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Researchers are evaluating MK-2214, a study treatment designed to slow brain changes in people with early Alzheimers disease AD. AD is a form of dementia that causes memory loss, communication difficulties, and challenges in decision-making, affecting daily tasks. This phase 2 trial aims to determine if MK-2214 slows the spread of tau protein in the brain compared to a placebo, as well as to assess the safety and tolerability of MK-2214. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous IV infusion every 4 weeks during the study. The study uses a parallel design with quadruple masking to compare the effects of the study drug versus placebo over a period of up to approximately 23 months. Both groups receive infusions on the same schedule to maintain the studys integrity. During the study, participants will undergo brain scans including positron emission tomography PET to measure tau protein levels and other assessments such as cognitive and daily living function tests. Researchers will monitor adverse events and treatment discontinuations throughout the study, which lasts up to about 26 months. These assessments help determine the impact of MK-2214 on disease progression and safety in individuals with early AD.

Researchers are studying the safety and effects of VHB937 in people with early Alzheimers disease, including those with Mild Cognitive Impairment due to Alzheimers or mild Alzheimers itself. This randomized, double-blind, placebo-controlled Phase II trial aims to evaluate whether VHB937 can benefit memory, thinking abilities, daily functioning, and brain changes. The study also looks at how the body processes VHB937 and responds to it. Participants receive intravenous infusions of either a low dose or high dose of VHB937, or a placebo, over a 72-week double-blind period. After this, an extension phase follows for further observation. The treatments are given through infusions, and participants are randomly assigned to one of the three groups in parallel. Throughout the study, participants and their study partners attend regular visits for assessments including clinical dementia rating scales, cognitive tests, daily living activities evaluation, and brain imaging biomarkers. Safety is monitored by tracking adverse events and serious adverse events. Blood samples are collected to measure VHB937 levels and immune responses. The total study duration includes the 72-week treatment period plus additional time in the extension phase.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the safety and effectiveness of ozanimod RPC1063 in helping children and teenagers with moderate to severe active ulcerative colitis UC who have not responded well to standard treatments. The study focuses on whether ozanimod can help achieve and maintain clinical remission in this young population. This research is conducted as a phase 2 and phase 3 trial sponsored by Bristol-Myers Squibb. Participants will receive ozanimod orally in either a high dose or low dose as part of the study. The treatment is given on specified days, and participants are randomly assigned to one of these dosing groups. The study uses a quadruple masking design, meaning that participants, caregivers, investigators, and assessors do not know which dose is given. The main study period will last up to 52 weeks, with ongoing assessments for up to 6 years to monitor longer-term outcomes and safety. During the study, participants will be monitored regularly for clinical remission, symptomatic remission, clinical response, and endoscopic improvement at various time points including weeks 10 and 52. Researchers will also track corticosteroid-free remission and measure blood levels of the drug and its metabolites. Safety is closely observed by recording adverse events, serious adverse events, and events leading to treatment discontinuation. The study involves clinical visits, endoscopic exams, and laboratory tests throughout the treatment and follow-up periods.

This research aims to evaluate whether participants who previously took donanemab receive clinical benefits from annual doses of the drug. The study focuses on individuals with Alzheimer Disease, Dementia, and Amyloid Plaque accumulation. Sponsored by Eli Lilly and Company, it is a phase 3 trial designed to assess the treatments effects over a long period. Participants are randomly assigned to receive either donanemab or a placebo through intravenous IV administration. The study follows a parallel design with double masking to compare the outcomes between the two groups. The treatment period lasts up to 2.5 years, during which participants will have six visits, including drug administration and monitoring. Throughout the study, participants will undergo evaluations such as the Clinical Dementia Rating - Sum of Boxes CDR-SB, Cognitive Function Index CFI, brain amyloid plaque imaging with Florbetapir F 18 PET scans, and plasma tests for phosphorylated tau protein. Pharmacokinetics of donanemab will be measured at baseline, week 52, and week 104. The study involves close monitoring of safety and clinical changes over the entire duration.

Researchers are evaluating whether donanemab slows the progression of cognitive decline, which affects thinking, learning, memory, attention, and decision-making, as well as functional decline impacting daily activities. This study focuses on adults aged 55 to 85 who have early cognitive decline along with Lewy Body Dementia features and confirmed brain amyloid and alpha-synuclein pathology. The trial is a phase 2 treatment study sponsored by Eli Lilly and Company, lasting one and a half years per participant. Participants are randomly assigned to receive either donanemab or a placebo, both given as intravenous infusions. Donanemab is being studied to assess its effects compared to placebo in this population. The treatment period lasts for 52 weeks, during which participants receive regular infusions under medical supervision. During the study, participants will undergo various assessments including cognitive and functional tests such as the Clinical Dementia Rating - Sum of Boxes CDR-SB, Integrated Alzheimers Disease Rating Scale iADRS, and Alzheimers Disease Assessment Scale - Cognitive Subscale ADAS-Cog13. Brain imaging and cerebrospinal fluid analysis will also be performed to measure amyloid plaque levels and alpha-synuclein pathology. Safety and drug levels in blood will be monitored throughout, with participants being followed closely for one and a half years total.

