Olney

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 insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.

Researchers are evaluating whether sacituzumab tirumotecan alone or combined with pembrolizumab can treat people with triple-negative breast cancer TNBC that is locally recurrent, unresectable, or metastatic. The study aims to determine if these treatments help participants live longer overall or without their cancer growing or spreading compared to chemotherapy chosen by their physician. This is a phase 3, randomized, open-label trial focusing on patients whose tumors express PD-L1 at less than 10 combined positive score CPS. Participants are assigned to one of three groups. One group receives sacituzumab tirumotecan intravenously every two weeks until disease progression, toxicity, or stopping treatment. Another group gets the same sacituzumab tirumotecan schedule plus pembrolizumab intravenously every six weeks for up to about two years. The third group receives the physicians choice of chemotherapy, which may include paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin, given intravenously on various schedules until disease progression, toxicity, or discontinuation. Pre-medications are given before sacituzumab tirumotecan to help manage side effects. Participants will be monitored for how long they live without their cancer worsening and overall survival, with follow-up lasting up to around 61 months. Researchers will assess treatment response, quality of life using questionnaires, and physical and emotional functioning. Safety will be closely tracked by recording adverse events and treatment discontinuations. The total participation time depends on treatment duration and follow-up assessments.

Researchers are evaluating the safety, tolerability, and effectiveness of VIM0423, an oral medication, in adults with isolated dystonia affecting two or more body regions. This Phase 2, randomized, double-blind, placebo-controlled study aims to determine whether VIM0423 improves dystonia symptoms compared to placebo and whether it enhances daily function and quality of life. The trial addresses a significant need as many individuals lack approved treatments beyond botulinum toxin injections for limited dystonia types. Participants will be randomly assigned to receive either VIM0423 or a matching placebo, with up to six pills taken nightly before bed for 16 weeks. The study includes several phases screening and baseline period lasting up to 14 weeks with two visits, a 16-week treatment phase consisting of dose titration, maintenance, and taper with three visits, followed by a 2-week safety follow-up visit. The trial enrolls up to 120 adults aged 18 to 65 with isolated dystonia. Throughout participation, individuals will attend six in-person visits during the trial lasting up to 32 weeks. Assessments include clinical evaluations, video recordings to monitor dystonia changes, laboratory tests, EKGs, and monitoring for adverse events. Participants will also self-assess dystonia impact on daily living. The main outcome measured is the change in the Burke-Fahn-Marsden Dystonia Rating Scale from baseline to week 14, alongside other clinical and patient global impression scales to evaluate symptom severity and change.

This observational study focuses on people with Parkinsons disease who continue to have movement symptoms despite taking standard Parkinsons medications. Researchers aim to better understand how the disease progresses over time, the challenges faced by patients and their care partners, and how current treatments work in real life. The study is designed to fill gaps in knowledge by following patients longer and collecting comprehensive information. Participants will continue their usual treatments as determined by their doctors, without any investigational drugs or changes to their care plans. Data will be collected from patients and care partners through questionnaires, medical records, digital movement tracking devices, blood samples, and skin biopsies. The study includes a single group of patients with motor complications and their care partners. Participants will be followed for up to five years, with data collected on demographics, medical history, medications, movement and non-movement symptoms, genetics, and the burden of care. Researchers will use rating scales, diaries, and logs to assess symptoms and quality of life. The main outcomes include summaries of motor and non-motor symptoms, treatments received, and psychological and economic impacts on care partners.

Researchers are conducting an observational study focused on individuals diagnosed with isolated or primary dystonia affecting more than one body region. The study aims to collect detailed information to better understand how dystonia affects patients lives and how the disease changes over time. It also seeks to evaluate common clinical scales used to assess dystonia symptoms and their impact on well-being, pain, relationships, and social interactions. This study enrolls up to 200 male and female participants aged 12 to 65 years who have had isolated dystonia for at least one year. Participants must have segmental, multifocal, or generalized dystonia but not focal dystonia limited to a single body part. No interventional treatments are given, as this is a noninterventional, prospective observational study. Participants will undergo assessments using standardized rating scales, including the Burke-Fahn-Marsden Dystonia Rating Scale and other clinical measures, over a period of 4 months. Researchers will also collect medication history and monitor health events such as hospitalizations or new diagnoses. The data gathered will support future interventional studies and improve understanding of dystonia and clinical rating scales.

Researchers are investigating the effects of IGC-AD1, an oral medication containing THC and melatonin, on agitation in patients aged 60 and older with mild to severe Alzheimers dementia. The study is a multi-center, double-blind, randomized, placebo-controlled clinical trial aiming to assess how IGC-AD1 impacts agitation symptoms compared to a placebo. Participants must have clinically significant agitation lasting at least two weeks and meet specific criteria to ensure the agitation is related to Alzheimers dementia. Participants will receive either the active oral solution of IGC-AD1 or a placebo, both administered twice daily for 42 days followed by a two-day dose taper. The study includes safety monitoring with frequent phone calls to review medication use, adverse events, and study partner logbook entries. Blood samples will be taken during the trial to analyze drug levels, brain-related biomarkers, and genetic factors. During the study, participants and their caregivers will complete various assessments, including the Cohen-Mansfield Agitation Inventory CMAI to measure changes in agitation over six weeks and at two weeks. Safety and medication adherence will be closely monitored. The total participation time includes the treatment period and follow-up safety calls. Researchers will also evaluate secondary and exploratory outcomes related to agitation and collect pharmacokinetic data.

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating two digital mindfulness-based interventions to improve mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III randomized trial focuses on women diagnosed at or before age 50, who completed primary cancer treatments at least six months earlier. The study aims to compare the effectiveness of live instructor-led sessions via Zoom and a self-paced app-based program, exploring which approach best supports psychological health in this population. Participants will be assigned to one of three groups the live online mindfulness sessions MAPs LO conducted weekly for 6 weeks via Zoom, the MAPs App delivering the same content in shorter sessions over 6 weeks, or a meditation-only control group accessing guided audio meditations. Both English and Spanish speakers can participate in the live online and meditation groups, while the app is only available in English. Tablets and internet hotspots are provided if needed. All groups have access to the UCLA MARC mindfulness meditation app throughout the 6-month follow-up. During the study, participants will attend weekly sessions for the live group or engage with app content at home, with usage tracked to measure intervention dose. Researchers will assess depressive symptoms shortly after the intervention and again up to 6 months later, along with fatigue symptoms. They will also investigate factors influencing intervention effects, such as baseline distress and social determinants, and evaluate the cost-effectiveness of the programs. The total study duration includes a 6-week intervention period plus follow-up assessments out to 6 months.