT to measure retinal thickness. The studys main measure is the change in best-corrected visual acuity at Week 12. The trial also monitors retinal thickness and vision changes throughout. The Week 12 visit marks the studys end for all participants.

Researchers are evaluating the effectiveness of pegloticase administered by two different methodssubcutaneous under the skin injection versus intravenous into a vein infusioneach combined with methotrexate MTX in participants who have uncontrolled gout. The main goal is to compare how well these two treatment methods maintain normal serum uric acid levels over a six-month period. This Phase 3 trial is designed as a double-blind, randomized controlled study to provide reliable information on treatment responses.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are evaluating NEU-411 in adults aged 40 to 80 years who have early Parkinsons Disease PD with elevated activity in the LRRK2 pathway, identified through a genetic test. This Phase 2 study aims to assess the safety and effectiveness of NEU-411, a selective brain-penetrant inhibitor of LRRK2, compared to placebo in participants with LRRK2-driven PD. Participants will be randomly assigned to receive either NEU-411 at 30 mg once daily or a matching placebo for a 52-week treatment period. After this phase, participants may join an open-label extension to receive NEU-411 treatment for an additional 26 weeks. The study evaluates treatment effects on PD symptoms and adverse events. During the study, participants will undergo assessments including the Roche digital biomarker score using a Parkinsons Disease application and the Movement Disorder Societys Unified Parkinsons Disease Rating Scale. Safety monitoring includes tracking treatment-emergent and serious adverse events, with a follow-up visit scheduled within two weeks after treatment ends. Total study participation may extend up to 78 weeks including the extension phase.

Researchers are investigating the effects of APL-3007 combined with SyfovrePegcetacoplan APL-2 in patients with geographic atrophy caused by age-related macular degeneration AMD. This Phase 2 randomized, placebo-controlled study aims to assess the efficacy, safety, tolerability, and pharmacodynamics of these treatments in this eye condition. The study involves multiple centers and uses a masked design to ensure unbiased results. Participants will be assigned to one of three groups two receiving different doses or frequencies of APL-3007 in combination with pegcetacoplan APL-2, and one receiving a placebo along with pegcetacoplan APL-2. The study will evaluate the treatments given as multidose regimens. The treatments focus on complement C3 inhibition to potentially impact disease progression. Throughout the study, participants will undergo assessments including artificial intelligence-based imaging to measure retinal pigment epithelium lesion area and photoreceptor degeneration, safety evaluations through adverse event reporting and visual acuity tests, and blood tests to assess serum markers. These evaluations occur over 12 months to monitor changes from baseline. Participants involvement includes regular visits for these assessments, with the study tracking treatment effects and safety over the duration.

Researchers are studying the safety and effectiveness of intravitreal KSI-101 injections in adults with macular edema caused by inflammation, called Macular Edema Secondary to Inflammation MESI. This Phase 3 clinical trial aims to evaluate how well KSI-101 works compared to a sham injection in improving vision for people with this condition. Participants will receive one of three treatments KSI-101 at 5 mg or 10 mg doses injected into the eye every 4 weeks for six months, followed by dosing tailored to individual needs, or a sham injection following the same schedule. The study is randomized, double-masked, and controlled to ensure unbiased results. During the trial, participants will undergo vision tests to measure changes in best-corrected visual acuity BCVA over 24 weeks. Researchers will monitor safety and treatment effects throughout the study. The trial is expected to run until November 2027, with participants receiving regular assessments and follow-ups to track their eye health and response to treatment.