Stuart

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

Researchers are evaluating how well different doses of a medicine called BI 3812465 are tolerated in adults with diabetic macular edema that affects the center of the eye. This is the first time BI 3812465 is being given to humans. The study is a Phase IIIa trial conducted in two parts to investigate safety and tolerability of this treatment. In Part 1, a small group of participants receive low, medium, or high doses of BI 3812465 as injections into the back of the eye. Participants starting later receive higher doses only if lower doses are tolerated. In Part 2, a larger group is randomized into low, medium, or high dose groups, also receiving three eye injections of BI 3812465. The treatment is given sequentially with dose escalation based on safety. Participants stay in the study for up to seven months, attending 19 visits to the study site, with some visits possibly conducted at home. During these visits, doctors assess the severity of the eye condition and monitor any health problems related to the treatment. The study measures safety outcomes including dose limiting events and ocular adverse events over up to 169 days after treatment starts.

Researchers are evaluating disitamab vedotin alone or combined with pembrolizumab to treat urothelial cancer that expresses HER2. This study focuses on participants with locally advanced or metastatic urothelial cancer that cannot be removed by surgery. It aims to assess how well the drug works and to monitor the side effects experienced by participants. Participants receive disitamab vedotin intravenously every 2 weeks, either alone or with pembrolizumab given by intravenous infusion on Day 1 of each 6-week cycle. The study includes multiple cohorts receiving different combinations or monotherapy treatments. The treatment period and monitoring last approximately 2 years, with ongoing assessments of drug effects and safety. During the study, participants undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, electrocardiograms to monitor heart function, and assessments of side effects. Researchers measure treatment response using established cancer evaluation criteria and track survival and disease control over about 3 years. Participants are closely monitored for adverse effects and blood levels of the drugs to understand how the treatments behave in the body.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 years who have mild to severe Alzheimers Disease AD with moderate to severe psychosis related to AD. This Phase 3 study aims to compare KarXT with a placebo to see how well it works in treating psychosis symptoms associated with AD, focusing on changes in hallucinations and delusions. Participants will receive either KarXT capsules at varying doses or placebo capsules in a randomized, double-blind setup. The treatment period lasts up to 14 weeks, during which participants take the assigned capsules daily. The study design includes two groups running in parallel, with neither participants nor researchers knowing who receives the drug or placebo. During the study, participants will undergo assessments including the Neuropsychiatric Inventory-Clinician NPI-C focusing on hallucinations and delusions, Clinical Global Impressions-Severity scale, and other related scales to measure psychosis symptoms and caregiver distress. Safety and efficacy will be monitored throughout, with evaluations at baseline and at the end of treatment. The entire participation period extends up to 14 weeks.

Alzheimers disease AD is a progressive and irreversible neurological disorder that commonly causes dementia in older adults. This research aims to evaluate the safety, effects, and how the body processes ABBV-1758, an investigational drug developed to treat Alzheimers disease. The study is conducted in three stages, including dose escalation and expansion phases, involving approximately 210 participants across the United States, China, and Japan. Participants will receive intravenous IV or subcutaneous SC ABBV-1758 or placebo injections once every four weeks for a period of 24 weeks. The study includes a Follow-up Period lasting 12 weeks after treatment, and participants may opt to join a 12-month blinded Extension Period based on specific brain imaging results. Randomization assigns participants to different doses or placebo groups throughout the three stages, ensuring a 41 chance of receiving ABBV-1758 versus placebo. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor safety and treatment effects. Researchers will measure outcomes such as adverse events, changes in laboratory tests, brain amyloid levels, and other vital signs over approximately 40 weeks. The study emphasizes monitoring brain imaging abnormalities and drug levels in the body to better understand ABBV-1758s impact.

Researchers are studying the effects of KarXT combined with KarX-EC to treat cognitive impairment in people with mild to moderate Alzheimers Disease. This Phase 3 clinical trial aims to evaluate both the efficacy and safety of this treatment compared to a placebo, focusing on improving cognitive function and daily living activities over 24 weeks. Participants will be randomly assigned to receive either the active drugs KarXT and KarX-EC or a placebo, following specified dosing schedules. The study uses a double-blind, parallel-group design, meaning neither the participants nor the researchers know who receives the active treatment or placebo during the trial period. Participants will be monitored through various assessments including cognitive scales like the Alzheimers Disease Assessment Scale-Cognitive Subscale 11 ADAS-Cog11 and clinician interviews at baseline and week 24. Safety will be closely observed via monitoring adverse events, vital signs, laboratory tests, and heart function tests. The total duration of participation includes treatment and follow-up until study completion.