Researchers are evaluating the safety and tolerability of LY4006895, a study drug, in both healthy volunteers and participants with early symptomatic Alzheimers Disease AD. The study includes two parts Part A involves single-ascending doses in healthy participants, and Part B involves multiple-ascending doses in participants with early AD. The study aims to better understand how LY4006895 behaves in the body, including how much enters the bloodstream and how long it takes to be eliminated. Participants in Part A will receive single intravenous IV doses of LY4006895 or a placebo, while those in Part B will receive multiple IV doses of LY4006895 or placebo. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the drug or placebo. The entire study lasts approximately 29 weeks for Part A and 61 weeks for Part B, including screening periods. During the study, participants will have blood tests to measure drug levels and monitor safety. Researchers will track any treatment-related side effects, serious adverse events, and study discontinuations. Participants with early AD must have study partners who will assist with visits and provide consent. The primary outcome is the number of participants experiencing adverse events up to 61 weeks. The study includes regular assessments to ensure participant safety and gather pharmacokinetic data throughout the trial.

Crohns Disease CD is a digestive condition causing symptoms like chronic diarrhea, abdominal pain, weight loss, and fever. This research evaluates the pharmacokinetics, safety, and effectiveness of risankizumab in children aged 2 to under 18 years with moderately to severely active CD who have not responded well or cannot tolerate other treatments. Risankizumab is already approved for adults with certain inflammatory conditions and is now being studied for pediatric CD. The study includes three groups based on age, enrolling children from 2 to less than 18 years old. It has three parts an open-label 12-week induction phase where participants receive intravenous risankizumab based on their weight, a 52-week double-blind maintenance phase with subcutaneous risankizumab at one of two doses, and a 208-week open-label extension phase where treatment continues based on earlier responses. Participants who complete each phase may continue to the next, with dosing adjusted by age group. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, and questionnaires to monitor disease activity, side effects, and drug levels. Researchers will measure outcomes such as clinical remission and endoscopic response at 12 and 64 weeks, along with drug concentration in the blood. The total follow-up after treatment lasts about 140 days, with long-term monitoring during the extension phase.

This research aims to evaluate the long-term safety and tolerability of brivaracetam in children and adolescents with epilepsy, including those who participated in earlier studies or are newly enrolled in Japan with partial-onset seizures. The study also seeks to assess pharmacokinetic data in Japanese participants. The study is an open-label, single-arm, multicenter trial focusing on pediatric epilepsy treatment with brivaracetam. Participants will receive brivaracetam tablets or oral solution administered twice daily in two equal doses. Dosage varies based on weight up to 5 mgkgday for those weighing 11 to less than 20 kg, up to 4 mgkgday for those weighing 20 to less than 50 kg, and no more than 200 mgday. Directly enrolled participants in Japan will receive 1 to 4 mgkgday, not exceeding 200 mgday. The study includes long-term follow-up for up to 5 years. During the study, participants will be monitored for treatment-emergent adverse events, serious adverse events, and adverse events leading to discontinuation of the drug. Evaluations occur from Day 1 through safety visits over the 5-year period. Researchers will assess safety, tolerability, and pharmacokinetics. The total participation duration extends up to 5 years, with ongoing safety evaluations throughout this time.

Researchers are evaluating the pharmacokinetics, pharmacodynamics, efficacy, and safety of intravenous anifrolumab compared with placebo in children aged 5 to under 18 years with moderate to severe active systemic lupus erythematosus SLE who are receiving standard care. This phase III clinical trial aims to better understand how anifrolumab works and its effects in this pediatric population. Participants are randomly assigned to receive either anifrolumab or matching placebo via intravenous infusion every 4 weeks. The study includes several periods Part A is a 4-week double-blind pharmacokinetic phase Part B is a 48- to 52-week double-blind safety and efficacy phase Part C is a 52-week open-label extension and Part D involves a safety follow-up visit 12 weeks after the last dose. During the approximately 116-week study, participants undergo screening for up to 30 days, followed by regular infusions and assessments including blood tests to measure drug levels and immune markers. Researchers evaluate responses using disease activity scores and track safety throughout. The study concludes with a safety follow-up visit to monitor participants after completing treatment.