Researchers are evaluating the effects of a medicine called BI 1815368 in adults aged 18 and older who have a specific eye condition known as centre-involved diabetic macular edema CI-DME. This condition affects vision, and the study aims to find out if BI 1815368 can improve sight and to determine the best dose. The trial is a phase 2, randomized, double-masked, placebo-controlled study designed to assess efficacy, safety, and tolerability. The study has two parts. In the first part, participants are randomly assigned to one of two groups one receiving BI 1815368 tablets and the other receiving placebo tablets that look identical but contain no medicine. In the second part, participants are randomly assigned to one of four groups three groups receive different daily doses of BI 1815368, and one group receives placebo. All participants take the tablets twice daily for about 11 months. Participants stay in the study for about one year, during which they visit the study site 16 times. At these visits, doctors check vision, document any health problems, and take detailed eye pictures. Researchers compare changes over time between the groups to evaluate if the treatment affects vision. The main outcome measured is whether participants gain at least 10 Early Treatment Diabetic Retinopathy Study ETDRS letters in vision at Week 48 compared to baseline.

Researchers are investigating the safety and effectiveness of Accelerated Partial Breast Irradiation APBI using a specialized radiation technique called Stereotactic Body Radiation Therapy SBRT in women with certain types of breast cancer. This observational study focuses on women aged 50 to 100 with low to intermediate grade ductal carcinoma in situ or invasive ductal carcinoma, aiming to assess outcomes over a five-year follow-up period. Participants will receive a targeted radiation dose of 30 Gy divided into five treatments, delivered over alternating days within 5 to 10 days. Before treatment, fiducial markers are placed to guide precise radiation targeting. Imaging techniques such as CT scans, MRI, and PET may be used for motion assessment, and different equipment setups like gantry-based linear accelerators or robotic systems CyberKnife are utilized depending on the case. The radiation targets the tumor cavity with defined margins while protecting surrounding organs and tissues. During the study, participants will undergo regular imaging and assessments to monitor breast appearance, acute toxicities within 6 weeks, and late side effects up to 5 years. Researchers will measure cosmetic outcomes using standardized scales and record any adverse events related to treatment. The study includes detailed dosimetry and safety monitoring to evaluate the treatments impact over time.

Researchers are studying AV-1980R, an investigational vaccine aimed at targeting pathological tau protein in adults with preclinical Alzheimers disease. This Phase 1 trial involves up to 48 cognitively healthy adults aged 65 to 80 who show biomarker evidence of this early stage of Alzheimers. The studys main goal is to evaluate the safety and tolerability of the vaccine while also assessing immune responses and exploring changes in Alzheimers disease markers and cognitive function. Participants will be assigned to one of four groups in a randomized, double-blind design three groups receive different doses of AV-1980R vaccine 20 g, 60 g, or 180 g formulated with Advax-CpG55.2 adjuvant, and one group receives a placebo with the same formulation but without the active vaccine. Each participant will receive three intramuscular injections at Weeks 0, 4, and 38. The study includes follow-up visits through Week 58 to monitor safety and immune responses. During the trial, participants will undergo regular assessments including vital signs, laboratory tests, neurological exams, MRI scans, cognitive tests, and blood tests to measure anti-tau antibodies and T-cell responses. Researchers will monitor for any treatment-emergent adverse events and serious side effects from baseline through Week 58. The total participation period spans approximately 58 weeks, during which participants are closely observed for safety and immune response changes.

Researchers are evaluating bilateral pterygopalatine fossa PPF injections using a combination of 20mg ropivacaine and 4mg dexamethasone compared to saline placebo for treating headaches in survivors of aneurysmal subarachnoid hemorrhage SAH. This phase II, multicenter, randomized, double-blinded, placebo-controlled trial uses a sequential parallel comparison design to assess the interventions effects while monitoring intracranial arterial flow using transcranial Doppler TCD during the intervention period. Participants are randomly assigned to one of three groups Group 1 receives active PPF nerve blocks in both stages, Group 2 receives a placebo injection in the first stage followed by an active PPF nerve block in the second stage, and Group 3 receives placebo injections in both stages. The active nerve block consists of 20mg ropivacaine plus 4mg dexamethasone, while placebo injections consist of normal saline. The trial involves two stages of double-blinded treatment over 48 hours. During the study, participants are monitored for efficacy, safety, and tolerability outcomes within 24 to 48 hours after each PPF injection. Researchers assess headache relief and measure intracranial arterial flow velocities using TCD. Participants must be able to communicate their pain scores using an 11-point scale. The study lasts until the primary completion date with ongoing monitoring of treatment responses and adverse effects.